RecruitingNot Applicable

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

United States280 participantsStarted 2022-04-01

Plain-language summary

To elucidate mechanisms of substance use disorders (SUD) and comorbid mental illnesses in people living with HIV (PLWH), the study team seeks to investigate reward and pain circuitry in cannabis use and depression comorbidity, two highly prevalent conditions in PLWH. The study team proposes a tightly integrative study to test the overall hypothesis that cannabis use and depression in young PLWH have an additive effect, inducing both reward deficits and pain hypersensitivity, and that this pattern will predict worse outcomes at 1 year follow-up.

Who can participate

Age range

18 Years – 59 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * HIV seropositivity confirmed with lab report, medical records, or HIV testing. * Between the ages of 18-39 years * Fluency in English or Spanish * Ability to provide informed consent and perform study procedures, including estimated full-scale intelligence quotient (IQ) \>75 to ensure that participants are able to understand the study. * Cannabis users: To capture a wide range of cannabis use frequency, meeting Diagnostic and Statistical Manual 5 (DSM-5) criteria for Cannabis use Disorder (CUD) will not be required. However, in order to ensure sufficient exposure, cannabis use will be significant (self-reported use on ≥20 of the prior 30 days and positive THC urine toxicology). * Depressed: In order to capture a wide range of depression illness severity, we will allow participants with subthreshold depression, defined as a raw severity score of ≥12 on the Montgomery Asberg Depression Rating Scale (MADRS). Exclusion Criteria: * Perinatally acquired HIV infection, as early neurodevelopmental alterations and HIV legacy effects may exist in this group * Pregnancy or lactation * Current Substance Use Disorder other than cannabis or nicotine * Certified for or self-reported medical cannabis use, or intent to become certified * Current cocaine use by self-report or urine toxicology * central nervous system (CNS) disease or injury, or neuro-degenerative disease * Unique pain syndromes (e.g. multiple sclerosis, rheumatoid arthritis); * Severe medical illness s…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Addiction Severity Index (ASI)

Timeframe: Up to 1 year

Montgomery Asberg Depression Rating Scale (MADRS) Scale

Timeframe: Up to 12 months

Temporal Experience of Pleasure Scale (TEPS)

Timeframe: Up to 12 months

Neural Circuitry measured by MRI

Timeframe: Baseline

Trial details

NCT IDNCT05453513

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-30

Contact for this trial

Vilma Gabbay, MD

305-243-2382 vxg595@med.miami.edu

View on ClinicalTrials.gov More Depression trials