An interventional study of MRI Study in Depression, Cannabis Use Disorder and HIV, sponsored by University of Miami. Recruiting at 1 site in United States. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by University of Miami · Not applicable, Interventional, and Basic science
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.
8,059 studies on the registry are indexed under Depression; 1,643 are open to participants now.
This study's planned enrollment of 280 is above the median of 84 across 6,722 interventional studies indexed under Depression.
Browse Depression studies →University of Miami is the lead sponsor of 821 studies on the registry; 162 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Depressed cannabis non-users:
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 However, if SI constitutes an imminent risk to self or others (defined as active SI), the participant will be withdrawn from the study and emergency procedures will be initiated immediately, including ER admission.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:
Non-depressed cannabis users:
Non-depressed cannabis non-users:
All participants will undergo neuroimaging and behavioral tests. during the course of the study (12 months).
Behavioral: MRI Study
fMRI Tasks
Addiction Severity Index (ASI)
The number of days using illicit opioids in the past 30 days per self-report as collected through the Addiction Severity Index.
Time frame: Up to 1 year
Montgomery Asberg Depression Rating Scale (MADRS) Scale
Measures the severity of depressive episodes in patients with mood disorders Scale 0-60 higher more severe
Time frame: Up to 12 months
Temporal Experience of Pleasure Scale (TEPS)
Self-report measure allowing the assessment of anticipatory and consummatory pleasure 25 to 120 higher more pleasure
Time frame: Up to 12 months
Neural Circuitry measured by MRI
Measured using Magnetic Resonance Imaging. Summary beta values representing the level of brain activity will be calculated.
Time frame: Baseline
Daily Sessions Frequency Age Quantity of Cannabis Use Inventory (DFAQ- CU)
Measures cannabis consumption Score range 0 to 185. The higher the score, the greater the usage of cannabis.
Time frame: Up to 12 months
Timeline Followback (TLFB)
Tool to obtain a variety of estimates of marijuana, cigarette, and other drug use. scores range from days of use (0-30)
Time frame: Up to 12 months
tetrahydrocannabinol (THC) Metabolite, Serum
Suggests use of, or exposure to, a product containing THC. pmol/mL
Time frame: Up to 12 months
Fagerström Test for Nicotine Dependence full-term normal delivery (FTND)
The FTND is a validated, 6-item self-report instrument that evaluates the intensity of physical addiction to nicotine. Three items are rated yes/no (0/1), and the other three items are rated on a scale from 0-3. Items are summed to yield a total score of 0-10, with higher scores reflecting greater nicotine dependence.
Time frame: Up to 12 months
Beck Depression Inventory-II (BDI-II)
Designed to assess the presence and severity of depressive symptoms Score 0-63 higher the score greater the depression
Time frame: Up to 12 months
Snaith-Hamilton Pleasure Scale (SHAPS)
Measures anhedonia, the inability to experience pleasure Score 0-42 greater the score greater the pleasure.
Time frame: Up to 12 months
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
Alcohol consumption will be measured using total score on the 3-item Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) which includes typical quantity and frequency, and frequency of binge drinking (# of drinks modified by age based on the NIAAA Youth Guide). Higher score indicates worse outcomes.
Time frame: Up to 12 months
Cannabis Use Problem Identification Test (CUPIT)
6-item self-reported questionnaire assessing cannabis use and dependence; Range 3-82, higher values indicating a more severe cannabis use disorder.
Time frame: Up to 12 months
Pittsburgh sleep quality index
Assesses sleep quality and disturbances over a month period Scores 0-24 higher the score greater sleep dysfunction
Time frame: up to 12 months
Brief Pain Inventory (BPI)
Assesses the severity of pain and its impact on functioning. Pain questionnaire (0-10; higher score=worse)
Time frame: up to 12 months
Pain Anxiety Symptom Scale (PASS-20)
Measures fear and anxiety responses specific to pain Range 0-100 higher the more anxiety symptoms
Time frame: up to 12 months
HIV RNA test
HIV RNA test detects HIV and not antibodies 20 to 10,000,000 copies/mL higher the amount the more infectious
Time frame: Baseline
cluster of differentiation 4 (CD4+) / cluster of differentiation 8 (CD8+)
Monitors the immune system Flow cytometry will be used to detect serum CD4, CD8
Time frame: Up to 12 months
HIV Visual Analogue Scale (HIV-VAS)
The VAS asks individuals to mark a line at the point along a continuum showing how much of each drug they have taken in the last 4 weeks 0-30 higher score worse pain
Time frame: 12 month
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Miami