Cannabis Use, Cognition, and the Endocannabinoid System in HIV

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-03

Study Completion Date

2026-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Understanding how co-morbidities in persons with HIV (PWH) such as substance use affect risk-taking, decision-making, and other cognitive behaviors is important given implications for everyday functioning and transmission risk. The high prevalence of cannabis use in PWH, medicinally and recreationally, may indicate disease severity, impart therapeutic benefits, or adverse consequences. In fact, cannabis is recommended to those with HIV to alleviate nausea, improve appetite, relieve pain, and lift mood. To-date, the consequences of cannabis use in PWH remain unclear as do potential interactions with HIV treatments. In healthy participants, heavy cannabis use is associated with cognitive deficits e.g., risky decision-making, response disinhibition and inattention, but pro-cognitive effects in PWH may exist at mild use levels due to its anti-inflammatory and anti-excitotoxic properties. Furthermore, little has been done to determine the effects of cannabis use on the endocannabinoid (EC) system in general or in PWH. This study will determine the effects of the two primary cannabis constituents (Δ9-tetrahydrocannabinol \[THC\], cannabidiol \[CBD\]) vs. placebo on risky decision-making, response inhibition, reward learning, temporal perception, and motivation, plus EC and homovanillic acid (HVA; a surrogate for dopamine activity) levels in HIV+ and HIV- subjects. Participants with infrequent cannabis use will undergo baseline cognitive testing and biomarker assays with antiretrovirals (ART) use quantified. They will be randomized to a 5-day course of either THC, CBD, or placebo and return for follow-up testing and re-assaying of ECs and HVA levels.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Integrated Treatment of Marijuana Abuse for HIV+ Youth

NCT00683488

HIV Infections

COMPLETED NA

The Neural Underpinnings of Depression and Cannabis Use in Young People Living With HIV

NCT05453513

Depression Cannabis Use Disorder HIV

RECRUITING NA

Cognitive Behavioral Stress Management for HIV+ Drug Abusers

NCT00722644

HIV/AIDS Drug Abuse Alcohol Abuse

COMPLETED PHASE1

A Study of Cannabidiol in Young Adult Cannabis Users

NCT06569394

Cannabis Use Disorder

RECRUITING PHASE2

Cognitive Behavioral Treatment to Reduce Alcohol Use Among HIV-Infected Kenyans

NCT00792519

Binge Drinking Alcohol Abuse Alcohol Dependence +1 more

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV-1-infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HIV-positive subjects

Adult human subjects seropositive for HIV-1

Group Type EXPERIMENTAL

10 mg Δ9-tetrahydrocannabinol (THC)

Intervention Type DRUG

5-day course of orally-administered THC (dronabinol), 10 mg

600 mg cannabidiol (CBD)

Intervention Type DRUG

5-day course of orally-administered CBD, 600 mg

Placebo

Intervention Type DRUG

5-day course of orally-administered placebo

Healthy Comparison Volunteers

Adult human subjects without HIV

Group Type ACTIVE_COMPARATOR

10 mg Δ9-tetrahydrocannabinol (THC)

Intervention Type DRUG

5-day course of orally-administered THC (dronabinol), 10 mg

600 mg cannabidiol (CBD)

Intervention Type DRUG

5-day course of orally-administered CBD, 600 mg

Placebo

Intervention Type DRUG

5-day course of orally-administered placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

10 mg Δ9-tetrahydrocannabinol (THC)

5-day course of orally-administered THC (dronabinol), 10 mg

Intervention Type DRUG

600 mg cannabidiol (CBD)

5-day course of orally-administered CBD, 600 mg

Intervention Type DRUG

Placebo

5-day course of orally-administered placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Aged 18-65
2. 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.
3. Willing to confirm self-reported HIV using a rapid test: HIV status will be determined using the MedMira Rapid Test (Halifax, Nova Scotia, Canada). If the result differs from the participant's self-report a confirmatory Western Blot will be performed.
4. Willing to abstain from cannabis for at least 1 week prior to the baseline visit and during the study. Although there is no definitive method for determining abstinence over this period, abstinence will be confirmed as best as possible by using an oral fluid testing device (Draeger 5000) employed by law enforcement officers to detect recent cannabis use. An oral fluid value of \> 5ng suggests recent use, although in some cases it has been reported that individuals may show \> 5ng up to 20 hours after use. Thus, should the oral fluid sample indicate \> 5ng THC, the assessment may be canceled and rescheduled.

Exclusion Criteria

* Inability to provide informed consent
* Significant chronic renal disease (unrelated to HIV), significant chronic pulmonary disease (unrelated to HIV), or Hepatitis C Virus infection
* Head injury with loss of consciousness for greater than 30 minutes or resulting in neurologic complications
* Seizure disorder
* Demyelinating diseases or other non-HIV neurological disorders
* Pregnancy
* Acute or recent or previous clinically disabling stroke or previous cerebrovascular events
* Lifetime history of schizophrenia or other psychotic disorders, or bipolar disorder.
* Beck Depression Inventory-II (BDI-II) score is greater than or equal to 29 (severe depression) or suicidal ideas are endorsed on the BDI-II or a Center for Epidemiological Studies-Depression Scale (CES-D) subscale measuring suicidal ideation
* Substance use disorder (mild, moderate or severe) within the last 12 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes