The Neural Underpinnings of Depression and Cannabis Use in Young People Living With HIV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-59
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
MRI Study
BehavioralfMRI Tasks
Treatment groups
280 Participants
are divided into 1 treatment groupGroup A: Neural Underpinnings of Depression GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Up to 1 year2
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 months3
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 months4
Neural Circuitry measured by MRI
Measured using Magnetic Resonance Imaging. Summary beta values representing the level of brain activity will be calculated.
Time frame
BaselineSecondary outcomes
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.
Time frame
Up to 12 months2
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 months3
tetrahydrocannabinol (THC) Metabolite, Serum
Suggests use of, or exposure to, a product containing THC. pmol/mL
Time frame
Up to 12 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Miami
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov