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

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status and phase

Completed
Phase 2
Phase 1

Conditions

HIV Infections

Treatments

Drug: dronabinol

Study type

Interventional

Funder types

NIH

Identifiers

NCT00079560
1R01DA012698-01A1

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

21 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

  • HIV infected
  • Smoke marijuana
  • Taking HIV medications

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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