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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00079560
Recruitment Status : Completed
First Posted : March 10, 2004
Last Update Posted : January 11, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: dronabinol Phase 1 Phase 2

Expanded Access : National Institute on Drug Abuse (NIDA) has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: THC and Marijuana--Effects in Individuals With HIV/AIDS
Study Start Date : December 2001
Actual Primary Completion Date : August 2004
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Marijuana
Drug Information available for: Dronabinol

Arms and Interventions
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Intervention Details:
  • Drug: dronabinol
    dronabinol to prevent development of marijuana withdrawal

Outcome Measures
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Primary Outcome Measures :
  1. daily caloric intake [ Time Frame: daily measure of colories ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • HIV infected
  • Smoke marijuana
  • Taking HIV medications

Exclusion criteria

  • Naive marijuana smokers
  • People with history of respiratory/pulmonary disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00079560


Locations
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United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Margaret Haney, PhD New York State Psychiatric Institute
More Information
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Responsible Party: Jag H. Khalsa, Ph.D., National Institute on Drug Abuse, NIH
ClinicalTrials.gov Identifier: NCT00079560    
Other Study ID Numbers: 1R01DA012698-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 10, 2004    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: October 2008
Keywords provided by National Institute on Drug Abuse (NIDA):
HIV
Marijuana
Marinol
 Oral THC
Appetite
Complementary Therapies
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists