The Effect of Prescription Medications in Marijuana Users

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Prescription Medications in Marijuana Users

Conditions
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Marijuana Abuse

Intervention / Treatment
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* Drug: Dronabinol 30mg/day
* Drug: Dronabinol 60mg/day
* Drug: Dronabinol 120mg/day
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 0, 30, 60, and 120mg dronabinol<br>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 | Drug: Dronabinol 30mg/day<br>* 10mg dronabinol administered 3x/day for 5 days<br>* Other names: Marinol;Drug: Dronabinol 60mg/day<br>* 20mg dronabinol administered 3x/day for 5 days<br>* Other names: Marinol;Drug: Dronabinol 120mg/day<br>* 40mg dronabinol administered 3x/day for 5 days<br>* Other names: Marinol;Drug: Placebo<br>* placebo dronabinol administered 3x/day for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | Heart rate measured after acute cannabis exposure | Assessed on Day 5 of dronabinol maintenance | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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withdrawal, acute effects, cognitive performance, Marijuana Use, Marijuana Abstinence