The Neural Underpinnings of Depression and Cannabis Use in Young People Living With HIV
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 59 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at how cannabis use and depression affect the brain’s response to reward and pain in people ages 18–39 living with HIV. It will test whether having both is linked to less response to reward, more pain sensitivity, and worse outcomes after 1 year.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be ages 18–39 and have HIV confirmed by a test or medical record.
- Speak English or Spanish fluently.
- Be able to understand and agree to the study and complete its steps. Your estimated IQ score must be above 75.
- For cannabis user groups: report using cannabis on at least 20 of the past 30 days and have a positive urine test for THC, a chemical in cannabis. A cannabis use disorder diagnosis is not required.
- For depression groups: score at least 12 on the MADRS depression rating scale. People with symptoms below the level of a full depression diagnosis may join.
- For depression groups: anxiety, obsessive-compulsive disorder (OCD), or post-traumatic stress disorder (PTSD) is allowed if depression is the main problem.
- For the group without depression or cannabis use: no cannabis use in the past 90 days and a negative urine test for cannabis.
Who can't join
- HIV acquired around birth, pregnancy, or breastfeeding.
- A current substance use disorder other than cannabis or nicotine; current cocaine use; or medical cannabis use, certification, or plans to get certified.
- A brain or spinal cord disease or injury, a disease that causes nerve cells to break down, or certain pain conditions such as multiple sclerosis or rheumatoid arthritis.
- A severe illness, such as kidney failure, heart failure, severe liver scarring, or cancer.
- A reason you cannot have an MRI scan, such as fear of tight spaces, metallic ink tattoos, or a pacemaker.
- For depression groups: use of medicines for mental health within the past month, or 3 months for longer-lasting medicines. As-needed benzodiazepines or sleep aids are allowed, but must be stopped for 4 days before the scan.
- For depression groups: bipolar disorder, disorders that affect contact with reality, autism, or non-cannabis substance-related disorders. Suicidal thoughts without a plan are allowed, but an immediate risk of harm to yourself or others leads to withdrawal and emergency care.
- For groups without depression: any major mental health condition other than cannabis use or cannabis use disorder.
Simplified for readability. The official criteria below are what the study team uses.
Official 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: • 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.
Study sites (1)
FL
- University of Miami · Miami, FL 33136Jasmine Agreda, BS · Study contact · 305-243-5510 · jja145@med.miami.eduJoanna Starrels, MD · Sub-investigatorAnjali Sharma, MD · Sub-investigatorVilma Gabbay, MD · Principal investigatorMore trials in Miami