HIV and AIDS Trial, Recruiting NCT05453513 Sponsor: University of Miami Condition: HIV and AIDS
Back to Hiv Aids

HIV and AIDS Trial, Recruiting

NCT05453513
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have a confirmed HIV-positive diagnosis, verified by a lab report, medical records, or an HIV test.
  • People between the ages of 18 and 39 years old.
  • People who speak English or Spanish fluently.
  • People who are able to give informed consent and complete study tasks, including having an estimated IQ above 75 (to ensure study materials can be understood).
  • For the cannabis user groups: People who have used cannabis on at least 20 out of the past 30 days and have a positive cannabis urine test (a formal diagnosis of Cannabis Use Disorder is not required).
  • For the depressed groups: People experiencing at least a low level of depression symptoms, measured by a score of 12 or higher on a standard depression rating scale called the MADRS (a formal diagnosis of major depression is not required).

Who may not be able to join:

  • People who acquired HIV at birth or during early childhood (perinatal HIV).
  • People who are currently pregnant or breastfeeding.
  • People who currently have a substance use disorder for any substance other than cannabis or nicotine.
  • People who currently use medical cannabis, have a medical cannabis certification, or plan to obtain one.
  • People who currently use cocaine, based on self-report or a urine test.
  • People who have a disease or injury affecting the brain or nervous system, or a neurodegenerative condition.
  • People with certain pain-related conditions such as multiple sclerosis or rheumatoid arthritis.
  • People with serious medical illnesses such as end-stage kidney disease, heart failure, liver cirrhosis, or cancer.
  • People who are unable to have an MRI scan, for example due to severe claustrophobia, metallic ink tattoos, or a pacemaker.
  • People who have been taking psychiatric medications within the past month (or 3 months for certain longer-acting medications) — though benzodiazepines or sleeping aids taken occasionally as needed may be allowed, with a 4-day break required before any scan (confirm with trial site).
  • People with a diagnosed bipolar disorder, psychotic disorder, autism spectrum disorder, or a substance-related disorder other than cannabis.
  • People with active suicidal thoughts that involve a specific plan or pose an immediate risk to themselves or others.
  • For the non-depressed cannabis non-user group: People who have used cannabis at any point in the past 90 days, or who test positive for cannabis on a urine test.
  • For the non-depressed groups: People with any major psychiatric condition other than cannabis use.

Note: Anxiety disorders, OCD, and PTSD are not automatically disqualifying for the depressed groups, provided that depressive symptoms are the primary concern (confirm with trial site).


Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Vilma Gabbay, MD, University of Miami

Phone: 305-243-2382

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 April 2022
Est. completion
30 July 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Addiction Severity Index (ASI); Montgomery Asberg Depression Rating Scale (MADRS) Scale; Temporal Experience of Pleasure Scale (TEPS); Neural Circuitry measured by MRI

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov