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

NCT05453513 | Recruiting DMC

• 2 other identifiers: 20230798R01DA054885
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Cannabis Use Disorder; HIV

Outcome Measures

Primary Outcomes (4)

• Addiction Severity Index (ASI)

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

  Up to 1 year

• Montgomery Asberg Depression Rating Scale (MADRS) Scale

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

  Up to 12 months

• Temporal Experience of Pleasure Scale (TEPS)

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

  Up to 12 months

• Neural Circuitry measured by MRI

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

  Baseline

Secondary Outcomes (14)

• Daily Sessions Frequency Age Quantity of Cannabis Use Inventory (DFAQ- CU)

  Up to 12 months

• Timeline Followback (TLFB)

  Up to 12 months

• tetrahydrocannabinol (THC) Metabolite, Serum

  Up to 12 months

• Fagerström Test for Nicotine Dependence full-term normal delivery (FTND)

  Up to 12 months

• Beck Depression Inventory-II (BDI-II)

  Up to 12 months

Study Arms (1)

Neural Underpinnings of Depression Group

EXPERIMENTAL

All participants will undergo neuroimaging and behavioral tests. during the course of the study (12 months).

Behavioral: MRI Study

Interventions

MRI Study BEHAVIORAL

fMRI Tasks

Neural Underpinnings of Depression Group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Depressed cannabis non-users:
• 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.
• Anxiety disorders, obsessive-compulsive disorder (OCD), and post-traumatic stress are allowed as long as depressive symptoms are primary.
• atypical of depression. • Suicidal ideations (SI) without a specific plan (defined as passive SI) are common in depression and will be allowed. However, if SI constitutes an imminent risk to self or others (defined as active SI), the participant will be withdrawn from the study and emergency procedures will be initiated immediately, including ER admission.
• Depressed cannabis users:
• Non-depressed cannabis users:

Sponsors & Collaborators

• University of Miami: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Vilma Gabbay, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vilma Gabbay, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking, all participants will undergo the same procedures
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 12, 2022
• Study Start: April 1, 2022
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)