The Neural Underpinnings of Depression and Cannabis Use in Young People Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Neural Circuitry measured by MRI
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
No masking, all participants will undergo the same procedures
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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:
- •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.
研究组 & 干预措施
Neural Underpinnings of Depression Group
All participants will undergo neuroimaging and behavioral tests. during the course of the study (12 months).
干预措施: MRI Study (Behavioral)
结局指标
主要结局
Neural Circuitry measured by MRI
时间窗: Baseline
Measured using Magnetic Resonance Imaging. Summary beta values representing the level of brain activity will be calculated.
Addiction Severity Index (ASI)
时间窗: 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
时间窗: 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)
时间窗: Up to 12 months
Self-report measure allowing the assessment of anticipatory and consummatory pleasure 25 to 120 higher more pleasure
次要结局
- tetrahydrocannabinol (THC) Metabolite, Serum(Up to 12 months)
- Daily Sessions Frequency Age Quantity of Cannabis Use Inventory (DFAQ- CU)(Up to 12 months)
- Snaith-Hamilton Pleasure Scale (SHAPS)(Up to 12 months)
- HIV RNA test(Baseline)
- Beck Depression Inventory-II (BDI-II)(Up to 12 months)
- Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)(Up to 12 months)
- Cannabis Use Problem Identification Test (CUPIT)(Up to 12 months)
- Pittsburgh sleep quality index(up to 12 months)
- Brief Pain Inventory (BPI)(up to 12 months)
- Fagerström Test for Nicotine Dependence full-term normal delivery (FTND)(Up to 12 months)
- Pain Anxiety Symptom Scale (PASS-20)(up to 12 months)
- Timeline Followback (TLFB)(Up to 12 months)
- cluster of differentiation 4 (CD4+) / cluster of differentiation 8 (CD8+)(Up to 12 months)
- HIV Visual Analogue Scale (HIV-VAS)(12 month)
研究者
Vilma Gabbay
Professor
University of Miami