Actively Recruiting

Phase Not Applicable
Age: 18Years - 59Years
All Genders
NCT05453513

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

Led by University of Miami · Updated on 2025-07-28

280

Participants Needed

1

Research Sites

278 weeks

Total Duration

On this page

Sponsors

U

University of Miami

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 59Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 IQ greater than 75
  • Significant cannabis use defined as self-reported use on 20 or more of the prior 30 days and positive THC urine toxicology
  • Depression including subthreshold severity defined as a raw score of 12 or higher on the Montgomery Asberg Depression Rating Scale (MADRS)
Not Eligible

You will not qualify if you...

  • Perinatally acquired HIV infection
  • Pregnancy or lactation
  • Current substance use disorder other than cannabis or nicotine
  • Certified or self-reported medical cannabis use, or intent to become certified
  • Current cocaine use by self-report or urine toxicology
  • Central nervous system disease or injury, or neurodegenerative disease
  • Unique pain syndromes such as multiple sclerosis or rheumatoid arthritis
  • Severe medical illnesses including end-stage renal disease, heart failure, cirrhosis, or cancer
  • MRI contraindications such as claustrophobia, metallic ink tattoos, or pacemaker
  • For depressed cannabis non-users: psychotropic medication use within 1 month prior to enrollment (3 months for long half-life medications), except benzodiazepines or sleeping aids with 4-day abstinence before scan
  • Diagnoses of bipolar disorder, psychotic disorders, autism spectrum disorders, and non-cannabis substance-related disorders (PTSD allowed if depression is primary)
  • Imminent suicidal ideation requiring emergency intervention
  • For non-depressed cannabis users: no major psychiatric conditions other than cannabis use disorder
  • For non-depressed cannabis non-users: no cannabis use in prior 90 days and negative urine toxicology for cannabis

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

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Research Team

V

Vilma Gabbay, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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