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NCT00079560 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
THC and Marijuana--Effects in Individuals With HIV/AIDS

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00079560
Other study ID # 1R01DA012698-01A1
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received March 9, 2004
Last updated January 10, 2017
Start date December 2001
Est. completion date August 2005

Study information
Verified date October 2008
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date August 2005
Est. primary completion date August 2004
Accepts healthy volunteers No
Gender All
Age group 21 Years to 50 Years
Eligibility Inclusion Criteria

- HIV infected

- Smoke marijuana

- Taking HIV medications

Exclusion criteria

- Naive marijuana smokers

- People with history of respiratory/pulmonary disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• dronabinol
dronabinol to prevent development of marijuana withdrawal

Locations
Country Name City State
United States New York State Psychiatric Institute New York New York

Sponsors (1)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary daily caloric intake daily measure of colories No
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