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
  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 Intervention Phase
HIV Infections
Drug: dronabinol
Phase 1
Phase 2

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: THC and Marijuana--Effects in Individuals With HIV/AIDS

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • daily caloric intake [ Time Frame: daily measure of colories ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: December 2001
Study Completion Date: August 2005
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: dronabinol
    dronabinol to prevent development of marijuana withdrawal
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.

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079560

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
Investigators
Principal Investigator: Margaret Haney, PhD New York State Psychiatric Institute
  More Information

No publications provided

Responsible Party: Jag H. Khalsa, Ph.D., National Institute on Drug Abuse, NIH
ClinicalTrials.gov Identifier: NCT00079560     History of Changes
Other Study ID Numbers: 1 R01 DA12698-01A1
Study First Received: March 9, 2004
Last Updated: October 23, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):
HIV
Marijuana
Marinol
Oral THC
Appetite
Complementary Therapies

Additional relevant MeSH terms:
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on October 01, 2014