Cultural Adaptation of Contingency Management for Black Adults With Stimulant Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Percent negative urine samples
研究概览
简要总结
The purpose of this study is to develop a culturally adapted contingency management (CM) protocol for Black adults with stimulant use disorder.
详细描述
This project seeks to develop a culturally adapted Contingency Management (CM) intervention for Black adults with stimulant use disorder (StUD). CM is grounded in behavioral economics and involves the use of tangible positive reinforcements to incentivize verifiable pro-health behaviors. There has been a recent surge in fatal stimulant related drug overdoses in the Black community. Black adults in the United States have been experiencing faster rates of overdose deaths, with a rate of 49.5/100,000 in 2022 (1.4 times the rate among White Americans). A resurgence in stimulant use, contamination of community drug supplies with high potency synthetic opioids (HPSO) and a range of structural and social vulnerabilities are major drivers of this unfortunate trend. CM has been shown to be the most effective intervention for StUD as there are no FDA approved medications for this indication. Emerging evidence shows that Black adults who entered treatment with cocaine-positive urines did not show any gains in treatment retention or other clinical outcomes. This observation of disparate health outcomes has informed the urgency to culturally adapt CM for Black population which is at heightened risk given the opioids/stimulant polysubstance fatal overdose.
The objective of this research is to develop components of a culturally adapted CM using theoretically and empirically driven approaches. Specific research aims include: 1) Assessment of the target population's behavioral risks, perceived need for prevention, barriers, preferences for intervention and development of components of CM adaptation; 2) production of iterative drafts of the adapted CM and 3.) Pilot randomized controlled trial to examine the short-term efficacy of the adapted CM with the primary outcomes of percent negative urines and longest duration of abstinence during treatment. Aim 3 consists of PI training to deliver the culturally adapted treatment and the culturally adapted treatment will be piloted with the community that the treatment was adapted for over 12 weeks, twice weekly, with a 4 week lead-in phase.
Aims 1 and 2 are Observational aims not requiring registration that will inform Aim 3.
The focus of this registration is Aim 3.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants must self-identify as Black/African American
- •DSM-5 diagnosis of stimulant use disorder in the past month (30 days)
排除标准
- •individuals who are intoxicated or otherwise unable to provide consent
研究组 & 干预措施
Basic CM
Participants in this arm will receive the basic CM over a 12- week treatment period
干预措施: Basic Contingency Management (CM) (Behavioral)
Standard Care Condition
Intensive Outpatient clinic (IOP) at substance use treatment and addiction (SATU) clinic twice every week, one day for group and the other for individual counseling
Culturally Adapted CM
Participants in this arm will receive the culturally adapted CM over a 12- week treatment period
干预措施: Cultually Adapted Contingency Management (CM) (Behavioral)
结局指标
主要结局
Percent negative urine samples
时间窗: Week 12
Participants will provide urine samples twice weekly. Percent of negative urines provided will be calculated.
Mean longest duration of abstinence
时间窗: Week 12
The longest duration of abstinence in days will be measured.
次要结局
- Mean treatment retention(Baseline and Week 12.)
- Acceptability of Intervention Measure (AIM)(Week 12)
- Feasibility of Intervention Measure (FIM)(Week 12)
- Client Satisfaction Questionnaire (CSQ-8)(Week 12)