Cannabis Use Disorder, Depression, HIV
Conditions
Brief 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. 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.
Interventions
BEHAVIORALMRI Study
fMRI Tasks
Sponsors
University of Miami
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
No masking, all participants will undergo the same procedures
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
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: •
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Addiction Severity Index (ASI) | Up to 1 year | The number of days using illicit opioids in the past 30 days per self-report as collected through the Addiction Severity Index. |
| Montgomery Asberg Depression Rating Scale (MADRS) Scale | Up to 12 months | Measures the severity of depressive episodes in patients with mood disorders Scale 0-60 higher more severe |
| Temporal Experience of Pleasure Scale (TEPS) | Up to 12 months | Self-report measure allowing the assessment of anticipatory and consummatory pleasure 25 to 120 higher more pleasure |
| Neural Circuitry measured by MRI | Baseline | Measured using Magnetic Resonance Imaging. Summary beta values representing the level of brain activity will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Sessions Frequency Age Quantity of Cannabis Use Inventory (DFAQ- CU) | Up to 12 months | Measures cannabis consumption Score range 0 to 185. The higher the score, the greater the usage of cannabis. |
| Timeline Followback (TLFB) | Up to 12 months | Tool to obtain a variety of estimates of marijuana, cigarette, and other drug use. scores range from days of use (0-30) |
| tetrahydrocannabinol (THC) Metabolite, Serum | Up to 12 months | Suggests use of, or exposure to, a product containing THC. pmol/mL |
| Fagerström Test for Nicotine Dependence full-term normal delivery (FTND) | Up to 12 months | 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. |
| Beck Depression Inventory-II (BDI-II) | Up to 12 months | Designed to assess the presence and severity of depressive symptoms Score 0-63 higher the score greater the depression |
| Snaith-Hamilton Pleasure Scale (SHAPS) | Up to 12 months | Measures anhedonia, the inability to experience pleasure Score 0-42 greater the score greater the pleasure. |
| Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) | Up to 12 months | 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. |
| Cannabis Use Problem Identification Test (CUPIT) | Up to 12 months | 6-item self-reported questionnaire assessing cannabis use and dependence; Range 3-82, higher values indicating a more severe cannabis use disorder. |
| Pittsburgh sleep quality index | up to 12 months | Assesses sleep quality and disturbances over a month period Scores 0-24 higher the score greater sleep dysfunction |
| Brief Pain Inventory (BPI) | up to 12 months | Assesses the severity of pain and its impact on functioning. Pain questionnaire (0-10; higher score=worse) |
| Pain Anxiety Symptom Scale (PASS-20) | up to 12 months | Measures fear and anxiety responses specific to pain Range 0-100 higher the more anxiety symptoms |
| HIV RNA test | Baseline | HIV RNA test detects HIV and not antibodies 20 to 10,000,000 copies/mL higher the amount the more infectious |
| cluster of differentiation 4 (CD4+) / cluster of differentiation 8 (CD8+) | Up to 12 months | Monitors the immune system Flow cytometry will be used to detect serum CD4, CD8 |
| HIV Visual Analogue Scale (HIV-VAS) | 12 month | 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 |
Countries
United States
Contacts
CONTACTVilma Gabbay, MD
PRINCIPAL_INVESTIGATORVilma Gabbay, MD
University of Miami
Outcome results
None listed