Comparing the Effects of Smoked and Oral Marijuana in Individuals With HIV/AIDS
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|ClinicalTrials.gov Identifier: NCT00079560|
Recruitment Status : Completed
First Posted : March 10, 2004
Last Update Posted : January 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: dronabinol||Phase 1 Phase 2|
Expanded Access : National Institute on Drug Abuse (NIDA) has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||THC and Marijuana--Effects in Individuals With HIV/AIDS|
|Study Start Date :||December 2001|
|Actual Primary Completion Date :||August 2004|
|Actual Study Completion Date :||August 2005|
- Drug: dronabinol
dronabinol to prevent development of marijuana withdrawal
- daily caloric intake [ Time Frame: daily measure of colories ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00079560
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Margaret Haney, PhD||New York State Psychiatric Institute|