Back to resultsComparing the Effects of Smoked and Oral Marijuana in Individuals With HIV/AIDS
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
dronabinol
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, Marijuana, Marinol, Oral THC, Appetite, Complementary Therapies
Eligibility Criteria
Inclusion Criteria HIV infected Smoke marijuana Taking HIV medications Exclusion criteria Naive marijuana smokers People with history of respiratory/pulmonary disease
Sites / Locations
- New York State Psychiatric Institute
Outcomes
Primary Outcome Measures
daily caloric intake
Secondary Outcome Measures
Full Information
NCT ID
NCT00079560
First Posted
March 9, 2004
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00079560
Brief Title
Comparing the Effects of Smoked and Oral Marijuana in Individuals With HIV/AIDS
Official Title
THC and Marijuana--Effects in Individuals With HIV/AIDS
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Marijuana, Marinol, Oral THC, Appetite, Complementary Therapies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
dronabinol
Intervention Description
dronabinol to prevent development of marijuana withdrawal
Primary Outcome Measure Information:
Title
daily caloric intake
Time Frame
daily measure of colories
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
HIV infected
Smoke marijuana
Taking HIV medications
Exclusion criteria
Naive marijuana smokers
People with history of respiratory/pulmonary disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Haney, PhD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparing the Effects of Smoked and Oral Marijuana in Individuals With HIV/AIDS
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