Effects of Dronabinol (Oral THC) on Cannabis Use

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Dronabinol (Oral THC) on Cannabis Use

Conditions
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Marijuana Smoking

Intervention / Treatment
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* Drug: Dronabinol 120mg/day
* Drug: Placebo
* Drug: Dronabinol 240mg/day


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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low Dose Dronabinol, High Dose Dronabinol, and placebo<br>Participants were administered dronabinol (0 mg/day, 120mg/day and 240mg/day) for 12 days each in a random order | Drug: Dronabinol 120mg/day<br>* Participants receive 40mg dronabinol 3 times daily<br>* Other names: THC;Drug: Placebo<br>* Participants receive placebo<br>Drug: Dronabinol 240mg/day<br>* Participants receive 80mg dronabinol 3 times daily<br>* Other names: THC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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marijuana, dronabinol, pharmacotherapy