Marijuana Dependence
Conditions
Keywords
Marijuana dependence
Brief summary
This study will examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and smoked marijuana to determine if there are potential significant drug interactions before conducting outpatient studies.
Interventions
DRUGPlacebo
DRUGDronabinol
Sponsors
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Must be between 18 and 45 years of age * Must be in good general health and who meet DSM-IV diagnostic criteria for marijuana dependence * Must be seeking treatment at time of study entry * Must be able to understand and provide written informed consent * Must provide 1 marijuana positive urine specimen (\> 50 ng/mL) within the 28-day screening period * If female and of child bearing potential, agrees to use birth control. Exclusion Criteria: * Please contact site for more information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects. | Day 9 and 10 | Does dronabinol (when given during smoking of a marijuana cigarette) show changes in the number of participants that experience cardiovascular effects of smoked marijuana or has any other combination side effects. |
Countries
United States
Participant flow
Recruitment details
Recruitment was from October 31, 2006 to December 5, 2007. The study was conducted at the NIDA funded clinical pharmacology unit (CPU) at Uniformed Services University for the Health Sciences (USUHS).
Pre-assignment details
Volunteers meeting the maximum 28-day screening assessment period and eligibility criteria were enrolled into the Phase-1 clinical trial. The subjects had to meet the following criteria to be eligible: be non-treatment seeking, experienced marijuana users with dependence for the past year, and subjects that were in good general health.
Participants by arm
| Arm | Count |
|---|---|
| Dronabinol Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800. | 6 |
| Placebo Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800. | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Placebo | Dronabinol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 6 Participants | 12 Participants |
| Age, Continuous | 27.2 years STANDARD_DEVIATION 4.9 | 27.2 years STANDARD_DEVIATION 3.6 | 27.2 years STANDARD_DEVIATION 4.3 |
| Gender Female | 1 Participants | 2 Participants | 3 Participants |
| Gender Male | 5 Participants | 4 Participants | 9 Participants |
| Region of Enrollment United States | 6 participants | 6 participants | 12 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 6 | 1 / 6 |
| serious Total, serious adverse events | 1 / 6 | 0 / 6 |
Outcome results
Primary
Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects.
Does dronabinol (when given during smoking of a marijuana cigarette) show changes in the number of participants that experience cardiovascular effects of smoked marijuana or has any other combination side effects.
Time frame: Day 9 and 10
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dronabinol | Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects. | 6 participants |
| Placebo | Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects. | 6 participants |