Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Mental Disorders
+1

+ Marijuana Abuse
+ Substance-Related Disorders
From 21 to 50 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: December 2001
See protocol details

Summary

Principal SponsorNational Institute on Drug Abuse (NIDA)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2001Actual date on which the first participant was enrolled.

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.

Official TitleTHC and Marijuana--Effects in Individuals With HIV/AIDS 
NCT000795601R01DA012698-01A1
Principal SponsorNational Institute on Drug Abuse (NIDA)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
30 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different treatments one after the other, switching from one to another during the study. This helps researchers understand how individuals respond to multiple treatments.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 21 to 50 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Mental Disorders
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Criteria

Inclusion Criteria * HIV infected * Smoke marijuana * Taking HIV medications Exclusion criteria * Naive marijuana smokers * People with history of respiratory/pulmonary disease

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
New York State Psychiatric InstituteNew York, United StatesSee the location
CompletedOne Study Center
;