A Systematic Medical Approach to Reward Transformation (SMART) for Brain Health in Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Addiction Severity Index (ASI)
研究概览
简要总结
The investigators hypothesize that opioid use in African-Americans will be associated with hypodopaminergic alleles that alter the threshold for activating feelings of reward and pleasure within the dopaminergic system, and that these allelic frequencies will differ significantly from European Americans. Planned is a targeted system to study genetic risks for reward deficiency using risk gene panel to assign a genetic addiction risk score (GARS), comprehensive surveys to determine quality of life and exposure to stressors and trauma. This system will allow prediction of addiction and relapse potential and delivery of personalized treatment.
详细描述
Individuals seeking treatment for Opioid Use Disorder in the Washington DC metro area will be recruited to this Study, which consists of 1) early pre-disposition diagnosis using the Genetic Addiction Risk Score (GARS); 2) Assessment of reward deficiency, co-morbid neuropsychiatric disease, quality of life/happiness, stressors/trauma and other psychometric measurements using validated questionnaires; Urine drug testing during actual treatment that uses comprehensive analysis of reported drugs to determine compliance with prescription medications and non-abstinence to illicit drugs; and 4) adjunctive treatment with neuroadaptogen amino acid therapy (NAAT), a glutaminergic-dopaminergic optimization nutraceutical (generic name: KB220) compared to placebo, aimed to prevent relapse by induction of dopamine homeostasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be able to consent and understand questions being asked during surveys
- •Must be willing to undergo pharmacogenetic testing
- •Must be able to swallow tablets
排除标准
- •Clinical Diagnosis of Alzheimer's disease/Dementia
- •Clinical Diagnosis of Schizophrenia
- •Clinical Diagnosis of a terminal disorder
研究组 & 干预措施
Nutraceutical, KB220Z
A nutraceutical pill containing pro-dopamine precursors
干预措施: KB220Z (Dietary Supplement)
Placebo
A placebo that looks the same and is in a similar bottle
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Addiction Severity Index (ASI)
时间窗: 4 months
Change in indices associated with addiction and associated behaviors
Drug Relapse
时间窗: 4 months
Number of times opioids and other types of drugs of abuse are detected in urine
Change in assessment of depression, anxiety, PTSD
时间窗: 4 months
Change from Baseline in from the Comprehensive Universal Behavioral Screen for depression, anxiety, PTSD, after 4 months
Change in Reward Deficiency Syndrome Questionnaire (RDSQ)
时间窗: 4 months
Change in risky behaviors
Vitamin B6 testing
时间窗: Month 4
Presence of B6 in blood to test for compliance with Nutraceutical
Genetic Testing for the number of risk alleles for Reward Genes through GARS
时间窗: Month 1
Number of reward gene variants in opioid use disorder patients compared to controls
次要结局
未报告次要终点
研究者
Marjorie Gondre-Lewis
Professor
Howard University