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Cannabinoid

Cannabis Derivatives for HIV

Phase < 1
Recruiting
Led By Arpi Minassian, Ph.D.
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Possess the capacity to provide informed consent to a set of neurobehavioral, neuromedical and cognitive assessment procedures. Individuals unable to provide such consent will not be enrolled into the study.
Infrequent use of cannabis, defined as 1-4 times per month. Must have used cannabis at least five times in the past two years without an adverse reaction.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 5 days after drug initiation

Summary

This trial will determine how cannabis use affects cognitive functioning and the endocannabinoid system in people with HIV, to better understand its implications for everyday functioning and risk of transmission.

Who is the study for?
This trial is for adults over 18 with HIV who can consent to tests and have used cannabis infrequently (1-4 times per month) without adverse reactions. They must be willing to avoid cannabis for at least 2 days before the study starts, confirmed by an oral fluid test.
What is being tested?
The study examines how THC (10 mg), CBD (600 mg), or a placebo affect decision-making, cognition, motivation, and dopamine activity in people with HIV compared to those without. Participants will take their assigned treatment for five days.
What are the potential side effects?
Potential side effects may include changes in attention, altered decision-making abilities, mood variations, and possible interactions with HIV treatments. The specific side effects of THC and CBD on this population are being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can understand and agree to the study's procedures.
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I use cannabis 1-4 times a month and have used it safely in the past two years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 5 days after drug initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 5 days after drug initiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
change in Continuous Performance Task score from baseline to post-intervention
change in Human Temporal Bisection Task score from baseline to post-intervention
change in Iowa Gambling Task score from baseline to post-intervention
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HIV-positive subjectsExperimental Treatment3 Interventions
Adult human subjects seropositive for HIV-1
Group II: Healthy Comparison VolunteersActive Control3 Interventions
Adult human subjects without HIV
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,587 Previous Clinical Trials
3,328,410 Total Patients Enrolled
University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,574,909 Total Patients Enrolled
Arpi Minassian, Ph.D.Principal InvestigatorUC San Diego

Media Library

Cannabidiol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04883255 — Phase < 1
HIV Research Study Groups: Healthy Comparison Volunteers, HIV-positive subjects
HIV Clinical Trial 2023: Cannabidiol Highlights & Side Effects. Trial Name: NCT04883255 — Phase < 1
Cannabidiol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04883255 — Phase < 1
~60 spots leftby Jan 2026
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