Comparing the Effects of Smoked and Oral Marijuana in Individuals With HIV/AIDS
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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 1 Phase 2 |
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 Type: | Interventional |
| 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 ]
| Enrollment: | 30 |
| Study Start Date: | December 2001 |
| Study Completion Date: | August 2005 |
| Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
-
Drug: dronabinol
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
- HIV infected
- Smoke marijuana
- Taking HIV medications
Exclusion criteria
- Naive marijuana smokers
- People with history of respiratory/pulmonary disease
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Jag H. Khalsa, Ph.D., National Institute on Drug Abuse, NIH |
| ClinicalTrials.gov Identifier: | NCT00079560 History of Changes |
| Other Study ID Numbers: | 1 R01 DA12698-01A1 |
| Study First Received: | March 9, 2004 |
| Last Updated: | October 23, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Institute on Drug Abuse (NIDA):
|
HIV Marijuana Marinol |
Oral THC Appetite Complementary Therapies |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Marijuana Abuse Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Substance-Related Disorders |
Mental Disorders Tetrahydrocannabinol Hallucinogens Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013