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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA025044 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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A subset of heavy marijuana users have trouble quitting marijuana use and the number of those seeking treatment for problems related to marijuana is increasing. The purpose of this research study is to investigate whether dronabinol can reduce withdrawal effects associated with stopping marijuana use, if dronabinol can reduce the rewarding effects of smoked marijuana, and whether there are any cognitive performance deficits associated with dronabinol doses that produce such effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0, 30, 60, and 120mg dronabinol | Other | 0, 30, 60, and 120mf dronabinol was administered in a randomized within-subjects crossover study to compare the medication dose effects of cannabis withdrawal, cognitive performance, and response to acute cannabis dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dronabinol 30mg/day | Drug | 10mg dronabinol administered 3x/day for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Effect of Marijuana Withdrawal | Total withdrawal based on a composite score of the Marijuana Withdrawal Checklist (range 0-32; higher scores indicate greater withdrawal). | Day 5 of the Dronabinol abstinence period |
| Subjective "Drug Effect" After Smoked Marijuana | Subjective drug effects on a 100mm point Visual Analog Scale reported following acute cannabis dose administration during dronabinol maintenance, scale ranging 0-100, with 0 being no effect and 100 being maximum effect | Day 5 of the Dronabinol abstinence period |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | Heart rate measured after acute cannabis exposure | Assessed on Day 5 of dronabinol maintenance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Vandrey, Ph.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Behavioral Pharmacology Research Unit | Baltimore | Maryland | 21224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22921474 | Result | Vandrey R, Stitzer ML, Mintzer MZ, Huestis MA, Murray JA, Lee D. The dose effects of short-term dronabinol (oral THC) maintenance in daily cannabis users. Drug Alcohol Depend. 2013 Feb 1;128(1-2):64-70. doi: 10.1016/j.drugalcdep.2012.08.001. Epub 2012 Aug 22. | |
| 29689485 | Derived | Schlienz NJ, Lee DC, Stitzer ML, Vandrey R. The effect of high-dose dronabinol (oral THC) maintenance on cannabis self-administration. Drug Alcohol Depend. 2018 Jun 1;187:254-260. doi: 10.1016/j.drugalcdep.2018.02.022. Epub 2018 Apr 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0, 30, 60, and 120mg Dronabinol | 0, 30, 60, and 120mg Dronabinol administered for 5 consecutive days in a double blind, placebo controlled study, with dose administered in a random order to the same study participants |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Participant | Participants who received active drug as part of the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Peak Effect of Marijuana Withdrawal | Total withdrawal based on a composite score of the Marijuana Withdrawal Checklist (range 0-32; higher scores indicate greater withdrawal). | Posted | Mean | Standard Error | units on a scale | Day 5 of the Dronabinol abstinence period |
|
51 days
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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 | Placebo | Placebo maintenance | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Vandrey, PhD | Johns Hopkins University | 410-550-4036 | rvandrey@jhmi.edu |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| D000074609 | Marijuana Use |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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Within-subjects cross-over evaluation of 0, 30, 60, and 120mg dronabinol per day on withdrawal, cognitive performance, and response to acute cannabis exposure
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Dronbinol doses were double blind and placebo controlled
| Dronabinol 60mg/day | Drug | 20mg dronabinol administered 3x/day for 5 days |
|
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| Dronabinol 120mg/day | Drug | 40mg dronabinol administered 3x/day for 5 days |
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| Placebo | Drug | placebo dronabinol administered 3x/day for 5 days |
|
| 25220020 | Derived | Lee D, Vandrey R, Mendu DR, Murray JA, Barnes AJ, Huestis MA. Oral fluid cannabinoids in chronic frequent cannabis smokers during ad libitum cannabis smoking. Drug Test Anal. 2015 Jun;7(6):494-501. doi: 10.1002/dta.1718. Epub 2014 Sep 14. |
| 23831756 | Derived | Lee D, Vandrey R, Milman G, Bergamaschi M, Mendu DR, Murray JA, Barnes AJ, Huestis MA. Oral fluid/plasma cannabinoid ratios following controlled oral THC and smoked cannabis administration. Anal Bioanal Chem. 2013 Sep;405(23):7269-79. doi: 10.1007/s00216-013-7159-8. Epub 2013 Jul 6. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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60mg daily dronabinol (20mg tid) administered for 5 days
| OG003 | 120mg Dronabinol | 120mg daily dronabinol (40mg tid) administered for 5 days |
|
|
| Primary | Subjective "Drug Effect" After Smoked Marijuana | Subjective drug effects on a 100mm point Visual Analog Scale reported following acute cannabis dose administration during dronabinol maintenance, scale ranging 0-100, with 0 being no effect and 100 being maximum effect | Posted | Mean | Standard Error | mm of subjective drug effect | Day 5 of the Dronabinol abstinence period |
|
|
|
| Secondary | Heart Rate | Heart rate measured after acute cannabis exposure | Posted | Mean | Standard Error | beats per minutes | Assessed on Day 5 of dronabinol maintenance |
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| 24 |
| 0 |
| 24 |
| 7 |
| 24 |
| EG001 | 30mg | 30mg dronabinol maintenance | 0 | 24 | 0 | 24 | 7 | 24 |
| EG002 | 60mg | 60mg dronabinol maintenance | 0 | 24 | 0 | 24 | 4 | 24 |
| EG003 | 120mg | 120mg dronabinol maintenance | 0 | 24 | 0 | 24 | 7 | 24 |
| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Dry Mouth | General disorders | Systematic Assessment |
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