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| Sponsored by: |
National Institute on Drug Abuse (NIDA) |
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00079560 |
Purpose
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.
| Condition | Intervention | Phase |
|
HIV Infections |
Drug: dronabinol |
Phase I Phase II |
| MedlinePlus related topics: | AIDS |
| ChemIDplus related topics: | Tetrahydrocannabinol Cannabis GW-1000 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | THC and Marijuana--Effects in Individuals With HIV/AIDS |
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2001 |
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.
Eligibility
| Ages Eligible for Study: | 21 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Contacts and Locations| United States, New York | |||||
| New York State Psychiatric Institute | Recruiting | ||||
| New York, New York, United States, 10032 | |||||
| Contact: Margaret Haney, PhD 212-543-5175 MH235@columbia.edu | |||||
| Principal Investigator: | Margaret Haney, PhD | New York State Psychiatric Institute |
More Information
| Study ID Numbers: | 1 R01 DA12698-01A1 |
| First Received: | March 9, 2004 |
| Last Updated: | February 28, 2006 |
| ClinicalTrials.gov Identifier: | NCT00079560 |
| Health Authority: | United States: Food and Drug Administration |
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