RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-04-01

Study Completion:2027-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05453513

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 39 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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).	* 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.

Inclusion Criteria

Exclusion 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).

* 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.

Contacts and Locations

Study Contact

Vilma Gabbay, MD

CONTACT

305-243-2382

vxg595@med.miami.edu

Principal Investigator

Vilma Gabbay, MD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: University of Miami

Vilma Gabbay, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-01

Study Completion Date2027-07-30

Study Record Updates

Study Start Date2022-04-01

Study Completion Date2027-07-30

Terms related to this study

Additional Relevant MeSH Terms

Hiv
Depression
Cannabis Use Disorder