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

Primary Purpose

Hiv, Depression, Cannabis Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI study - everyone scanned.
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hiv

Eligibility Criteria

18 Years - 34 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV seropositivity confirmed with lab report, medical records, or HIV testing.
  • Between the ages of 18-34 years
  • Fluency in English or Spanish
  • Ability to provide informed consent and perform study procedures, including estimated full-scale IQ >75 to ensure that participants are able to understand the study.
  • Cannabis users: To capture a wide range of cannabis use frequency, meeting DSM-5 criteria for 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
  • 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:

• 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.

Sites / Locations

  • Vilma Gabbay, MD, MSRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PLWH

Arm Description

All participants will undergo neuroimaging and behavioral tests.

Outcomes

Primary Outcome Measures

Addiction Severity Index (ASI)
Tool widely used in the evaluation of substance use treatment. It looks at history, frequency, and consequences of alcohol and drug use.
Montgomery Asberg Depression Rating Scale (MADRS) Scale 0-60 higher more severe
Measures the severity of depressive episodes in patients with mood disorders
Temporal Experience of Pleasure Scale (TEPS) 25 to 120 higher more pleasure
Self-report measure allowing the assessment of anticipatory and consummatory pleasure
neural circuitry underling reward and pain
fMRI based tasks to measure brain activation during reward and pain processes

Secondary Outcome Measures

Daily Sessions Frequency Age Quantity of Cannabis Use Inventory (DFAQ- CU) Score range 0 to 185. The higher the score, the greater the usage of cannabis.
Measures cannabis consumption
Daily sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ- CU) Score range 0 to 185. The higher the score, the greater the usage of cannabis.
Measures cannabis consumption
Daily sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ- CU) Score range 0 to 185. The higher the score, the greater the usage of cannabis.
Measures cannabis consumption
Time Flowback (TLFB) Higher the score the greater the use.
Tool to obtain a variety of quantitative estimates of marijuana, cigarette, and other drug use.
Time Flowback (TLFB) Higher the score the greater the use.
Tool to obtain a variety of quantitative estimates of marijuana, cigarette, and other drug use.
Time Flowback (TLFB) Higher the score the greater the use.
Tool to obtain a variety of quantitative estimates of marijuana, cigarette, and other drug use.
THC Metabolite, Serum
Suggests use of, or exposure to, a product containing THC.
THC Metabolite, Serum
Suggests use of, or exposure to, a product containing THC.
THC Metabolite, Serum
Suggests use of, or exposure to, a product containing THC.
Fagerstrom test of nicotine dependence
Examines physical intensity of addiction to nicotine
Fagerstrom test of nicotine dependence
Examines physical intensity of addiction to nicotine
Fagerstrom test of nicotine dependence
Examines physical intensity of addiction to nicotine
Beck Depression Inventory-II (BDI-II) Score 0-63 higher the score greater the depression
Designed to assess the presence and severity of depressive symptoms
Beck Depression Inventory-II (BDI-II) Score 0-63 higher the score greater the depression
Designed to assess the presence and severity of depressive symptoms
Beck Depression Inventory-II (BDI-II) Score 0-63 higher the score greater the depression
Designed to assess the presence and severity of depressive symptoms
Snaith-Hamilton Pleasure Scale (SHAPS) Score 0-42 greater the score greater the pleasure.
Measures anhedonia, the inability to experience pleasure.
Snaith-Hamilton Pleasure Scale (SHAPS) Score 0-42 greater the score greater the pleasure.
Measures anhedonia, the inability to experience pleasure.
Snaith-Hamilton Pleasure Scale (SHAPS) Score 0-42 greater the score greater the pleasure.
Measures anhedonia, the inability to experience pleasure.
AUDIT-C The higher the score the greater the alcohol use disorder.
Identify persons who are hazardous drinkers or have active alcohol use disorders
AUDIT-C The higher the score the greater the alcohol use disorder.
Identify persons who are hazardous drinkers or have active alcohol use disorders
AUDIT-C The higher the score the greater the alcohol use disorder.
Identify persons who are hazardous drinkers or have active alcohol use disorders
CUPIT The higher the score the more problematic the use.
Measures risky and problematic cannabis use.
CUPIT The higher the score the more problematic the use.
Measures risky and problematic cannabis use.
CUPIT The higher the score the more problematic the use.
Measures risky and problematic cannabis use.
Pittsburgh sleep quality index Scores 0-24 higher the score greater sleep dysfunction
Assesses sleep quality and disturbances over a month period
Pittsburgh sleep quality index Scores 0-24 higher the score greater sleep dysfunction
Assesses sleep quality and disturbances over a month period
Pittsburgh sleep quality index Scores 0-24 higher the score greater sleep dysfunction
Assesses sleep quality and disturbances over a month period
Addiction Severity Index (ASI)
Tool widely used in the evaluation of substance use treatment. It looks at history, frequency, and consequences of alcohol and drug use.
Addiction Severity Index (ASI)
Tool widely used in the evaluation of substance use treatment. It looks at history, frequency, and consequences of alcohol and drug use.
Montgomery Asberg Depression Rating Scale (MADRS) Scale 0-60 higher more severe
Measures the severity of depressive episodes in patients with mood disorders
Temporal Experience of Pleasure Scale (TEPS) 25 to 120 higher more pleasure
Self-report measure allowing the assessment of anticipatory and consummatory pleasure
Brief Pain Inventory (BPI) The higher the score the greater the pain severity and impairment on functioning.
Assesses the severity of pain and its impact on functioning.
Brief Pain Inventory (BPI) The higher the score the greater the pain severity and impairment on functioning.
Assesses the severity of pain and its impact on functioning.
Temporal Experience of Pleasure Scale (TEPS) 25 to 120 higher more pleasure
Self-report measure allowing the assessment of anticipatory and consummatory pleasure
Pain Anxiety Symptom Scale (PASS-20) Range 0-100 higher the more anxiety symptoms
Measures fear and anxiety responses specific to pain.
HIV RNA test 20 to 10,000,000 copies/mL higher the amount the more infectious
HIV RNA test detects HIV and not antibodies
CD4+ CD8+
Monitors the immune system
CD4+ CD8+
Monitors the immune system
CD4+ CD8+
Monitors the immune system
Montgomery Asberg Depression Rating Scale (MADRS) Range 0-60 higher more severe
Measures the severity of depressive episodes in patients with mood disorders
Brief Pain Inventory (BPI) The higher the score the greater the pain severity and impairment on functioning.
Assesses the severity of pain and its impact on functioning.
Pain Anxiety Symptom Scale (PASS-20) Range 0-100 higher the more anxiety symptoms
Measures fear and anxiety responses specific to pain.
Pain Anxiety Symptom Scale (PASS-20) Range 0-100 higher the more anxiety symptoms
Measures fear and anxiety responses specific to pain.
HIV Visual Analogue Scale (HIV-VAS) 0-30 higher score worse pain
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.

Full Information

First Posted
July 1, 2022
Last Updated
July 18, 2023
Sponsor
Albert Einstein College of Medicine
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05453513
Brief Title
The Neural Underpinnings of Depression and Cannabis Use in Young People Living With HIV
Official Title
The Neural Underpinnings of Depression and Cannabis Use in Young People Living With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
July 1, 2026 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To elucidate mechanisms of substance use disorders (SUD) and comorbid mental illnesses in people living with HIV (PLWH), the investigators propose to investigate reward and pain circuitry in cannabis use and depression comorbidity, two highly prevalent conditions in PLWH. The study will take place in our health system in The Bronx-a persistent epicenter of the HIV epidemic due to profound poverty and health disparities. The focus is on young adults (ages 18-34) to minimize HIV chronicity effects and due to the high rates of SUD and reduced adherence to HIV treatments in this age group; among >31,000 diagnosed young PLWH in The Bronx in 2019, less than 70% had suppressed (<200 copies/mL) viral load (VL).
Detailed Description
We propose to investigate reward and pain circuitry in cannabis use and depression comorbidity, two highly prevalent conditions in PLWH. We will focus on young adults (ages 18-34) to minimize HIV neuronal chronicity effects and in light of the high rates of substance use and reduced adherence to HIV treatment in this age group. Our proposed model is: 1) Both reward dysfunction (deficits in reward learning, expectancy, attainment, positive prediction errors) and pain hypersensitivity (pain sensitivity, aversion, negative prediction errors) contribute to cannabis use and depression comorbidity in young PLWH. 2) The habenula (Hb), a small limbic hub, plays a pivotal regulatory role in these processes by inhibiting ventral tegmental area (VTA) reward signals to the nucleus accumbens (NAc) following pain and loss. 3) THC, a major component of cannabis, exerts its psychoactive analgesic effects by binding to cannabinoid 1 receptors in the reward and pain systems, including the anterior cingulate (ACC), periaqueductal gray (PAG), thalamus, amygdala, VTA, NAc, and Hb, creating temporary relief of mood and pain symptoms but resulting in long-term alterations in reward circuitry that exacerbate depression and substance use. 4) Capitalizing on improvements in fMRI resolution, our novel imaging methods overcome prior technical constraints to study the Hb and other small structures critical to reward and pain processing.We will 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. Investigators will utilize a 2×2 factorial design: 1) 70 depressed cannabis users; 2) 70 depressed cannabis non-users; 3) 70 non-depressed cannabis users; and 4) 70 non-depressed cannabis non-users. To capture a wide range of illness severity, investigators will include subthreshold depression and cannabis use on ≥20 days of the past 30 days. Comprehensive clinical evaluations, a computerized reward task, and blood tests for CD4+ count, VL, and serum THC will be performed at baseline, 6- and 12 months. fMRI (resting-state, RFT, RPET, pain task) and cognitive tests will be done at baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiv, Depression, Cannabis Use Disorder

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
2x2 neuroimaging study
Masking
None (Open Label)
Masking Description
No masking, all participants will undergo the same procedures
Allocation
N/A
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PLWH
Arm Type
Other
Arm Description
All participants will undergo neuroimaging and behavioral tests.
Intervention Type
Other
Intervention Name(s)
MRI study - everyone scanned.
Intervention Description
This is an observational study without an intervention.
Primary Outcome Measure Information:
Title
Addiction Severity Index (ASI)
Description
Tool widely used in the evaluation of substance use treatment. It looks at history, frequency, and consequences of alcohol and drug use.
Time Frame
Baseline
Title
Montgomery Asberg Depression Rating Scale (MADRS) Scale 0-60 higher more severe
Description
Measures the severity of depressive episodes in patients with mood disorders
Time Frame
Baseline
Title
Temporal Experience of Pleasure Scale (TEPS) 25 to 120 higher more pleasure
Description
Self-report measure allowing the assessment of anticipatory and consummatory pleasure
Time Frame
Baseline
Title
neural circuitry underling reward and pain
Description
fMRI based tasks to measure brain activation during reward and pain processes
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Daily Sessions Frequency Age Quantity of Cannabis Use Inventory (DFAQ- CU) Score range 0 to 185. The higher the score, the greater the usage of cannabis.
Description
Measures cannabis consumption
Time Frame
Baseline
Title
Daily sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ- CU) Score range 0 to 185. The higher the score, the greater the usage of cannabis.
Description
Measures cannabis consumption
Time Frame
6 months
Title
Daily sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ- CU) Score range 0 to 185. The higher the score, the greater the usage of cannabis.
Description
Measures cannabis consumption
Time Frame
12 months
Title
Time Flowback (TLFB) Higher the score the greater the use.
Description
Tool to obtain a variety of quantitative estimates of marijuana, cigarette, and other drug use.
Time Frame
Baseline
Title
Time Flowback (TLFB) Higher the score the greater the use.
Description
Tool to obtain a variety of quantitative estimates of marijuana, cigarette, and other drug use.
Time Frame
6 month
Title
Time Flowback (TLFB) Higher the score the greater the use.
Description
Tool to obtain a variety of quantitative estimates of marijuana, cigarette, and other drug use.
Time Frame
12 month
Title
THC Metabolite, Serum
Description
Suggests use of, or exposure to, a product containing THC.
Time Frame
Baseline
Title
THC Metabolite, Serum
Description
Suggests use of, or exposure to, a product containing THC.
Time Frame
6 month
Title
THC Metabolite, Serum
Description
Suggests use of, or exposure to, a product containing THC.
Time Frame
12 month
Title
Fagerstrom test of nicotine dependence
Description
Examines physical intensity of addiction to nicotine
Time Frame
Baseline
Title
Fagerstrom test of nicotine dependence
Description
Examines physical intensity of addiction to nicotine
Time Frame
6 month
Title
Fagerstrom test of nicotine dependence
Description
Examines physical intensity of addiction to nicotine
Time Frame
12 month
Title
Beck Depression Inventory-II (BDI-II) Score 0-63 higher the score greater the depression
Description
Designed to assess the presence and severity of depressive symptoms
Time Frame
Baseline
Title
Beck Depression Inventory-II (BDI-II) Score 0-63 higher the score greater the depression
Description
Designed to assess the presence and severity of depressive symptoms
Time Frame
6 month
Title
Beck Depression Inventory-II (BDI-II) Score 0-63 higher the score greater the depression
Description
Designed to assess the presence and severity of depressive symptoms
Time Frame
12 month
Title
Snaith-Hamilton Pleasure Scale (SHAPS) Score 0-42 greater the score greater the pleasure.
Description
Measures anhedonia, the inability to experience pleasure.
Time Frame
Baseline
Title
Snaith-Hamilton Pleasure Scale (SHAPS) Score 0-42 greater the score greater the pleasure.
Description
Measures anhedonia, the inability to experience pleasure.
Time Frame
6 month
Title
Snaith-Hamilton Pleasure Scale (SHAPS) Score 0-42 greater the score greater the pleasure.
Description
Measures anhedonia, the inability to experience pleasure.
Time Frame
12 month
Title
AUDIT-C The higher the score the greater the alcohol use disorder.
Description
Identify persons who are hazardous drinkers or have active alcohol use disorders
Time Frame
Baseline
Title
AUDIT-C The higher the score the greater the alcohol use disorder.
Description
Identify persons who are hazardous drinkers or have active alcohol use disorders
Time Frame
6 month
Title
AUDIT-C The higher the score the greater the alcohol use disorder.
Description
Identify persons who are hazardous drinkers or have active alcohol use disorders
Time Frame
12 month
Title
CUPIT The higher the score the more problematic the use.
Description
Measures risky and problematic cannabis use.
Time Frame
Baseline
Title
CUPIT The higher the score the more problematic the use.
Description
Measures risky and problematic cannabis use.
Time Frame
6 month
Title
CUPIT The higher the score the more problematic the use.
Description
Measures risky and problematic cannabis use.
Time Frame
12 month
Title
Pittsburgh sleep quality index Scores 0-24 higher the score greater sleep dysfunction
Description
Assesses sleep quality and disturbances over a month period
Time Frame
Baseline
Title
Pittsburgh sleep quality index Scores 0-24 higher the score greater sleep dysfunction
Description
Assesses sleep quality and disturbances over a month period
Time Frame
6 month
Title
Pittsburgh sleep quality index Scores 0-24 higher the score greater sleep dysfunction
Description
Assesses sleep quality and disturbances over a month period
Time Frame
12 month
Title
Addiction Severity Index (ASI)
Description
Tool widely used in the evaluation of substance use treatment. It looks at history, frequency, and consequences of alcohol and drug use.
Time Frame
6 months
Title
Addiction Severity Index (ASI)
Description
Tool widely used in the evaluation of substance use treatment. It looks at history, frequency, and consequences of alcohol and drug use.
Time Frame
12 months
Title
Montgomery Asberg Depression Rating Scale (MADRS) Scale 0-60 higher more severe
Description
Measures the severity of depressive episodes in patients with mood disorders
Time Frame
6 months
Title
Temporal Experience of Pleasure Scale (TEPS) 25 to 120 higher more pleasure
Description
Self-report measure allowing the assessment of anticipatory and consummatory pleasure
Time Frame
6 months
Title
Brief Pain Inventory (BPI) The higher the score the greater the pain severity and impairment on functioning.
Description
Assesses the severity of pain and its impact on functioning.
Time Frame
6 months
Title
Brief Pain Inventory (BPI) The higher the score the greater the pain severity and impairment on functioning.
Description
Assesses the severity of pain and its impact on functioning.
Time Frame
12 months
Title
Temporal Experience of Pleasure Scale (TEPS) 25 to 120 higher more pleasure
Description
Self-report measure allowing the assessment of anticipatory and consummatory pleasure
Time Frame
12 months
Title
Pain Anxiety Symptom Scale (PASS-20) Range 0-100 higher the more anxiety symptoms
Description
Measures fear and anxiety responses specific to pain.
Time Frame
6 months
Title
HIV RNA test 20 to 10,000,000 copies/mL higher the amount the more infectious
Description
HIV RNA test detects HIV and not antibodies
Time Frame
Baseline
Title
CD4+ CD8+
Description
Monitors the immune system
Time Frame
Baseline
Title
CD4+ CD8+
Description
Monitors the immune system
Time Frame
6 months
Title
CD4+ CD8+
Description
Monitors the immune system
Time Frame
12 months
Title
Montgomery Asberg Depression Rating Scale (MADRS) Range 0-60 higher more severe
Description
Measures the severity of depressive episodes in patients with mood disorders
Time Frame
12 months
Title
Brief Pain Inventory (BPI) The higher the score the greater the pain severity and impairment on functioning.
Description
Assesses the severity of pain and its impact on functioning.
Time Frame
Baseline
Title
Pain Anxiety Symptom Scale (PASS-20) Range 0-100 higher the more anxiety symptoms
Description
Measures fear and anxiety responses specific to pain.
Time Frame
12 months
Title
Pain Anxiety Symptom Scale (PASS-20) Range 0-100 higher the more anxiety symptoms
Description
Measures fear and anxiety responses specific to pain.
Time Frame
Baseline
Title
HIV Visual Analogue Scale (HIV-VAS) 0-30 higher score worse pain
Description
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.
Time Frame
12 month
Other Pre-specified Outcome Measures:
Title
Internalized Stigma HIV Score range 40-160 higher then greater the stigma and negative internal thoughts
Description
Looks at a person living with HIV experiences and negative feelings or thoughts about their HIV status.
Time Frame
Baseline
Title
Internalized Stigma HIV Score range 40-160 higher then greater the stigma and negative internal thoughts
Description
Looks at a person living with HIV experiences and negative feelings or thoughts about their HIV status.
Time Frame
6 month
Title
Internalized Stigma HIV Score range 40-160 higher then greater the stigma and negative internal thoughts
Description
Looks at a person living with HIV experiences and negative feelings or thoughts about their HIV status.
Time Frame
12 month
Title
Anxiety Sensitivity Index (ASI) Range 0-74 Higher the score the greater and diverse amount of concerns a participant has about their anxiety.
Description
Different concerns someone could have regarding their anxiety.
Time Frame
Baseline
Title
Anxiety Sensitivity Index (ASI) Range 0-74 Higher the score the greater and diverse amount of concerns a participant has about their anxiety.
Description
Different concerns someone could have regarding their anxiety.
Time Frame
6 month
Title
Anxiety Sensitivity Index (ASI) Range 0-74 Higher the score the greater and diverse amount of concerns a participant has about their anxiety.
Description
Different concerns someone could have regarding their anxiety.
Time Frame
12 month
Title
The Beck Anxiety Inventory (BAI) Range 0-63. Higher the score the greater the intensity of anxiety.
Description
Assess the intensity of physical and cognitive anxiety symptoms during the past week.
Time Frame
Baseline
Title
The Beck Anxiety Inventory (BAI) Range 0-63. Higher the score the greater the intensity of anxiety.
Description
Assess the intensity of physical and cognitive anxiety symptoms during the past week.
Time Frame
6 month
Title
The Beck Anxiety Inventory (BAI) Range 0-63. Higher the score the greater the intensity of anxiety.
Description
Assess the intensity of physical and cognitive anxiety symptoms during the past week.
Time Frame
12 month
Title
Multidimensional Scale of Perceived Social Support (MSPSS) Range 0-60 Higher the score the greater the perceived social support.
Description
Measure of perceived adequacy of social support from three sources.
Time Frame
Baseline
Title
Multidimensional Scale of Perceived Social Support (MSPSS) Range 0-60 Higher the score the greater the perceived social support.
Description
Measure of perceived adequacy of social support from three sources.
Time Frame
6 month
Title
Multidimensional Scale of Perceived Social Support (MSPSS) Range 0-60 Higher the score the greater the perceived social support.
Description
Measure of perceived adequacy of social support from three sources.
Time Frame
12 month
Title
Life Events Checklist (LEC) - higher number greater trauma
Description
A measure of exposure to potentially traumatic events., higher number greater trauma
Time Frame
Baseline
Title
Life Events Checklist (LEC)- higher number greater trauma
Description
A measure of exposure to potentially traumatic events
Time Frame
12 month
Title
3-item R-UCLA Loneliness Scale Range 3-9. Higher the lonelier a participant feels
Description
Measures three dimensions of loneliness.
Time Frame
Baseline
Title
3-item R-UCLA Loneliness Scale Range 3-9. Higher the lonelier a participant feels
Description
Measures three dimensions of loneliness.
Time Frame
12 month
Title
Patient-Reported Outcome Measurement Information System (PROMIS-10) Range 10-50 Higher the score the better a participant scores their overall wellbeing.
Description
A set of person-centered measures that evaluates and monitors physical, mental, and social health.
Time Frame
Baseline
Title
Urban Life Stress Scale Range 21-105. Greater the number the worse the potential sources of stress.
Description
Measures community-level stressors as potential sources of psychological and emotional stress.
Time Frame
Baseline
Title
Beck Scale for Suicide Ideation (BSSI) Range 0-38 Higher the score the greater the suicide ideation.
Description
Instrument for detecting and measuring the current intensity of the patients' specific attitudes, behaviors, and plans to commit suicide during a specific time period.
Time Frame
Baseline
Title
Beck Scale for Suicide Ideation (BSSI) Range 0-38 Higher the score the greater the suicide ideation
Description
Instrument for detecting and measuring the current intensity of the patients' specific attitudes, behaviors, and plans to commit suicide during a specific time period.
Time Frame
6 month
Title
Beck Scale for Suicide Ideation (BSSI) Range 0-38 Higher the score the greater the suicide ideation
Description
Instrument for detecting and measuring the current intensity of the patients' specific attitudes, behaviors, and plans to commit suicide during a specific time period.
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV seropositivity confirmed with lab report, medical records, or HIV testing. Between the ages of 18-34 years Fluency in English or Spanish Ability to provide informed consent and perform study procedures, including estimated full-scale IQ >75 to ensure that participants are able to understand the study. Cannabis users: To capture a wide range of cannabis use frequency, meeting DSM-5 criteria for 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 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: • 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vilma Gabbay, MD
Phone
718-839-7549
Email
vilma.gabbay@einsteinmed.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Zoe Baker
Phone
5169624441
Email
zoe.baker@einsteinmed.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vilma Gabbay, MD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vilma Gabbay, MD, MS
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoe Baker
Phone
516-962-4441
Email
zoe.baker@einsteinmed.edu
First Name & Middle Initial & Last Name & Degree
Joanna Starrels, MD
First Name & Middle Initial & Last Name & Degree
Anjali Sharma, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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