Comparing the Effects of Smoked and Oral Marijuana in Individuals With HIV/AIDS - Full Text View

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 I Phase II

MedlinePlus related topics:

AIDS

Drug Information available for:

Tetrahydrocannabinol Cannabis GW-1000

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study

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

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
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

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:	National Institute on Drug Abuse, NIH ( Jag H. Khalsa, Ph.D. )
Study ID Numbers:	1 R01 DA12698-01A1
First Received:	March 9, 2004
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00079560
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

Study placed in the following topic categories:

Tetrahydrocannabinol

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Physiological Effects of Drugs

Psychotropic Drugs

Hallucinogens

Infection

Pharmacologic Actions

Sensory System Agents

Analgesics, Non-Narcotic

Therapeutic Uses

Lentivirus Infections

Peripheral Nervous System Agents

Analgesics

Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00079560