No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 59
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
280 (estimated)
Sponsor
University of Miami · Other
Who this trial is looking for
This trial is looking for young people living with HIV who have depression or use cannabis. Participants will be asked to complete some study procedures to better understand how these issues affect each other.
Are You a Good Fit for This Trial?
Rules you outBipolar disorderPsychotic disordersAutism spectrum disordersPost-traumatic stress disorder
You may be able to join if
I am between 18 and 39 years old.
I have been diagnosed with HIV.
I can speak English or Spanish.
I can provide informed consent and understand study procedures.
I use cannabis frequently.
I have depression symptoms.
You may not be able to join if
I was born with HIV.
I am pregnant or breastfeeding.
I have a current substance use disorder other than cannabis or nicotine.
I use medical cannabis or plan to use it.
I currently use cocaine.
I have a central nervous system disease or injury.
I have severe medical illnesses like cancer or heart failure.
I cannot have an MRI due to claustrophobia or metal implants.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 ha…
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.
Trial Locations
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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 t…
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.
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