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

THC and Marijuana--Effects in Individuals With HIV/AIDS

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00079560
Enrollment
30
Registered
2004-03-10
Start date
2001-12-31
Completion date
2005-08-31
Last updated
2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV, Marijuana, Marinol, Oral THC, Appetite, Complementary Therapies

Brief 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.

Detailed 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.

Interventions

DRUGdronabinol

dronabinol to prevent development of marijuana withdrawal

Sponsors

National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* HIV infected * Smoke marijuana * Taking HIV medications

Exclusion criteria

* Naive marijuana smokers * People with history of respiratory/pulmonary disease

Design outcomes

Primary

MeasureTime frame
daily caloric intakedaily measure of colories

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026