Comparing the Effects of Smoked and Oral Marijuana in Individuals With HIV/AIDS
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.
National Institute on Drug Abuse (NIDA) has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||THC and Marijuana--Effects in Individuals With HIV/AIDS|
- daily caloric intake [ Time Frame: daily measure of colories ] [ Designated as safety issue: No ]
|Study Start Date:||December 2001|
|Study Completion Date:||August 2005|
|Primary Completion Date:||August 2004 (Final data collection date for primary outcome measure)|
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.
|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|