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DepressionNCT05453513

The Neural Underpinnings of Depression and Cannabis Use in Young People Living With HIV

A study testing MRI Study in people with Depression and Cannabis Use Disorder, run by University of Miami at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 59 years
Conditions the study is for
Depression, Cannabis Use Disorder, HIV
What is being tested?
MRI Study
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
1 siteUnited States
Study dates
1 Apr 2022to 30 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 20Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vilma Gabbay, MD contact

305-243-2382

vxg595@med.miami.edu

United States1 site, 1 recruiting

  • University of Miami

    Miami, Florida, 33136

    Jasmine Agreda, BS, 305-243-5510, jja145@med.miami.edu

    Joanna Starrels, MD

    Recruiting

Other trials in United States

About this study

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.

Being tested
MRI Study
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRI StudyBehavioural

    fMRI Tasks

Study groups in NCT05453513
Study groupRoleWhat they receive
Neural Underpinnings of Depression GroupExperimentalAll participants will undergo neuroimaging and behavioral tests. during the course of the study (12 months).
Receives: Behavioral: MRI Study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 1 year

  2. Montgomery Asberg Depression Rating Scale (MADRS) Scale

    Measures the severity of depressive episodes in patients with mood disorders Scale 0-60 higher more severe

    Measured: Up to 12 months

  3. Temporal Experience of Pleasure Scale (TEPS)

    Self-report measure allowing the assessment of anticipatory and consummatory pleasure 25 to 120 higher more pleasure

    Measured: Up to 12 months

  4. Neural Circuitry measured by MRI

    Measured using Magnetic Resonance Imaging. Summary beta values representing the level of brain activity will be calculated.

    Measured: Baseline

Secondary outcomes (14)

  1. 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.

    Measured: Up to 12 months

  2. 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)

    Measured: Up to 12 months

  3. tetrahydrocannabinol (THC) Metabolite, Serum

    Suggests use of, or exposure to, a product containing THC. pmol/mL

    Measured: Up to 12 months

  4. 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.

    Measured: Up to 12 months

  5. 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

    Measured: Up to 12 months

  6. Snaith-Hamilton Pleasure Scale (SHAPS)

    Measures anhedonia, the inability to experience pleasure Score 0-42 greater the score greater the pleasure.

    Measured: Up to 12 months

  7. 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.

    Measured: Up to 12 months

  8. 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.

    Measured: Up to 12 months

  9. Pittsburgh sleep quality index

    Assesses sleep quality and disturbances over a month period Scores 0-24 higher the score greater sleep dysfunction

    Measured: up to 12 months

  10. Brief Pain Inventory (BPI)

    Assesses the severity of pain and its impact on functioning. Pain questionnaire (0-10; higher score=worse)

    Measured: up to 12 months

  11. Pain Anxiety Symptom Scale (PASS-20)

    Measures fear and anxiety responses specific to pain Range 0-100 higher the more anxiety symptoms

    Measured: up to 12 months

  12. HIV RNA test

    HIV RNA test detects HIV and not antibodies 20 to 10,000,000 copies/mL higher the amount the more infectious

    Measured: Baseline

  13. cluster of differentiation 4 (CD4+) / cluster of differentiation 8 (CD8+)

    Monitors the immune system Flow cytometry will be used to detect serum CD4, CD8

    Measured: Up to 12 months

  14. 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

    Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2022
  2. Study start1 Apr 2022
  3. Primary completion30 Jul 2027 (estimated)
  4. Study completion30 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05453513
Sponsor's protocol ID
20230798
Other IDs
R01DA054885
Status last verified
Jun 2026
First submitted
1 Jul 2022
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MRI Study in people with Depression and Cannabis Use Disorder, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vilma Gabbay, MD (305-243-2382, vxg595@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Addiction Severity Index (ASI) (time frame: Up to 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05453513.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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