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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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Study participants received dronabinol (0, 120mg/day and 240mg/day) for 12 consecutive days in a randomized order. During each dronabinol maintenance period they were able to self-administer active or placebo cannabis using either a progressive ratio schedule or choice between cannabis and monetary alternative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose Dronabinol, High Dose Dronabinol, and placebo | Active Comparator | Participants were administered dronabinol (0 mg/day, 120mg/day and 240mg/day) for 12 days each in a random order |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dronabinol 120mg/day | Drug | Participants receive 40mg dronabinol 3 times daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Marijuana Self-administration - Progressive Ratio | Participants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) under a progressive ratio schedule. The number of progressive ratios completed (and thus, cannabis cigarettes consumed) is the primary study endpoint | 12-day Dronabinol maintenance period |
| Marijuana Self-administration - Drug Vs Money Choice | Participants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) in 5 discrete choices each day between one cannabis cigarette and $1. The number of cannabis cigarettes chosen (and subsequently self-administered) is the primary study endpoint | 12-day Dronabinol maintenance period |
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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 |
|---|---|---|---|---|---|---|
| Johns Hopkins University (Bayview Campus) | Baltimore | Maryland | 21224 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo, 120mg, 240mg | Participants received dronabinol for 12 days in the above order in a within-subject crossover |
| FG001 | 120mg, 240mg, Placebo | Participants received dronabinol for 12 days in the above order in a within-subject crossover |
| FG002 | 240mg, 120mg, Placebo | Participants received dronabinol for 12 days in the above order in a within-subject crossover |
| FG003 | 120mg, Placebo, 240mg | Participants received dronabinol for 12 days in the above order in a within-subject crossover |
| FG004 | 240mg, Placebo, 120mg | Participants received dronabinol for 12 days in the above order in a within-subject crossover |
| FG005 | Placebo, 240mg, 120mg | Participants received dronabinol for 12 days in the above order in a within-subject crossover |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants received dronabinol (PL, 120mg, 240mg/day) in a randomized within-subject crossover design |
| 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 | Marijuana Self-administration - Progressive Ratio | Participants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) under a progressive ratio schedule. The number of progressive ratios completed (and thus, cannabis cigarettes consumed) is the primary study endpoint | Posted | Mean | Standard Error | Progressive Ratios Completed | 12-day Dronabinol maintenance period |
|
3 months
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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 dronabinol maintenance | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Vandrey | Johns Hopkins University | 410-550-4036 | rvandrey@jhmi.edu |
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| ID | Term |
|---|---|
| D008385 | Marijuana Smoking |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D000074609 | Marijuana Use |
| D001519 | Behavior |
| D000073847 | Smoking, Non-Tobacco Products |
| D012907 | Smoking |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Participants receive placebo |
|
| Dronabinol 240mg/day | Drug | Participants receive 80mg dronabinol 3 times daily |
|
|
| Change in protocol |
|
| Protocol Violation |
|
| 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 |
|
| 240mg Dronabinol |
240mg/day (80mg tid) dronabinol maintenance period |
|
|
| Primary | Marijuana Self-administration - Drug Vs Money Choice | Participants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) in 5 discrete choices each day between one cannabis cigarette and $1. The number of cannabis cigarettes chosen (and subsequently self-administered) is the primary study endpoint | Posted | Mean | Standard Error | Cannabis Cigarettes Chosen | 12-day Dronabinol maintenance period |
|
|
|
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 120mg Dronabinol | 120mg (40mg tid) dronabinol maintenance | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | 240mg Dronabinol | 240mg (80mg tid) dronabinol maintenance | 0 | 25 | 0 | 25 | 0 | 25 |
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| D019966 |
| Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |