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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00079560
First received: March 9, 2004
Last updated: October 23, 2008
Last verified: October 2008

March 9, 2004
October 23, 2008
December 2001
August 2004   (final data collection date for primary outcome measure)
daily caloric intake [ Time Frame: daily measure of colories ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00079560 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
HIV Infections
Drug: dronabinol
dronabinol to prevent development of marijuana withdrawal
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2005
August 2004   (final data collection date for primary outcome measure)

Inclusion Criteria

  • HIV infected
  • Smoke marijuana
  • Taking HIV medications

Exclusion criteria

  • Naive marijuana smokers
  • People with history of respiratory/pulmonary disease
Both
21 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00079560
1 R01 DA12698-01A1
No
Jag H. Khalsa, Ph.D., National Institute on Drug Abuse, NIH
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: Margaret Haney, PhD New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP