The Effect of Prescription Medications in Marijuana Users

Phase 1

Completed

• Conditions: Marijuana Abuse
• Interventions: Drug: Dronabinol 30mg/day; Drug: Dronabinol 60mg/day; Drug: Dronabinol 120mg/day; Drug: Placebo

• Registration Number: NCT00893074
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-30
• Study First Submitted QC: 2009-05-04
• Study First Posted: 2009-05-05
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2017-04-18
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-02
• Last Update Submitted: 2017-08-02
• Results First Posted: 2017-08-03
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
0, 30, 60, and 120mg dronabinol	Dronabinol 120mg/day	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
0, 30, 60, and 120mg dronabinol	Dronabinol 30mg/day	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
0, 30, 60, and 120mg dronabinol	Dronabinol 60mg/day	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
0, 30, 60, and 120mg dronabinol	Placebo	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Heart Rate	Assessed on Day 5 of dronabinol maintenance	Heart rate measured after acute cannabis exposure

Trial Locations

Locations (1)

Behavioral Pharmacology Research Unit; 🇺🇸 Baltimore, Maryland, United States