Investigating the effects of cannabis use and depression in young people living with HIV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the relationship between cannabis use and depression in young individuals living with HIV. It focuses on understanding how these two conditions interact and affect reward and pain processing in the brain. By assessing participants aged 18-39 who are HIV positive and have varying levels of cannabis use and depression, the study seeks to identify patterns that may predict worse health outcomes over a one-year follow-up period.

Why it matters

Who can join: the full rules

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:

• Exclusion criteria will be the same as depressed cannabis non-users except for cannabis use.

Non-depressed cannabis users:

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

Non-depressed cannabis non-users:

• Exclusion criteria will be the same as for non-depressed cannabis users; in addition participants will not report cannabis use in the prior 90 days and have a urine toxicology test negative for cannabis.

Where it's running

• University of Miami
  Miami, Florida, United States Recruiting

Study contacts

• Principal investigator: Vilma Gabbay, MD — University of Miami
• Study coordinator: Vilma Gabbay, MD
• Email: vxg595@med.miami.edu
• Phone: 305-243-2382

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Change My Story: a narrative game plus task-shifted therapy for young people with HIV

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• Investigating the link between inflammation and depression in people with HIV

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• Smartphone-supported single-session psychotherapy for postpartum depression

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.