Marijuana Smoking
Conditions
Keywords
marijuana, dronabinol, pharmacotherapy
Brief summary
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.
Interventions
Participants receive 40mg dronabinol 3 times daily
DRUGPlacebo
Participants receive placebo
DRUGDronabinol 240mg/day
Participants receive 80mg dronabinol 3 times daily
Sponsors
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Current use of marijuana * Able to give informed consent
Exclusion criteria
* Daily use of psychoactive medication * Current Axis I psychiatric disorder other than dependence on cannabis or nicotine, or abuse of drugs or alcohol * Women who are pregnant, breast feeding, or planning to become pregnant within the next 3 months * Those seeking treatment for cannabis-related problems or using cannabis under the guidance of a physician for a medical disorder * Uncontrolled or unstable cardiovascular disease * Allergy to sesame oil
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marijuana Self-administration - Progressive Ratio | 12-day Dronabinol maintenance period | 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 |
| Marijuana Self-administration - Drug Vs Money Choice | 12-day Dronabinol maintenance period | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants received dronabinol (PL, 120mg, 240mg/day) in a randomized within-subject crossover design | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Change in protocol | 3 | 0 | 0 | 0 | 3 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 25 years STANDARD_DEVIATION 5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
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
Time frame: 12-day Dronabinol maintenance period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Marijuana Self-administration - Drug Vs Money Choice | 3.5 Cannabis Cigarettes Chosen | Standard Error 0.6 |
| 120mg Dronabinol | Marijuana Self-administration - Drug Vs Money Choice | 2.3 Cannabis Cigarettes Chosen | Standard Error 0.4 |
| 240mg Dronabinol | Marijuana Self-administration - Drug Vs Money Choice | 2.5 Cannabis Cigarettes Chosen | Standard Error 0.5 |
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
Time frame: 12-day Dronabinol maintenance period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Marijuana Self-administration - Progressive Ratio | 5.2 Progressive Ratios Completed | Standard Error 0.2 |
| 120mg Dronabinol | Marijuana Self-administration - Progressive Ratio | 4.5 Progressive Ratios Completed | Standard Error 0.2 |
| 240mg Dronabinol | Marijuana Self-administration - Progressive Ratio | 4.4 Progressive Ratios Completed | Standard Error 0.2 |