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Comparing the Effects of Smoked and Oral Marijuana in Individuals with HIV/AIDS - Article


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Dronabinol

Marinol



Clinical Trial: Comparing the Effects of Smoked and Oral Marijuana in Individuals with HIV/AIDS

This study is currently recruiting patients.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)

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 Treatment or Intervention Phase
HIV Infections
 Drug: dronabinol
Phase I
Phase II

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Official Title: THC and Marijuana--Effects in Individuals with HIV/AIDS

Further Study Details: 

Expected Total Enrollment:  30

Study start: December 2001

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   -   50 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

  • HIV infected
  • Smoke marijuana
  • Taking HIV medications

Location and Contact Information


New York
      New York State Psychiatric Institute, New York,  New York,  10032,  United States; Recruiting
Margaret Haney, PhD  212-543-5175    MH235@columbia.edu 

Study chairs or principal investigators

Margaret Haney, PhD,  Principal Investigator,  New York State Psychiatric Institute   

More Information

Study ID Numbers:  1 R01 DA12698-01A1
Record last reviewed:  November 2004
Last Updated:  November 18, 2004
Record first received:  March 9, 2004
ClinicalTrials.gov Identifier:  NCT00079560
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 18, 2008



Page Updated: June 1, 2005
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