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Understanding Depression and Cannabis Use in Young People with HIV

This study is looking into how depression and cannabis use affect young people (ages 18-39) living with HIV. Researchers want to understand the brain's reward and pain systems in people who have both conditions. You would participate in an MRI study, which involves fMRI tasks (a type of brain scan). The goal is to see if having both depression and using cannabis creates additional challenges, leading to less enjoyment and more pain sensitivity, and how this might affect your health over one year. The study is currently recruiting 280 participants who have HIV and are fluent in English or Spanish.

Study design
This is an interventional study planning to enroll 280 participants. It is not specified if it's randomized or blinded.
What's involved
You would participate in an MRI study involving fMRI tasks. Your addiction severity, depression, and ability to experience pleasure would be measured for up to 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to one year to assess outcomes related to addiction severity, depression, and pleasure.

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NCT05453513

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

Recruiting
NAAges 18–59InterventionalBasic science
University of Miami
~280 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:MRI Study

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Addiction Severity Index (ASI)
Measured over Up to 1 year
+3 more outcomes measured

Conditions

Depression
Cannabis Use Disorder
HIV

Explore related trials

Cannabis Use DisorderDepressionHIV Infection

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Vilma Gabbay, MD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Vilma Gabbay, MD
[email protected]
305-243-2382
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 such as end-stage renal disease, heart failure, cirrhosis, or cancer
MRI contraindication such as claustrophobia, metallic ink tattoos, or pacemaker.
At baseline, all participants will be psychotropic-medication-free for ≥1 month prior to study enrollment (or ≥3 months for medications with longer half-lives). Benzodiazepines and sleeping aids taken on an as-needed basis will be allowed, however we will require a 4-day abstinence period before the scan.
Exclusionary are participants with a DSM-5 diagnoses of bipolar disorder, psychotic disorders, autism spectrum disorders, and all non-cannabis substance-related disorders will be exclusionary. disorder (PTSD) are not uncommon among depressed individuals and will be
Anxiety disorders, obsessive-compulsive disorder (OCD), and post-traumatic stress are allowed as long as depressive symptoms are primary.

What this trial measures

  • Addiction Severity Index (ASI)Up to 1 year

    The number of days using illicit opioids in the past 30 days per self-report as collected through the Addiction Severity Index.

  • Montgomery Asberg Depression Rating Scale (MADRS) ScaleUp to 12 months

    Measures the severity of depressive episodes in patients with mood disorders Scale 0-60 higher more severe

  • Temporal Experience of Pleasure Scale (TEPS)Up to 12 months

    Self-report measure allowing the assessment of anticipatory and consummatory pleasure 25 to 120 higher more pleasure

  • Neural Circuitry measured by MRIBaseline

    Measured using Magnetic Resonance Imaging. Summary beta values representing the level of brain activity will be calculated.