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| ID | Type | Description | Link |
|---|---|---|---|
| R42DA043977 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study will assess effects of tetrahydrocannabinol (THC) and THC + alcohol in marijuana users on prefrontal brain activity, using functional near-infrared spectroscopy (fNIRS) during resting state and during memory task performance. Participants will complete fNIRS testing 120 minutes following THC or identical placebo (Phase 2A), or THC/ethanol, THC/placebo ethanol, placebo THC/ethanol, and placebo THC/placebo ethanol (Phase 2B), and oxygenated hemoglobin (HbO) concentration will be measured.
This study will assess the effects of THC intoxication using dronabinol (synthetic THC) on the oxyhemoglobin (HbO) signal during resting state and task-based activation in the prefrontal cortex (PFC) and resting state connectivity, as well as on neurocognitive task performance and correlations between these measurements and clinical signs of intoxication. Participants will be 150 adults who use marijuana at least monthly (aged 18-55) will be recruited to participate in this study. Participants will be given up to 80 mg of dronabinol, an FDA-approved synthetic form of THC that is used to treat loss of appetite that causes weight loss in people with AIDS. THC is the principle psychoactive drug in marijuana. The study will be conducted in regular cannabis users who present at their first study visit with a positive urine screen for THC metabolites.
Phase 2A. Investigate the effect of THC on fNIRS brain signature and its association with self-reported intoxication, laboratory measures of impairment, and the gold-standard behavioral field test of driving impairment used by law enforcement, the primary classifier.
Phase 2B. Examine potential interaction following co-administration of THC with oral ethanol exposure in healthy volunteers. Phase II is a randomized, double-blind, placebo-controlled, 2 by 2 crossover study of effect of dronabinol, ethanol, and combined dronabinol and ethanol on brain activation and connectivity as measured by fNIRS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 2A | Experimental | In a double-blind placebo-controlled, random order cross-over study of single dose dronabinol, participants received dronabinol or identical placebo on two separate study visits in randomized order. |
|
| Phase 2B | Experimental | In a randomized, double-blind, 4-treatment, 4-period, crossover study with THC or placebo administration and ethanol or placebo administration, participants were randomly assigned to 1 of 4 sequences and received each of the following treatments: placebo dronabinol + placebo ethanol, placebo dronabinol + ethanol, dronabinol + placebo ethanol, & dronabinol + ethanol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dronabinol | Drug | Dronabinol at physician determined doses of 10-80mg designed to produce intoxication. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task. | Subjects completed the N-back task before and after receiving a combination of active dronabinol or placebo dronabinol and active ethanol or placebo ethanol. During the task, the fNIRS device was used to capture change in concentration of oxygenated hemoglobin to assess prefrontal brain activity. Outcomes reflect average change from baseline in HbO concentration over pre-dose scan and average change from baseline in HbO concentration over post-dose scan (expected peak intoxication). | The first Nback scan session was run before dosing (t ≈ -35min). Drug was administered (t = 0min). The second Nback scan session was run at the time of expected peak pharmacokinetic effect (t ≈ 100min). Each scan session was six minutes in duration. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans During Resting State. | Subjects completed resting-state fNIRS scans before and after receiving a combination of active dronabinol or placebo dronabinol and active ethanol or placebo ethanol. During the task, the fNIRS device was used to capture concentration of oxygenated hemoglobin to assess prefrontal brain activity. Outcomes reflect average change from baseline in HbO concentration over pre-dose scan and average change from baseline in HbO concentration over post-dose scan (expected peak intoxication). |
Inclusion Criteria General
Men and women aged 18-55 years, inclusive; (for Phase 2B: men and women aged 21-55 years, inclusive)
Competent and willing to provide written informed consent;
Able to communicate in English language.
Regular, at least monthly, marijuana use, confirmed by positive urine screen for THC
Additional Inclusion Criteria For Phase 2B:
Past consumption of at least two alcoholic beverages in one occasion.
Past co-consumption of alcohol and THC at least once in lifetime with no serious adverse effects.
Weigh more than 100 lbs.
Exclusion Criteria:
General (Phase 2A, 2B 3)
Any unstable, serious medical illness, or cardiovascular disease or events.
New or unstable psychiatric symptoms, schizophrenia, or bipolar I disorder,
Diabetes, cirrhosis, renal failure, Hepatitis C, HIV,
History of syncope without an identified situational stressor, migraines >1x/month, head injury with prolonged unconsciousness (> 24 hours);
Allergy to sesame oil (contained in Marinol pills) or Marinol capsules
Daily use of benzodiazepines or barbiturates, antihistamines, atropine, scopolamine, or other strong anticholinergic agents;
Current pregnancy or lactation, or trying to become pregnant (confirmed by urine pregnancy test)
In the opinion of the investigator, not able to safely participate in this study.
Additional Exclusion Criteria For Phase 2B:
Currently seeking treatment, in treatment, or in recovery from an alcohol use disorder.
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| Name | Affiliation | Role |
|---|---|---|
| A. Eden Evins, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Jodi M Gilman, PhD | Massachusetts General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Addiction Medicine, Massachusetts General Hospital, Dept. of Psychiatry | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41615687 | Derived | Berchansky M, Evins AE, Evohr B, Himmelsbach Z, Pachas GN, Karunakaran KD, Laufer Goldshtein B, Ozana N, Gilman JM. Detection of Delta9-Tetrahydrocannabinol Impairment Using Resting-State Functional Near-Infrared Spectroscopy: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2556647. doi: 10.1001/jamanetworkopen.2025.56647. | |
| 38714786 | Derived | Karunakaran KD, Pascale M, Ozana N, Potter K, Pachas GN, Evins AE, Gilman JM. Intoxication due to Delta9-tetrahydrocannabinol is characterized by disrupted prefrontal cortex activity. Neuropsychopharmacology. 2024 Aug;49(9):1481-1490. doi: 10.1038/s41386-024-01876-5. Epub 2024 May 7. |
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Individual participant data (IPD) will not be available
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A screening visit took place before randomization. After randomization, phase 2A completed two visits and phase 2B completed four visits.
Washout achieved with at least one week between visits. Participant dropout affected by the COVID-19 pandemic.
Due to character limit, sequences coded as follows:
A: Placebo Dronabinol
B: Dronabinol
C: Placebo Dronabinol & Placebo Ethanol
D: Dronabinol & Placebo Ethanol
E: Placebo Dronabinol & Ethanol
F: Dronabinol & Ethanol
Participants were recruited by study staff at the MGH Center for Addiction Medicine through advertising by email, web and bulletin board announcements posted within the local site network community.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 2A: AB | Placebo then Dronabinol Over two visits, Phase 2A participants were assigned in a random order to a single dose of either dronabinol and placebo. Visits were approximately one week apart. |
| FG001 | Phase 2A: BA | Dronabinol then Placebo |
| FG002 | Phase 2B: CDEF | Placebo Dronabinol and Placebo Ethanol, then Dronabinol and Placebo Ethanol, then Placebo Dronabinol and Ethanol, then Dronabinol and Ethanol Phase 2B was a randomized, double-blind, 4-treatment, 4-period, crossover study with THC or placebo administration and ethanol or placebo administration. Over four visits participants were assigned in a random order to each of dronabinol and ethanol, dronabinol and placebo ethanol, placebo dronabinol and ethanol, or placebo dronabinol and placebo ethanol. Visits were approximately one week apart. |
| FG003 | Phase 2B: CDFE | Placebo Dronabinol and Placebo Ethanol, then Dronabinol and Placebo Ethanol, then Dronabinol and Ethanol, then Placebo Dronabinol and Ethanol |
| FG004 | Phase 2B: CEDF | Placebo Dronabinol and Placebo Ethanol, then Placebo Dronabinol and Ethanol, then Dronabinol and Placebo Ethanol, then Dronabinol and Ethanol |
| FG005 | Phase 2B: CEFD | Placebo Dronabinol and Placebo Ethanol, then Placebo Dronabinol and Ethanol, then Dronabinol and Ethanol, then Dronabinol and Placebo Ethanol |
| FG006 | Phase 2B: CFDE | Placebo Dronabinol and Placebo Ethanol, then Dronabinol and Ethanol, then Dronabinol and Placebo Ethanol, then Placebo Dronabinol and Ethanol |
| FG007 | Phase 2B: CFED | Placebo Dronabinol and Placebo Ethanol, then Dronabinol and Ethanol, then Placebo Dronabinol and Ethanol, then Dronabinol and Placebo Ethanol |
| FG008 | Phase 2B: DCEF | Dronabinol and Placebo Ethanol, then Placebo Dronabinol and Placebo Ethanol, then Placebo Dronabinol and Ethanol, then Dronabinol and Ethanol |
| FG009 | Phase 2B: DCFE | Dronabinol and Placebo Ethanol, then Placebo Dronabinol and Placebo Ethanol, then Dronabinol and Ethanol, then Placebo Dronabinol and Ethanol |
| FG010 | Phase 2B: DECF | Dronabinol and Placebo Ethanol, then Placebo Dronabinol and Ethanol, then Placebo Dronabinol and Placebo Ethanol, then Dronabinol and Ethanol |
| FG011 | Phase 2B: DEFC | Dronabinol and Placebo Ethanol, then Placebo Dronabinol and Ethanol, then Dronabinol and Ethanol, then Placebo Dronabinol and Placebo Ethanol |
| FG012 | Phase 2B: DFCE | Dronabinol and Placebo Ethanol, then Dronabinol and Ethanol, then Placebo Dronabinol and Placebo Ethanol, then Placebo Dronabinol and Ethanol |
| FG013 | Phase 2B: DFEC | Dronabinol and Placebo Ethanol, then Dronabinol and Ethanol, then Placebo Dronabinol and Ethanol, then Placebo Dronabinol and Placebo Ethanol |
| FG014 | Phase 2B: ECDF | Placebo Dronabinol and Ethanol, then Placebo Dronabinol and Placebo Ethanol, then Dronabinol and Placebo Ethanol, then Dronabinol and Ethanol |
| FG015 | Phase 2B: ECFD | Placebo Dronabinol and Ethanol, then Placebo Dronabinol and Placebo Ethanol, then Dronabinol and Ethanol, then Dronabinol and Placebo Ethanol |
| FG016 | Phase 2B: EDCF | Placebo Dronabinol and Ethanol, then Dronabinol and Placebo Ethanol, then Placebo Dronabinol and Placebo Ethanol, then Dronabinol and Ethanol |
| FG017 | Phase 2B: EDFC | Placebo Dronabinol and Ethanol, then Dronabinol and Placebo Ethanol, then Dronabinol and Ethanol, then Placebo Dronabinol and Placebo Ethanol |
| FG018 | Phase 2B: EFCD | Placebo Dronabinol and Ethanol, then Dronabinol and Ethanol, then Placebo Dronabinol and Placebo Ethanol, then Dronabinol and Placebo Ethanol |
| FG019 | Phase 2B: EFDC | Placebo Dronabinol and Ethanol, then Dronabinol and Ethanol, then Dronabinol and Placebo Ethanol, then Placebo Dronabinol and Placebo Ethanol |
| FG020 | Phase 2B: FCDE | Dronabinol and Ethanol, then Placebo Dronabinol and Placebo Ethanol, then Dronabinol and Placebo Ethanol, then Placebo Dronabinol and Ethanol |
| FG021 | Phase 2B: FCED | Dronabinol and Ethanol, then Placebo Dronabinol and Placebo Ethanol, then Placebo Dronabinol and Ethanol, then Dronabinol and Placebo Ethanol |
| FG022 | Phase 2B: FDCE | Dronabinol and Ethanol, then Dronabinol and Placebo Ethanol, then Placebo Dronabinol and Placebo Ethanol, then Placebo Dronabinol and Ethanol |
| FG023 | Phase 2B: FDEC | Dronabinol and Ethanol, then Dronabinol and Placebo Ethanol, then Placebo Dronabinol and Ethanol, then Placebo Dronabinol and Placebo Ethanol |
| FG024 | Phase 2B: FECD | Dronabinol and Ethanol, then Placebo Dronabinol and Ethanol, then Placebo Dronabinol and Placebo Ethanol, then Dronabinol and Placebo Ethanol |
| FG025 | Phase 2B: FEDC | Dronabinol and Ethanol, then Placebo Dronabinol and Ethanol, then Dronabinol and Placebo Ethanol, then Placebo Dronabinol and Placebo Ethanol |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 2A - Total Sample | In a double-blind placebo-controlled, random order cross-over study of single dose dronabinol, participants received dronabinol or identical placebo on two separate study visits in randomized order. |
| BG001 | Phase 2B - Total Sample |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task. | Subjects completed the N-back task before and after receiving a combination of active dronabinol or placebo dronabinol and active ethanol or placebo ethanol. During the task, the fNIRS device was used to capture change in concentration of oxygenated hemoglobin to assess prefrontal brain activity. Outcomes reflect average change from baseline in HbO concentration over pre-dose scan and average change from baseline in HbO concentration over post-dose scan (expected peak intoxication). | Note: The Participant Flow lists Phase 2A by randomization sequence (recommended for crossover studies). Phase 2A: Includes participants that completed scans after receiving dronabinol (119 subjects) and after placebo (115 subjects) Phase 2B: Incudes participants that completed scans after receiving dronabinol + ethanol (30 subjects), dronabinol + placebo ethanol (31 subjects), placebo dronabinol + ethanol (28 subjects) and placebo dronabinol + placebo ethanol (34 subjects) | Posted | Mean | Standard Deviation | Δ mol/L | The first Nback scan session was run before dosing (t ≈ -35min). Drug was administered (t = 0min). The second Nback scan session was run at the time of expected peak pharmacokinetic effect (t ≈ 100min). Each scan session was six minutes in duration. |
Participant enrollment to study completion, an average of 3 weeks for Phase 2A and 6 weeks for Phase 2B
Any observed or reported adverse event that occurred during the study visit was recorded and monitored by trained study staff. Additionally, at the beginning of each study visit, participants were asked if there were any changes to their physical or mental health since their last study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 2A: Dronabinol Only | This group includes the Phase 2A visit at which dronabinol was administered. Phase 2A was a double-blind placebo-controlled, random order cross-over study in which participants received dronabinol or identical placebo on two separate study visits, one week apart. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
After reviewing and updating the study record to appropriately reflect the approved protocol, it was determined that the entry for Study Phase is best represented as N/A, rather than Phase 4, as the purpose of the study is NOT to investigate the safety or efficacy of the drug. This study seeks to use dronabinol only to probe and describe brain physiology. The change from Phase 4 to N/A more accurately and reflects the IRB approved protocol, and the aims of the grant that funds the research.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jodi Gilman | Massachusetts General Hospital | 617-643-7293 | jgilman1@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 3, 2020 | Jun 3, 2022 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 29, 2022 | May 2, 2022 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 15, 2022 | Apr 6, 2022 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D000435 | Alcoholic Intoxication |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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In Phase 2A, a double-blind placebo-controlled, random order cross-over study of single dose dronabinol, participants received dronabinol or identical placebo on two separate study visits in randomized order.
In Phase 2B, a randomized, double-blind, 4-treatment, 4-period, crossover study with THC or placebo administration and ethanol or placebo administration, participants were randomly assigned to 1 of 24 sequences of each of the following treatments: placebo dronabinol and placebo ethanol, placebo dronabinol and ethanol, dronabinol and placebo ethanol, and dronabinol and ethanol.
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Subjects will be randomly assigned to one of the possible orders according to a randomization schedule generated by the study staff using a random number generator and computer program. The Massachusetts General Hospital (MGH) research pharmacy will generate a blinded randomization code for order of dosing and will dispense blinded drug in the dose ordered and identical placebo for use on separate study days. Ethanol or placebo drink will be prepared by a member of the research unit staff not otherwise associated with study visits.
| Ethanol | Drug | Oral Ethanol, dosed to obtain a breath alcohol concentration (BrAC) of approximately 0.05 BrAC (equal to 1-2 standard drinks). |
|
|
| Placebo dronabinol | Drug | Identical in appearance to active dronabinol (overencapsulation of both active and placebo dronabinol) |
|
|
| Placebo ethanol | Drug | Placebo ethanol will consist of diet soda used in the active ethanol condition with 0.25ml ethanol floated on top to provide the odor of ethanol and blind the study drug. |
|
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| The first resting-state scan session was run before dosing (t ≈ -45min). Drug was administered (t = 0min). The second resting-state scan session was run at the time of expected peak high (t ≈ 90min). Each scan session was six minutes in duration. |
| 34999737 | Derived | Gilman JM, Schmitt WA, Potter K, Kendzior B, Pachas GN, Hickey S, Makary M, Huestis MA, Evins AE. Identification of ∆9-tetrahydrocannabinol (THC) impairment using functional brain imaging. Neuropsychopharmacology. 2022 Mar;47(4):944-952. doi: 10.1038/s41386-021-01259-0. Epub 2022 Jan 8. |
| Physician Decision |
|
| Lost to Follow-up |
|
In a randomized, double-blind, 4-treatment, 4-period, crossover study with THC or placebo administration and ethanol or placebo administration, participants were randomly assigned to 1 of 4 sequences and received each of the following treatments: placebo dronabinol + placebo ethanol, placebo dronabinol + ethanol, dronabinol + placebo ethanol, & dronabinol + ethanol. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
|
| Other Pre-specified | Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans During Resting State. | Subjects completed resting-state fNIRS scans before and after receiving a combination of active dronabinol or placebo dronabinol and active ethanol or placebo ethanol. During the task, the fNIRS device was used to capture concentration of oxygenated hemoglobin to assess prefrontal brain activity. Outcomes reflect average change from baseline in HbO concentration over pre-dose scan and average change from baseline in HbO concentration over post-dose scan (expected peak intoxication). | Note: The Participant Flow lists Phase 2A by randomization sequence (recommended for crossover studies). Phase 2A: Includes participants that completed scans after receiving dronabinol (119 subjects) and after placebo (115 subjects) Phase 2B: Incudes participants that completed scans after receiving dronabinol + ethanol (30 subjects), dronabinol + placebo ethanol (31 subjects), placebo dronabinol + ethanol (28 subjects) and placebo dronabinol + placebo ethanol (34 subjects) | Posted | Mean | Standard Deviation | Δ mol/L | The first resting-state scan session was run before dosing (t ≈ -45min). Drug was administered (t = 0min). The second resting-state scan session was run at the time of expected peak high (t ≈ 90min). Each scan session was six minutes in duration. |
|
|
|
|
| 0 |
| 128 |
| 0 |
| 128 |
| 13 |
| 128 |
| EG001 | Phase 2A: Placebo Dronabinol Only | This group includes the Phase 2A visit at which placebo dronabinol was administered. Phase 2A was a double-blind placebo-controlled, random order cross-over study in which participants received dronabinol or identical placebo on two separate study visits, one week apart. | 0 | 126 | 0 | 126 | 6 | 126 |
| EG002 | Phase 2B: Dronabinol and Ethanol | Phase 2B was a randomized, double-blind, 4-treatment, 4-period, crossover study with THC or placebo administration and ethanol or placebo administration. Over four visits participants were assigned in a random order to each of dronabinol and ethanol, dronabinol and placebo ethanol, placebo dronabinol and ethanol, or placebo dronabinol and placebo ethanol. Visits were approximately one week apart. At this visit, participants received dronabinol and ethanol. | 0 | 39 | 0 | 39 | 7 | 39 |
| EG003 | Phase 2B: Dronabinol and Placebo Ethanol | Phase 2B was a randomized, double-blind, 4-treatment, 4-period, crossover study with THC or placebo administration and ethanol or placebo administration. Over four visits participants were assigned in a random order to each of dronabinol and ethanol, dronabinol and placebo ethanol, placebo dronabinol and ethanol, or placebo dronabinol and placebo ethanol. Visits were approximately one week apart. At this visit, participants received dronabinol and placebo ethanol. | 0 | 39 | 0 | 39 | 12 | 39 |
| EG004 | Phase 2B: Placebo Dronabinol and Ethanol | Phase 2B was a randomized, double-blind, 4-treatment, 4-period, crossover study with THC or placebo administration and ethanol or placebo administration. Over four visits participants were assigned in a random order to each of dronabinol and ethanol, dronabinol and placebo ethanol, placebo dronabinol and ethanol, or placebo dronabinol and placebo ethanol. Visits were approximately one week apart. At this visit, participants received placebo dronabinol and ethanol. | 0 | 32 | 0 | 32 | 3 | 32 |
| EG005 | Phase 2B: Placebo Dronabinol and Placebo Ethanol | Phase 2B was a randomized, double-blind, 4-treatment, 4-period, crossover study with THC or placebo administration and ethanol or placebo administration. Over four visits participants were assigned in a random order to each of dronabinol and ethanol, dronabinol and placebo ethanol, placebo dronabinol and ethanol, or placebo dronabinol and placebo ethanol. Visits were approximately one week apart. At this visit, participants received placebo dronabinol and placebo ethanol. | 0 | 38 | 0 | 38 | 4 | 38 |
| Cold | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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| D000438 |
| Alcohols |
| Peak |
|
Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for dronabinol conditions (positive values denote higher HbO levels for post-dronabinol scans). |
| Superiority |
| The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with ethanol (i.e., a main effect for ethanol dose), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order. | Regression, Linear | Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times. | 0.94 | The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p<0.05. | Mean Difference (Final Values) | -0.176 | Standard Error of the Mean | 0.210 | 2-Sided | 95 | -0.588 | 0.237 | Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for ethanol conditions (positive values denote higher HbO levels for post-ethanol scans). | Superiority |
| The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with both dronabinol and ethanol (i.e., the interaction between dronabinol and ethanol doses), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order. | Regression, Linear | Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times. | 0.94 | The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p<0.05. | Mean Difference (Final Values) | 0.187 | Standard Error of the Mean | 0.276 | 2-Sided | 95 | -0.354 | 0.728 | Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for the dronabinol + ethanol condition (positive values denote higher HbO levels for post-dronabinol+ethanol scans). | Superiority |