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

Tracking Information

First Received Date ^ICMJE

March 9, 2004

Last Updated Date

October 23, 2008

Start Date ^ICMJE

December 2001

Primary Completion Date

August 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00079560 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

THC and Marijuana--Effects in Individuals With HIV/AIDS

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.

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 Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: dronabinol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2005

Primary Completion Date

August 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria

HIV infected
Smoke marijuana
Taking HIV medications

Exclusion criteria

Naive marijuana smokers
People with history of respiratory/pulmonary disease

Gender

Both

Ages

21 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00079560

Responsible Party

Jag H. Khalsa, Ph.D., National Institute on Drug Abuse, NIH

Study ID Numbers ^ICMJE

1 R01 DA12698-01A1

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Margaret Haney, PhD

New York State Psychiatric Institute

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

October 2008

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