Marijuana Abuse
Conditions
Keywords
withdrawal, acute effects, cognitive performance, Marijuana Use, Marijuana Abstinence
Brief summary
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.
Interventions
DRUGDronabinol 30mg/day
10mg dronabinol administered 3x/day for 5 days
DRUGDronabinol 60mg/day
20mg dronabinol administered 3x/day for 5 days
40mg dronabinol administered 3x/day for 5 days
DRUGPlacebo
placebo dronabinol administered 3x/day for 5 days
Sponsors
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Dronbinol doses were double blind and placebo controlled
Intervention model description
Within-subjects cross-over evaluation of 0, 30, 60, and 120mg dronabinol per day on withdrawal, cognitive performance, and response to acute cannabis exposure
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* current use of marijuana * able to give informed consent
Exclusion criteria
* dependence on drug other than marijuana * pregnant, breast feeding, or planning to become pregnant within the next 3 months * currently seeking treatment for cannabis-related problems or otherwise trying to reduce use * use of cannabis under the guidance of a physician for a medical disorder * unstable or uncontrolled cardiovascular disease (e.g., hypertension, angina) * allergy to study medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Effect of Marijuana Withdrawal | Day 5 of the Dronabinol abstinence period | Total withdrawal based on a composite score of the Marijuana Withdrawal Checklist (range 0-32; higher scores indicate greater withdrawal). |
| Subjective Drug Effect After Smoked Marijuana | Day 5 of the Dronabinol abstinence period | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | Assessed on Day 5 of dronabinol maintenance | Heart rate measured after acute cannabis exposure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Participant Participants who received active drug as part of the study | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Study Participant |
|---|---|
| Age, Continuous | 32 years STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 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 | 22 Participants |
| Race (NIH/OMB) More than one race | 0 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 | 2 Participants |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 7 / 24 | 7 / 24 | 4 / 24 | 7 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 |
Outcome results
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).
Time frame: Day 5 of the Dronabinol abstinence period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Peak Effect of Marijuana Withdrawal | 4.6 units on a scale | Standard Error 0.9 |
| 30mg Dronabinol | Peak Effect of Marijuana Withdrawal | 4.1 units on a scale | Standard Error 0.9 |
| 60mg Dronabinol | Peak Effect of Marijuana Withdrawal | 2.9 units on a scale | Standard Error 0.7 |
| 120mg Dronabinol | Peak Effect of Marijuana Withdrawal | 1.7 units on a scale | Standard Error 0.4 |
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
Time frame: Day 5 of the Dronabinol abstinence period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Subjective Drug Effect After Smoked Marijuana | 23 mm of subjective drug effect | Standard Error 3 |
| 30mg Dronabinol | Subjective Drug Effect After Smoked Marijuana | 28 mm of subjective drug effect | Standard Error 3 |
| 60mg Dronabinol | Subjective Drug Effect After Smoked Marijuana | 24 mm of subjective drug effect | Standard Error 3 |
| 120mg Dronabinol | Subjective Drug Effect After Smoked Marijuana | 29 mm of subjective drug effect | Standard Error 3 |
Secondary
Heart Rate
Heart rate measured after acute cannabis exposure
Time frame: Assessed on Day 5 of dronabinol maintenance
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Heart Rate | 88 beats per minutes | Standard Error 2 |
| 30mg Dronabinol | Heart Rate | 85 beats per minutes | Standard Error 2 |
| 60mg Dronabinol | Heart Rate | 80 beats per minutes | Standard Error 1 |
| 120mg Dronabinol | Heart Rate | 76 beats per minutes | Standard Error 1 |