Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment?
Official Title
Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment?
Acronym
Not provided
Organization
Dartmouth-Hitchcock Medical CenterOTHER
Status Module
Record Verification Date
Oct 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 2014
Primary Completion Date
Sep 18, 2021Actual
Completion Date
Sep 18, 2021Actual
First Submitted Date
Oct 15, 2013
First Submission Date that Met QC Criteria
Oct 16, 2013
First Posted Date
Oct 17, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 18, 2024
Results First Submitted that Met QC Criteria
Nov 18, 2025
Results First Posted Date
Dec 9, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 18, 2025
Last Update Posted Date
Dec 9, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Mary F. Brunette, MD, Principal Investigator, Dartmouth-Hitchcock Medical CenterPrincipal Investigator
Lead Sponsor
Dartmouth-Hitchcock Medical CenterOTHER
Collaborators
Name
Class
Columbia University
OTHER
Harvard Medical School (HMS and HSDM)
OTHER
Massachusetts Institute of Technology
OTHER
Massachusetts General Hospital
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
In this translational research proposal, based on our formulation, we seek to confirm and expand upon data obtained in our pilot study suggesting that cannabis and the cannabinoid agonist dronabinol, given in low dose to patients with schizophrenia and co-occurring cannabis use disorder, will in fact ameliorate the brain reward circuit dysregulation in these patients and, thereby, provide evidence in support of the role of cannabis as a "self-medication" agent for them.
Detailed Description
Substance use disorders are strikingly common in patients with schizophrenia and contribute to its morbidity and cost to society. We have proposed a neurobiological formulation suggesting that cannabis and other substance use in these patients may ameliorate a dysfunction in the brain reward circuit(thus serving a "self-medication" function), while also worsening the symptoms and course of schizophrenia.
In this translational research proposal, based on our formulation, we seek to confirm and expand upon data obtained in our pilot study suggesting that cannabis and the cannabinoid agonist dronabinol, given in low dose to patients with schizophrenia and co-occurring cannabis use disorder, will in fact ameliorate the brain reward circuit dysregulation in these patients and, thereby, provide evidence in support of the role of cannabis as a "self-medication" agent for them. Also, by also testing the full range of effects produced by dronabinol (effects on brain reward circuitry assessed with task-based function MRI and resting state connectivity), as well as on reward responsiveness, mood, craving, cognition, psychiatric and extrapyramidal symptoms), we will provide clues as to whether dronabinol should be tried in low doses as an adjunctive agent (with an antipsychotic medication) to limit cannabis use in patients with schizophrenia.
This study will involve 8 groups of 25 participants each. Groups 1-3 will have diagnoses of schizophrenia and cannabis use disorder; Group 4 will have schizophrenia only, Groups 5-7 will have cannabis use disorder only and Group 8 will be healthy control participants. Following screening and baseline neuropsychiatric testing, participants will have two tests days (T1 and T2) that will include task-based functional MRI, including assessment of resting state connectivity, and measuring a number of other parameters including reward responsiveness, mood, craving, symptoms and cognition. The assessments at T1 will be virtually the same for all groups. At T2 Groups 1-3, and Groups 5-7 will be randomly assigned to one of the following conditions prior to the assessments: receiving 15mg of dronabinol and smoking a placebo marijuana cigarette, receiving a placebo pill and smoking a real marijuana cigarette, or receiving a placebo pill and smoking a placebo marijuana cigarette. Group 4 and Group 8 will receive no drug or placebo at T2. Participants receiving drug will have safety assessments before the drug is administered, after the drug is administered but before leaving the research clinic for the day, and again a week later.
Conditions Module
Conditions
Schizophrenia
Dual Diagnosis
Psychotic Disorder
Cannabis Use Disorder
Keywords
Dronabinol
Schizophrenia
Dual Diagnosis
Substance Abuse
Cannabis Use Disorder
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
263Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Marijuana cigarette and placebo capsule
Experimental
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Drug: Marijuana
Dronabinol and placebo cigarette
Experimental
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Drug: Dronabinol
Placebo cigarette and placebo capsule
Placebo Comparator
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Marijuana
Drug
Smoked plant with THC
Marijuana cigarette and placebo capsule
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Brain Reward Circuit Activation on fMRI Scan
Activation of the Brain Reward Circuit (particularly the nucleus accumbens) in anticipation of monetary reward. The 'Measure' is a mean of the Fisher-Z transform of the inter-regional correlation measured for each participant between the nucleus accumbens and anterior cingulate cortex. The Fisher-transformation creates a normally distributed correlation value for statistical analyses assessing between group differences. A Fisher-Z transform of '0' represents a value of '0' for the estimated correlation, which represents no correlation in the activity time series between the regions. The values reflect strengths of functional connectivity between brain regions that can be compared between groups (e.g. Healthy controls and SCZ-CUD groups who received different study drugs). Means and standard deviations similar to healthy controls would be considered a good outcome.
3 hours
Resting State Connectivity Within the Brain Reward Circuitry
Resting state connectivity within brain reward circuitry as measured with the Fisher-transformed r value of the connectivity maps between the nucleus accumbans and other brain areas. The Fisher-transformation creates a normally distributed correlation value for statistical analyses assessing between group differences (smoked THC vs placebo; oral dronabinol vs placebo)
1 hour after smoking study drug, 3 hours after oral dronabinol
Secondary Outcomes
Measure
Description
Time Frame
PANSS Positive Symptoms
Positive and Negative Symptom Scale (PANSS) Positive Symptom Mean Subscale Score at 2nd Assessment Day, range 7-49, higher = more symptoms. The outcome measure was recorded at single time of measurement. The time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Groups 1-3 Participants with schizophrenia and a cannabis use disorder
Ages 18 - 55 years
Diagnosis of schizophrenia
Diagnosis of cannabis abuse or dependence
Use of cannabis within the month prior to screening
Willing to remain abstinent for the 14 days before the baseline assessments and throughout the two scans.
Psychiatrically stable
Treated with a stable dose of an antipsychotic medication (except clozapine) for the past month
Not seeking treatment for their cannabis use disorder.
Group 4 - Control participants with schizophrenia
Ages 18 - 55 years
Diagnosis of schizophrenia
Willing to remain abstinent as described above
Psychiatrically stable
Treated with a stable dose of an antipsychotic medication (except clozapine) for the past month
Groups 5-7 - Control participants with cannabis use disorder
Ages 18 - 55 years
Diagnosis of cannabis abuse or dependence
Use of cannabis within the month prior to screening
Willing to remain abstinent as described above
Not seeking treatment for their cannabis use disorder.
Group 8 - Healthy control participants
Ages 18 - 55 years
Willing to remain abstinent as described above
Exclusion criteria:
Groups 1-3 with schizophrenia and a cannabis use disorder
Positive symptoms of psychosis (> 4 [moderate]) on any item of the Positive and Negative Syndrome Scale psychosis subscale (once abstinent) except for the hallucination item. We will exclude for a rating > 5 for this item.
Cocaine/stimulant use disorder
Pharmacological treatment for addiction
Mental retardation
History of head injury
Metal objects within the body that would contraindicate and MRI
Pregnancy or currently nursing
Uncontrolled medical condition
Taking clozapine
Any condition that would contraindicate use of cannabis or dronabinol.
History of a seizure disorder
Group 4 - Control participants with schizophrenia
Positive symptoms of psychosis (> 4 [moderate]) on any item of the Positive and Negative Syndrome Scale psychosis subscale (once abstinent) except for the hallucination item. We will exclude for a rating > 5 for this item.
Any history of a substance use disorder other than nicotine
Pharmacological treatment for addiction
Mental retardation
History of head injury
Metal objects within the body that would contraindicate and MRI
Pregnancy or currently nursing
Uncontrolled medical condition
Taking clozapine
Groups 5-7 - Control participants with cannabis use disorder
Axis I psychiatric diagnosis other than a cannabis use disorder
Taking any psychotropic medication
Pharmacological treatment for addiction
Mental retardation
History of head injury
Metal objects within the body that would contraindicate and MRI
Pregnancy or currently nursing
Uncontrolled medical condition
History of a seizure disorder
Group 8 - Healthy control participants
Any Axis I psychiatric diagnosis
Taking any psychotropic medication
Pharmacological treatment for addiction
Mental retardation
History of head injury
Metal objects within the body that would contraindicate and MRI
Pregnancy or currently nursing
Uncontrolled medical condition
Current tobacco smokers
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
55 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Mary F Brunette, MD
Dartmouth College
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Dartmouth Hitchcock Medical Center
Lebanon
New Hampshire
03756
United States
University of Vermont
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cannabis Use Disorder
Participants met criteria for Cannabis Use Disorder (CUD)
FG001
Dual Diagnosis (Schizophrenia and Cannabis Use Disorder)
Participants with a Dual Diagnosis of Schizophrenia and Cannabis Use Disorder
FG002
Schizophrenia
Participants diagnosed with Schizophrenia
FG003
Healthy Controls
Participants with no mental health diagnosis or cannabis use
FG004
Marijuana Cigarette and Placebo Capsule CUD Only
Participants with Cannabis Use Disorder (CUD) and randomized to receive Marijuana Cigarette and Placebo Capsule
FG005
Dronabinol and Placebo Cigarette CUD Only
Participants met criteria for Cannabis Use Disorder (CUD) and were randomized to Dronabinol and Placebo Cigarette
FG006
Placebo Cigarette and Placebo Capsule CUD Only
Participants with a diagnosis of Cannabis Use Disorder (CUD) randomized to Placebo Dronabinol and Placebo Cigarette
FG007
Marijuana Cigarette and Placebo Capsule - SCZ-CUD
Participants with Dual Diagnosis of Schizophrenia and Cannabis Use Disorder (SCZ-CUD) and randomized to Marijuana Cigarette and Placebo Capsule - SCZ-CUD
FG008
Dronabinol and Placebo Cigarette - SCZ-CUD
Participants diagnosed with Diagnosis Schizophrenia and Cannabis Use Disorder and randomized to Dronabinol and Placebo Cigarette
FG009
Placebo Cigarette and Placebo Capsule - SCZ-CUD
Participants diagnosed with Schizophrenia and Cannabis Use Disorder and randomized to placebo Cigarette and Placebo Capsule
Periods
Title
Milestones
Reasons Not Completed
Pre-Randomization - Scan 1
Type
Comment
Milestone Data
STARTED
Consented and Screened
FG000111 subjects
FG00179 subjects
FG00233 subjects
FG00340 subjects
FG004
Enrolled and Completed Neuropsych Testing
FG00062 subjects
FG00143 subjects
FG00221 subjects
FG00331 subjects
Completed Scan 1
FG00054 subjects
FG00135 subjects
FG00218 subjects
FG00328 subjects
FG004
COMPLETED
FG00051 subjects
FG00134 subjects
FG00218 subjects
FG00327 subjects
FG004
NOT COMPLETED
FG00060 subjects
FG00145 subjects
FG00215 subjects
FG00313 subjects
FG004
Type
Comment
Reasons
Screen Fail
FG00049 subjects
FG00136 subjects
FG00212 subjects
FG003
Randomization - Scan 2
Type
Comment
Milestone Data
STARTED
Randomized
FG0000 subjects
FG0010 subjects
FG00218 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
The baseline data includes all participants who were enrolled and completed Neuropsych Testing. Groups have been partitioned to reflect individuals who completed Period 1 (Pre-Randomization -Scan 1) and Period 2 (Randomization- Scan 2)
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Marijuana Cigarette and Placebo Capsule SCZ-CUD
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
BG001
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Brain Reward Circuit Activation on fMRI Scan
Activation of the Brain Reward Circuit (particularly the nucleus accumbens) in anticipation of monetary reward. The 'Measure' is a mean of the Fisher-Z transform of the inter-regional correlation measured for each participant between the nucleus accumbens and anterior cingulate cortex. The Fisher-transformation creates a normally distributed correlation value for statistical analyses assessing between group differences. A Fisher-Z transform of '0' represents a value of '0' for the estimated correlation, which represents no correlation in the activity time series between the regions. The values reflect strengths of functional connectivity between brain regions that can be compared between groups (e.g. Healthy controls and SCZ-CUD groups who received different study drugs). Means and standard deviations similar to healthy controls would be considered a good outcome.
Posted
Mean
Standard Deviation
z-score
3 hours
ID
Title
Description
OG000
Marijuana cigarette and placebo capsule SCZ-CUD
Adverse Events Module
Frequency Threshold
0
Time Frame
Since past assessment (1-2 weeks)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Marijuana cigarette and placebo capsule SCZ-CUD
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Positive and Negative Symptom Scale Negative Symptom Mean Subscale Score at 2nd Assessment Day, range 7-49, higher = more symptoms. The time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.
3 hours after oral THC/placebo
Cognitive Functioning, Verbal Learning
Cognitive functioning, verbal learning Hopkins Verbal Learning Test (HVLT-R) total raw score. Possible range of scores is 0-35, higher is better functioning. The time frame includes 4 hours after oral THC/placebo and 2 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.
4 hours after oral drug
Drug Experience, Anxiety
Drug experience ratings of mood and desirability, anxiety rating on a scale of 0-100, higher means more anxiety.
The time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.
3 hours after taking oral drug
Drug Experience Ratings of Drug Liking
Drug experience ratings of liking rating on a scale of 0-100, higher number = more liking
The time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.
3 hours after taking oral drug
Cognitive Function, CPT-IP 2 Digit
Cognitive function, CPT-IP 2 digit measure of Attention. The Continuous Performance Test-Identical Pairs version (CPT-IP)80 assessed attention with range of 1-5, hirer scores indicating better function
The outcome measure was recorded at single time of measurement. The time frame includes 4 hours after oral THC/placebo and 2 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.
4 hours after oral drug
Burlington
Vermont
05401
United States
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG004
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
9 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Withdrawal by Subject
FG0008 subjects
FG0018 subjects
FG0023 subjects
FG0033 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Withdrawal by Subject
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
27 subjects
FG00417 subjects
FG00517 subjects
FG00617 subjects
FG00711 subjects
FG00812 subjects
FG00911 subjects
COMPLETED
Completed Scan 2
FG0000 subjects
FG0010 subjects
FG00218 subjects
FG00327 subjects
FG00417 subjects
FG00517 subjects
FG00617 subjects
FG00711 subjects
FG00812 subjects
FG00911 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Dronabinol and Placebo Cigarette SCZ-CUD
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
BG002
Placebo Cigarette and Placebo Capsule. SCZ-CUD
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
BG003
SCZ-CUD Not Randomized
Dual diagnosis of Schizophrenia and Cannabis Use disorder, - Completed Scan 1 but not Randomized
BG004
Marijuana Cigarette and Placebo Capsule CUD Only
CUD only 3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant
BG005
Dronabinol and Placebo Cigarette CUD Only
CUD only Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
BG006
Placebo Cigarette and Placebo Capsule CUD Only
CUD only Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
BG007
Cannabis Use Disorder - CUD Did Not Randomize
Cannabis Use Disorder (CUD), Completed Scan 1 but not Randomized
BG008
SCZ Only
No drug intervention - Completed Scan 1 and 2
BG009
SCZ Only - Did Not Complete Scan 2
No drug intervention - Completed Scan 1 but not Scan 2
BG010
Healthy Control -
No drug intervention - Completed Scan 1 and 2
BG011
Healthy Control - Did Not Complete Scan 2
No drug intervention - Completed Scan 1 but not Scan 2
BG012
Total
Total of all reporting groups
11
BG00112
BG00211
BG0038
BG00417
BG00517
BG00617
BG00710
BG00818
BG0093
BG01027
BG0114
BG012155
Full Range
Years
Title
Denominators
Categories
ParticipantsBG00011
ParticipantsBG00112
ParticipantsBG00211
ParticipantsBG0038
ParticipantsBG00417
ParticipantsBG00517
ParticipantsBG00617
ParticipantsBG00710
ParticipantsBG00818
ParticipantsBG0093
ParticipantsBG01027
ParticipantsBG0114
ParticipantsBG012155
Title
Measurements
BG00033.00(20 to 45)
BG00128.42(21 to 46)
BG00231.55(21 to 45)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00011
ParticipantsBG00112
ParticipantsBG00211
ParticipantsBG0038
ParticipantsBG00417
ParticipantsBG00517
ParticipantsBG00617
ParticipantsBG00710
ParticipantsBG00818
ParticipantsBG0093
ParticipantsBG01027
ParticipantsBG0114
ParticipantsBG012155
Title
Measurements
Female
BG0002
BG0013
BG0021
BG003
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00011
ParticipantsBG00112
ParticipantsBG00211
ParticipantsBG0038
ParticipantsBG00417
ParticipantsBG00517
ParticipantsBG00617
ParticipantsBG00710
ParticipantsBG00818
ParticipantsBG0093
ParticipantsBG01027
ParticipantsBG0114
ParticipantsBG012155
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG0021
BG003
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00011
ParticipantsBG00112
ParticipantsBG00211
ParticipantsBG0038
ParticipantsBG00417
ParticipantsBG00517
ParticipantsBG00617
ParticipantsBG00710
ParticipantsBG00818
ParticipantsBG0093
ParticipantsBG01027
ParticipantsBG0114
ParticipantsBG012155
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG003
Education, years
Mean
Standard Deviation
Years
Title
Denominators
Categories
ParticipantsBG00011
ParticipantsBG00112
ParticipantsBG00211
ParticipantsBG0038
ParticipantsBG00417
ParticipantsBG00517
ParticipantsBG00617
ParticipantsBG00710
ParticipantsBG00818
ParticipantsBG0093
ParticipantsBG01027
ParticipantsBG0114
ParticipantsBG012155
Title
Measurements
BG00012.45± 1.695
BG00113.92± 1.782
BG00213.82± 1.722
BG003
Schizophrenia, schizoaffective diagnosis
Number
participants
Title
Denominators
Categories
Schizophrenia disorder
ParticipantsBG00011
ParticipantsBG00112
ParticipantsBG00211
ParticipantsBG0038
ParticipantsBG00417
ParticipantsBG00517
ParticipantsBG00617
ParticipantsBG00710
ParticipantsBG00818
ParticipantsBG0093
ParticipantsBG01027
ParticipantsBG0114
ParticipantsBG012155
Title
Measurements
BG0003
BG0014
BG0024
BG003
Schizoaffective disorder
ParticipantsBG00011
ParticipantsBG00112
ParticipantsBG00211
ParticipantsBG0038
PANSS
Positive and Negative Syndrome Scale; Range 7-49, higher score = higher levels of symptoms
Measure only collected for subjects with SCZ and SCZ-CUD
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Positive
ParticipantsBG00011
ParticipantsBG00112
ParticipantsBG00211
ParticipantsBG0038
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG00818
ParticipantsBG0093
ParticipantsBG0100
ParticipantsBG0110
ParticipantsBG01263
Title
Measurements
BG00012.09± 3.91
BG00112.83± 3.74
BG00212.82± 3.34
BG003
Negative
ParticipantsBG00011
ParticipantsBG00112
ParticipantsBG00211
ParticipantsBG0038
Days of Cannabis Use in Past 35
Days of cannabis use in past 35, range 0-35 days possible
Mean
Standard Deviation
Days
Title
Denominators
Categories
ParticipantsBG00011
ParticipantsBG00112
ParticipantsBG00211
ParticipantsBG0038
ParticipantsBG00417
ParticipantsBG00517
ParticipantsBG00617
ParticipantsBG00710
ParticipantsBG00818
ParticipantsBG0093
ParticipantsBG01027
ParticipantsBG0114
ParticipantsBG012155
Title
Measurements
BG00010.73± 9.30
BG00116.92± 10.10
BG00216.64± 10.96
BG003
Number of Joints Smoked in Past 35 days
Mean
Standard Deviation
Number of Joints
Title
Denominators
Categories
ParticipantsBG00011
ParticipantsBG00112
ParticipantsBG00211
ParticipantsBG0038
ParticipantsBG00417
ParticipantsBG00517
ParticipantsBG00617
ParticipantsBG00710
ParticipantsBG00818
ParticipantsBG0093
ParticipantsBG01027
ParticipantsBG0114
ParticipantsBG012155
Title
Measurements
BG00018.41± 26.99
BG00122.19± 18.82
BG00219.70± 16.01
BG003
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
OG001
Dronabinol and placebo cigarette. SCZ-CUD
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
OG002
Placebo cigarette and placebo capsule. SCZ-CUD
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
OG003
Marijuana cigarette and placebo capsule CUD only
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
OG004
Dronabinol and placebo cigarette CUD only
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
OG005
Placebo cigarette and placebo capsule. CUD only
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
OG006
SCZ only
This group of subjects did not have CUD and received no intervention
OG007
Healthy Controls
This group of healthy subjects had no illness and received no intervention
Units
Counts
Participants
OG00011
OG00112
OG00211
OG00318
OG00417
OG00517
OG00617
OG00727
Title
Denominators
Categories
Title
Measurements
OG0000.05± 0.098
OG0010.14± 0.076
OG0020.18± 0.127
OG0030.12± 0.058
OG0040.10± 0.087
OG0050.11± 0.081
OG0060.17± 0.094
OG0070.17± 0.121
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
t-test, 2 sided
0.87
p-FDR
Mean Difference (Final Values)
-0.13
2-Sided
Superiority
Primary
Resting State Connectivity Within the Brain Reward Circuitry
Resting state connectivity within brain reward circuitry as measured with the Fisher-transformed r value of the connectivity maps between the nucleus accumbans and other brain areas. The Fisher-transformation creates a normally distributed correlation value for statistical analyses assessing between group differences (smoked THC vs placebo; oral dronabinol vs placebo)
Data was collected but cannot be compiled and analysis could not be completed due to death of PI and resulting limited resources for scan data compilation and analyses. There are no immediate resources for analysis in the future.
Posted
1 hour after smoking study drug, 3 hours after oral dronabinol
ID
Title
Description
OG000
Marijuana cigarette and placebo capsule SCZ-CUD
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
OG001
Dronabinol and placebo cigarette. SCZ-CUD
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
OG002
Placebo cigarette and placebo capsule. SCZ-CUD
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
OG003
Marijuana cigarette and placebo capsule CUD only
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
OG004
Dronabinol and placebo cigarette CUD only
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
OG005
Placebo cigarette and placebo capsule. CUD only
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
OG006
SCZ only
This group of subjects did not have CUD and received no intervention
OG007
Healthy Controls
This group of healthy subjects had no illness and received no intervention
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
PANSS Positive Symptoms
Positive and Negative Symptom Scale (PANSS) Positive Symptom Mean Subscale Score at 2nd Assessment Day, range 7-49, higher = more symptoms. The outcome measure was recorded at single time of measurement. The time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.
Only participants with Schizophrenia were assessed using the Positive and Negative Symptom Scale, as specified in the Study Protocol
Posted
Mean
Standard Error
score on a scale
3 hours after oral THC/placebo
ID
Title
Description
OG000
Marijuana cigarette and placebo capsule SCZ-CUD
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
OG001
Dronabinol and placebo cigarette. SCZ-CUD
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
OG002
Placebo cigarette and placebo capsule. SCZ-CUD
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
OG003
SCZ only
This group of subjects did not have CUD and received no intervention
Units
Counts
Participants
OG00011
OG00112
OG00211
OG003
Title
Denominators
Categories
Title
Measurements
OG00011.0± 0.54
OG0019.3± 0.40
OG00210.2± 0.56
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
OG003
This analysis tested whether the marijuana cigarette group had different PANSS Positive symptom scores compared to the placebo group adjusting for the SCZ only group. (The dronabinol group was tested separately per our analytic plan.)
ANOVA
0.31
Mean Difference (Final Values)
0.82
Standard Error of the Mean
0.81
2-Sided
95
-0.77
2.4
Superiority
Secondary
PANSS Negative Symptoms
Positive and Negative Symptom Scale Negative Symptom Mean Subscale Score at 2nd Assessment Day, range 7-49, higher = more symptoms. The time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.
This analysis tested whether the marijuana cigarette group had different PANSS negative symptom scores compared to the placebo group adjusting for the SCZ only group. (The dronabinol group was tested separately per our analytic plan.). Only participants with Schizophrenia were assessed using the Positive and Negative Symptom Scale, as specified in the Study Protocol.
Posted
Mean
Standard Error
score on a scale
3 hours after oral THC/placebo
ID
Title
Description
OG000
Marijuana cigarette and placebo capsule SCZ-CUD
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
OG001
Dronabinol and placebo cigarette. SCZ-CUD
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
OG002
Placebo cigarette and placebo capsule. SCZ-CUD
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
OG003
SCZ only
This group of subjects did not have CUD and received no intervention
Units
Counts
Participants
OG0009
OG00112
OG00211
OG003
Title
Denominators
Categories
Title
Measurements
OG00017.1± 0.76
OG00116.4± 0.67
OG00215.8± 0.81
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
OG003
This analysis tested whether the marijuana cigarette group had different PANSS Negative symptom scores compared to the placebo group adjusting for the SCZ only group. (The dronabinol group was tested separately per our analytic plan.)
ANOVA
0.28
Mean Difference (Final Values)
1.2
2-Sided
95
-1
3.45
Superiority
OG001
Secondary
Cognitive Functioning, Verbal Learning
Cognitive functioning, verbal learning Hopkins Verbal Learning Test (HVLT-R) total raw score. Possible range of scores is 0-35, higher is better functioning. The time frame includes 4 hours after oral THC/placebo and 2 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.
Posted
Mean
Standard Deviation
score on a scale
4 hours after oral drug
ID
Title
Description
OG000
Marijuana cigarette and placebo capsule SCZ-CUD
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
OG001
Dronabinol and placebo cigarette. SCZ-CUD
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
OG002
Placebo cigarette and placebo capsule. SCZ-CUD
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
OG003
Marijuana cigarette and placebo capsule CUD only
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
OG004
Dronabinol and placebo cigarette CUD only
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
OG005
Placebo cigarette and placebo capsule. CUD only
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
OG006
SCZ only
This group of subjects did not have CUD and received no intervention
OG007
Healthy Controls
This group of healthy subjects had no illness and received no intervention
Units
Counts
Participants
OG0009
OG00112
OG00211
OG003
Title
Denominators
Categories
Title
Measurements
OG00023.2± 6.8
OG00121.8± 6.7
OG00225.0± 5.0
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
This analysis tested whether the dronabinol group had different verbal learning scores compared to the placebo group adjusting for the SCZ only group. (The marijuana cigarette group was tested separately per our analytic plan.)
Regression, Linear
Adjusted for pre-drug exposure cognitive functioning
0.004
We set threshold of p<.01 for statistical significance due to multiple comparisons
Mean Difference (Final Values)
-9.98
Standard Error of the Mean
3.424
2-Sided
95
-16.06
-3.18
Superiority
Secondary
Drug Experience, Anxiety
Drug experience ratings of mood and desirability, anxiety rating on a scale of 0-100, higher means more anxiety.
The time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.
Only participants with Schizophrenia and CUD who were given study drug were analyzed for drug experiences, as specified in the Study Protocol
Posted
Mean
Standard Deviation
units on a scale
3 hours after taking oral drug
ID
Title
Description
OG000
Marijuana cigarette and placebo capsule SCZ-CUD
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
OG001
Dronabinol and placebo cigarette. SCZ-CUD
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
OG002
Placebo cigarette and placebo capsule. SCZ-CUD
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
OG003
SCZ only
This group of subjects did not have CUD and received no intervention
Units
Counts
Participants
OG00010
OG00112
OG00211
OG003
Title
Denominators
Categories
Title
Measurements
OG00010.03± 4.64
OG0013.88± 2.06
OG0023.96± 2.30
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
OG003
This analysis tested whether the marijuana cigarette group had different anxiety scores compared to the placebo group adjusting for the SCZ only group. (The dronabinol group was tested separately per our analytic plan.)
Regression, Linear
.22
Mean Difference (Final Values)
6.07
Standard Error of the Mean
4.94
2-Sided
95
-3.62
15.75
Superiority
Secondary
Drug Experience Ratings of Drug Liking
Drug experience ratings of liking rating on a scale of 0-100, higher number = more liking
The time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.
Only participants with Schizophrenia and CUD who were given study drug were analyzed for drug experiences, as specified in the Study Protocol
Posted
Mean
Standard Error
units on a scale
3 hours after taking oral drug
ID
Title
Description
OG000
Marijuana cigarette and placebo capsule SCZ-CUD
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
OG001
Dronabinol and placebo cigarette. SCZ-CUD
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
OG002
Placebo cigarette and placebo capsule. SCZ-CUD
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
Units
Counts
Participants
OG00010
OG00112
OG00211
Title
Denominators
Categories
Title
Measurements
OG00056.5± 21.66
OG00156.36± 20.10
OG0025.54± 3.49
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
This analysis tested whether the dronabinol group had different drug experience ratings of liking scores compared to the placebo group. (The marijuana cigarette group was tested separately per our analytic plan.)
ANOVA
0.13
Mean Difference (Final Values)
50.91
Standard Error of the Mean
20.4
2-Sided
95
10.9
90.9
Superiority
Secondary
Cognitive Function, CPT-IP 2 Digit
Cognitive function, CPT-IP 2 digit measure of Attention. The Continuous Performance Test-Identical Pairs version (CPT-IP)80 assessed attention with range of 1-5, hirer scores indicating better function
The outcome measure was recorded at single time of measurement. The time frame includes 4 hours after oral THC/placebo and 2 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.
Posted
Mean
Standard Deviation
score on a scale
4 hours after oral drug
ID
Title
Description
OG000
Marijuana cigarette and placebo capsule SCZ-CUD
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
OG001
Dronabinol and placebo cigarette SCZ-CUD
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
OG002
Placebo cigarette and placebo capsule. SCZ-CUD
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
OG003
Marijuana cigarette and placebo capsule CUD only
CUD only 3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant
OG004
Dronabinol and placebo cigarette CUD only
CUD only Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
OG005
Placebo cigarette and placebo capsule CUD only
CUD only Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
OG006
SCZ only
No drug intervention - Completed Scan 1 and 2
OG007
Healthy Control -
No drug intervention - Completed Scan 1 and 2
Units
Counts
Participants
OG00011
OG00112
OG00211
OG003
Title
Denominators
Categories
Title
Measurements
OG0003.5± 0.7
OG0013.3± 0.9
OG0023.7± 0.7
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Regression, Linear
0.002
Mean Difference (Final Values)
-0.43
Standard Error of the Mean
0.178
2-Sided
95
-1.0
-0.23
Superiority
0
11
1
11
9
11
EG001
Dronabinol and placebo cigarette SCZ-CUD
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
0
12
0
12
9
12
EG002
Placebo cigarette and placebo capsule. SCZ-CUD
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
0
11
1
11
8
11
EG003
SCZ-CUD not randomized
Dual diagnosis of Schizophrenia and Cannabis Use disorder, - Completed Scan 1 but not Randomized
0
8
1
8
2
8
EG004
Marijuana cigarette and placebo capsule CUD only
CUD only 3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant
0
17
0
17
14
17
EG005
Dronabinol and placebo cigarette CUD only
CUD only Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
0
17
0
17
10
17
EG006
Placebo cigarette and placebo capsule CUD only
CUD only Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
0
17
0
17
14
17
EG007
Cannabis Use Disorder - CUD Did not randomize
Cannabis Use Disorder (CUD), Completed Scan 1 but not Randomized
0
10
1
10
5
10
EG008
SCZ only
No drug intervention - Completed Scan 1 and 2
0
18
2
18
13
18
EG009
SCZ only - Did not complete Scan 2
No drug intervention - Completed Scan 1 but not Scan 2
0
3
0
3
3
3
EG010
Healthy Control -
No drug intervention - Completed Scan 1 and 2
0
27
0
27
14
27
EG011
Healthy Control - Did not complete Scan 2
No drug intervention - Completed Scan 1 but not Scan 2
0
4
0
4
0
4
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected11 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected17 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
Vyvanse Intoxication
Psychiatric disorders
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected17 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
Injury
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected17 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected10 at risk
EG0081 events1 affected18 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
Hallucinations
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected17 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected10 at risk
EG0081 events1 affected18 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
Chest Pain
Cardiac disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected17 at risk
EG0060 events0 affected17 at risk
EG0071 events1 affected10 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
EG0003 events3 affected11 at risk
EG0012 events2 affected12 at risk
EG0022 events2 affected11 at risk
EG0030 events0 affected8 at risk
EG0044 events4 affected17 at risk
EG0053 events2 affected17 at risk
EG0061 events1 affected17 at risk
EG0071 events1 affected10 at risk
EG0081 events1 affected18 at risk
EG0091 events1 affected3 at risk
EG0102 events2 affected27 at risk
EG0110 events0 affected4 at risk
Hallucinations
Psychiatric disorders
Systematic Assessment
EG0003 events3 affected11 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected17 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected10 at risk
EG0082 events2 affected18 at risk
EG0091 events1 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
Increased cannabis withdrawal symptoms
Psychiatric disorders
Systematic Assessment
EG0006 events3 affected11 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected17 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
Psychiatric symptoms
Psychiatric disorders
Systematic Assessment
EG0003 events2 affected11 at risk
EG0012 events2 affected12 at risk
EG0023 events3 affected11 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected17 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
Tachycardia
Cardiac disorders
Systematic Assessment
EG0002 events2 affected11 at risk
EG0012 events2 affected12 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected8 at risk
EG0046 events6 affected17 at risk
EG0053 events3 affected17 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
hypertension
Cardiac disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected17 at risk
EG0051 events1 affected17 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected27 at risk
EG0110 events0 affected4 at risk
Dental Issues
Gastrointestinal disorders
Systematic Assessment
This includes dental caries and endodontal abscess
EG0002 events1 affected11 at risk
EG0013 events3 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected17 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected27 at risk
EG0110 events0 affected4 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected17 at risk
EG0063 events2 affected17 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
Anxiety in MRI
Psychiatric disorders
Systematic Assessment
EG0002 events1 affected11 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected17 at risk
EG0051 events1 affected17 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected10 at risk
EG0082 events1 affected18 at risk
EG0091 events1 affected3 at risk
EG0102 events2 affected27 at risk
EG0110 events0 affected4 at risk
Skin irritation
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 events1 affected11 at risk
EG0012 events2 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected17 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected10 at risk
EG0081 events1 affected18 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
Back, shoulder or neck pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0002 events1 affected11 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected17 at risk
EG0051 events1 affected17 at risk
EG0061 events1 affected17 at risk
EG0071 events1 affected10 at risk
EG0083 events2 affected18 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
Headache
Nervous system disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected17 at risk
EG0062 events2 affected17 at risk
EG0071 events1 affected10 at risk
EG0083 events3 affected18 at risk
EG0090 events0 affected3 at risk
EG0108 events4 affected27 at risk
EG0110 events0 affected4 at risk
MRI Finding - Nervous System
Nervous system disorders
Systematic Assessment
Arachnoid cyst, Berry Aneurysm, Leukoencephalopathy, herniation of sella, 1.3 cm cyst, elevated signal hemibrain + pons, benign mass, cystic lesion, lesion, enlargement of pituitary gland, white matter signal abnormality
EG0001 events1 affected11 at risk
EG0012 events2 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0043 events3 affected17 at risk
EG0050 events0 affected17 at risk
EG0061 events1 affected17 at risk
EG0071 events1 affected10 at risk
EG0084 events4 affected18 at risk
EG0090 events0 affected3 at risk
EG0102 events2 affected27 at risk
EG0110 events0 affected4 at risk
Chest Pain
Cardiac disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected17 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected10 at risk
EG0081 events1 affected18 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
Nausea or vomiting
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected12 at risk
EG0021 events1 affected11 at risk
EG0032 events1 affected8 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected17 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected3 at risk
EG0102 events1 affected27 at risk
EG0110 events0 affected4 at risk
Injury
Injury, poisoning and procedural complications
Systematic Assessment
Fall, sprained knee, heel abrasion, bruising at IV insertion site
EG0000 events0 affected11 at risk
EG0012 events2 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected17 at risk
EG0061 events1 affected17 at risk
EG0071 events1 affected10 at risk
EG0083 events3 affected18 at risk
EG0090 events0 affected3 at risk
EG0103 events1 affected27 at risk
EG0110 events0 affected4 at risk
Upper Respiratory Infection
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0024 events3 affected11 at risk
EG0030 events0 affected8 at risk
EG0044 events2 affected17 at risk
EG0051 events1 affected17 at risk
EG0061 events1 affected17 at risk
EG0071 events1 affected10 at risk
EG0082 events2 affected18 at risk
EG0090 events0 affected3 at risk
EG0104 events4 affected27 at risk
EG0110 events0 affected4 at risk
Hemorrhoids
Surgical and medical procedures
Systematic Assessment
Hemorrhoidectomy
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected17 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
Chalazia
Eye disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected17 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
Abnormal EKG
Cardiac disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected17 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected10 at risk
EG0081 events1 affected18 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
Lightheaded/Dizzy
Nervous system disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected17 at risk
EG0062 events2 affected17 at risk
EG0070 events0 affected10 at risk
EG0082 events2 affected18 at risk
EG0090 events0 affected3 at risk
EG0102 events2 affected27 at risk
EG0110 events0 affected4 at risk
Dysesthesia/Parasthesia
Nervous system disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected17 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
Ear pain
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected17 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected27 at risk
EG0110 events0 affected4 at risk
Hemorrhoids
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected17 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected27 at risk
EG0110 events0 affected4 at risk
Hypoglycemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected17 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
Hypotension
Cardiac disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected17 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
Skin infection
Infections and infestations
Systematic Assessment
Foot fungus
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected17 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
Muscle aches
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected17 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
MRI Findings - Vascular
Vascular disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected17 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
MRI Findings - Respiratory
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0052 events2 affected17 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected3 at risk
EG0102 events2 affected27 at risk
EG0110 events0 affected4 at risk
Swelling of vein
Vascular disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected17 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
Other
Nervous system disorders
Systematic Assessment
Syncope, Tremor, Migraine
EG0000 events0 affected11 at risk
EG0012 events1 affected12 at risk
EG0020 events0 affected11 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected17 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected27 at risk
EG0110 events0 affected4 at risk
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
26.75
(21 to 32)
BG00443.59(18 to 54)
BG00534.29(20 to 49)
BG00631.53(18 to 46)
BG00734.10(19 to 48)
BG00835.55(19 to 55)
BG00929.66(18 to 44)
BG01033.48(22 to 53)
BG01126.5(18 to 37)
BG01232.59(18 to 55)
3
BG0043
BG0052
BG0062
BG0071
BG0087
BG0091
BG0108
BG0112
BG01235
Male
BG0009
BG0019
BG00210
BG0035
BG00414
BG00515
BG00615
BG0079
BG00811
BG0092
BG01019
BG0112
BG012120
0
BG0040
BG0051
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0123
Not Hispanic or Latino
BG00011
BG00111
BG00210
BG0038
BG00417
BG00516
BG00617
BG00710
BG00818
BG0093
BG01027
BG0114
BG012152
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
0
BG0041
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0121
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0060
BG0070
BG0080
BG0090
BG0101
BG0110
BG0122
Native Hawaiian or Other Pacific Islander
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0062
BG0070
BG0080
BG0090
BG0103
BG0111
BG0127
Black or African American
BG0002
BG0010
BG0021
BG0030
BG0040
BG0050
BG0060
BG0072
BG0081
BG0090
BG0100
BG0110
BG0126
White
BG0009
BG00110
BG0029
BG0038
BG00416
BG00515
BG00615
BG0077
BG00817
BG0093
BG01023
BG0113
BG012135
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
Unknown or Not Reported
BG0000
BG0011
BG0021
BG0030
BG0040
BG0051
BG0060
BG0071
BG0080
BG0090
BG0100
BG0110
BG0124
12.75
± 1.165
BG00414.12± 1.764
BG00514.35± 2.548
BG00614.35± 1.967
BG00712.8± 1.033
BG00813.33± 1.847
BG00912± 1
BG01017.19± 1.777
BG01114.67± 1.155
BG01214.28± 2.304
6
BG0040
BG0050
BG0060
BG0070
BG0089
BG0091
BG0100
BG0110
BG01227
ParticipantsBG00417
ParticipantsBG00517
ParticipantsBG00617
ParticipantsBG00710
ParticipantsBG00818
ParticipantsBG0093
ParticipantsBG01027
ParticipantsBG0114
ParticipantsBG012155
Title
Measurements
BG0008
BG0018
BG0027
BG0032
BG0040
BG0050
BG0060
BG0070
BG0089
BG0092
BG0100
BG0110
BG01236
15.88
± 4.88
BG00813.11± 3.31
BG00915.0± 2.65
BG01213.01± 3.73
Participants
BG004
0
ParticipantsBG0050
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG00818
ParticipantsBG0093
ParticipantsBG0100
ParticipantsBG0110
ParticipantsBG01263
Title
Measurements
BG00015.82± 8.34
BG00112.0± 4.41
BG00215.09± 7.91
BG00313.63± 3.54
BG00814.61± 3.96
BG00917.66± 6.81
BG01214.19± 5.6
18.25
± 14.76
BG00429.76± 10.14
BG00525.18± 12.86
BG00624.24± 11.55
BG00728.2± 10.35
BG0080± 0
BG0090± 0
BG0100.037± 0.192
BG0110.5± 1
BG01214.85± 15.54
44.09
± 62.20
BG00439.4± 45.3
BG00552.2± 78.6
BG00652.2± 57.5
BG00744.8± 51.2
BG0080± 0
BG0090± 0
BG0100.0357± 0.188
BG0110.333± 0.577
BG01226.01± 43.45
0
OG0040
OG0050
OG0060
OG0070
18
10.6
± 0.37
OG001
OG002
OG003
This analysis tested whether the dronabinol group had different PANSS Positive symptom scores compared to the placebo group adjusting for the SCZ only group. (The marijuana cigarette group was tested separately per our analytic plan.)
ANOVA
.62
Mean Difference (Final Values)
-1.2
Standard Error of the Mean
.62
2-Sided
95
-2.4
0.18
Superiority
18
15.2
± 0.56
OG002
OG003
This analysis tested whether the dronabinol group had different PANSS Positive negative scores compared to the placebo group adjusting for the SCZ only group. (The dronabinol group was tested separately per our analytic plan.)
ANOVA
0.39
Mean Difference (Final Values)
0.88
Standard Error of the Mean
1.0
2-Sided
95
-1.1
2.85
Superiority
17
OG00416
OG00516
OG00618
OG00727
25.0
± 4.97
OG00425.3± 6.1
OG00527.9± 4.5
OG00625.5± 8.6
OG00731.0± 3.3
18
14.31
± 4.72
OG001
OG002
OG003
This analysis tested whether the dronabinol group had different anxiety scores compared to the placebo group adjusting for the SCZ only group. (The dronabinol group was tested separately per our analytic plan.)
Regression, Linear
0.98
Mean Difference (Final Values)
-.88
Standard Error of the Mean
2.95
2-Sided
95
-5.87
5.70
Superiority
OG000
OG002
This analysis tested whether the marijuana cigarette group had different drug liking scores compared to the placebo group. (The dronabinol group was tested separately per our analytic plan.)