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

History of Changes

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:

MedlinePlus related topics: HIV/AIDS Marijuana

Drug Information available for: Dronabinol

U.S. FDA Resources

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:

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 (Adult)
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

National Institute on Drug Abuse (NIDA)

Investigators


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

More Information


Responsible Party:	Jag H. Khalsa, Ph.D., National Institute on Drug Abuse, NIH
ClinicalTrials.gov Identifier:	NCT00079560 History of Changes
Other Study ID Numbers:	1R01DA012698-01A1
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:


HIV Infections Marijuana Abuse Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases 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

ClinicalTrials.gov processed this record on September 30, 2016

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