Comparing the Effects of Smoked and Oral Marijuana in Individuals With HIV/AIDS

Phase 1

Completed

• Conditions: HIV Infections

• Registration Number: NCT00079560
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

Smoked marijuana (MJ) and dronabinol (also known as THC or by the trade name Marinol) are used to increase appetite, food intake, and weight in patients with HIV who experience unintended weight loss. This study will compare the effects of MJ and Marinol use in marijuana smokers who are HIV infected.

Detailed Description

Little is known about the efficacy and tolerability of oral THC versus smoked MJ in a clinically relevant population. Additionally, it is not clear how THC's effects vary as a function of the duration of treatment or the patient's current patterns of smoked MJ use. This study directly compares 3 doses of smoked marijuana and 3 doses of Marinol across a range of behavioral measures in HIV infected marijuana smokers.

Outcome measures will include analysis of food intake, body composition, mood, physical symptoms (e.g., nausea, stomach pain), psychomotor task performance, and sleep.

Study Timeline

• Study Start: 2001-12
• Study First Submitted: 2004-03-09
• Study First Submitted QC: 2004-03-09
• Study First Posted: 2004-03-10
• Primary Completion: 2004-08
• Study Completion: 2005-08
• Status Verified: 2008-10
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
daily caloric intake	daily measure of colories

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States