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Official title The Neural Underpinnings of Depression and Cannabis Use in Young People Living With HIV
ClinicalTrials.gov ID: NCT05453513
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 59
You may be able to join if
- 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...
- Cannabis users: To capture a wide range of cannabis use frequency, meeting Diagnostic and Statistical Manual 5 (DSM-5) criteria for Cannabis use...
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 59 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.