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

NCT ID: NCT05453513

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2027-07-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Neural Underpinnings of Depression Group

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

Group Type: EXPERIMENTAL

MRI Study

Intervention Type: BEHAVIORAL

fMRI Tasks

Interventions

MRI Study

fMRI Tasks

Intervention Type: BEHAVIORAL

Eligibility Criteria

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 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.
• 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.

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:

• Will have no major psychiatric conditions other than cannabis use/disorder.

Non-depressed cannabis non-users:

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Vilma Gabbay

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vilma Gabbay, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Vilma Gabbay, MD

Role: CONTACT

vxg595@med.miami.edu

305-243-2382

Facility Contacts

Jasmine Agreda, BS

Role: primary

jja145@med.miami.edu

305-243-5510

Other Identifiers

R01DA054885

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20230798

Identifier Type: -

Identifier Source: org_study_id