Implementing a Contingency Management Program Addressing Methamphetamine Use for and With the People of Hawai'i (2025-2026)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Treatment Effectiveness Assessments (TEA) at 6- and 12-weeks post-enrollment
研究概览
简要总结
This clinical trial is to implement contingency management (CM) as an intervention tool to address methamphetamine use and will be initiated during inpatient acute hospitalization in trauma injured patients.
The goals are:
- Gather effectiveness data on a CM program for participants in Hawaii who use methamphetamine during hospitalization and following discharge due to trauma injury
- To assess participant perspectives on engaging with a CM program based at a Level 1 Trauma Center. Researches will assess both patient-reported and biologically-confirmed medium-term program effectiveness and conduct qualitative interviews with participants post-program.
- To assess the rate of leaving against medical advice (AMA) and treatment completion in acute hospital setting in participants.
- To assess the optimal timing of CM initiation for traumatically injured hospitalized patients by comparing patient outcomes (i.e. duration of CM participation and rates of CM program completion and providing negative urine samples) to NCT06532370 where CM was initiated after discharge from the hospital.
For total of 12 weeks, participants will:
- Be visited on Mondays/Thursdays or Tuesdays/Fridays by the research team to complete urine analysis during the hospitalization
- Visit a follow up clinic up to 2 times per week on Mondays/Thursdays or Tuesdays/Fridays to complete urinalysis following discharge from the hospital
- Complete Treatment Effectiveness Assessments at 6 and 12 weeks
- Engage in qualitative interview at the end of the CM program
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted trauma patients
- •Age greater than 18 years old
- •Urine drug screen positive for methamphetamines during the current hospitalization
- •Report at least weekly methamphetamine use
- •First methamphetamine use greater than 6 months prior to injury
- •Report at least 4 Diagnostic and Statistical Manual of Mental Disorders 5th Edition, Amphetamine-Type Substance Use Disorder symptoms (at least moderate disease)
- •Glasgow Coma Scale ≥13 upon arrival to the emergency department
- •Ability to understand and participate in study procedures
- •Ability to communicate in English
- •Expected discharge date within 45 days on the day of screening / recruitment
排除标准
- •Active psychosis (reporting auditory or visual hallucinations)
- •Under ongoing cardiorespiratory monitoring
- •Evidence of moderate or severe traumatic brain injury
- •Patients who are known to be pregnant
- •Prisoners
- •Individuals incarcerated at the time of their hospitalization
- •Individuals lacking capacity to provide, or are otherwise unable or unwilling to provide written informed consent
研究组 & 干预措施
Contingency management intervention
Intervention is total of 12 weeks. During the hospitalization, participants will be visited by study personnel and will be asked to complete a urine drug screen that will screen for presence of methamphetamine on Mondays/Thursdays or Tuesdays/Fridays (M/Th or T/F). Once discharged, participants will be asked to come into the out patient clinic 2 times per week (M/Th or T/F) to complete a urine drug screen that will screen for presence of methamphetamine. If the specimen is negative for methamphetamine, the participants will be rewarded. Participants will also be asked to complete the Treatment Effectiveness Assessment (TEA) with study personnel.
干预措施: Contingency management (Behavioral)
结局指标
主要结局
Treatment Effectiveness Assessments (TEA) at 6- and 12-weeks post-enrollment
时间窗: From enrollment to 6 and 12 weeks
TEA (Treatment Effectiveness Assessment) at 6- and 12-weeks post-enrollment to assess both patient-reported medium-term program effectiveness. TEA asks individuals to respond to changes in four domains following a drug treatment program: Substance use, health, lifestyle, and community. The score for each domain can range from 1 (no change or not much) to 10 (much better), for total score of 4-40. This score allows for the prioritization of each participants values, and therefore does not require strict abstinence to demonstrate benefit from drug treatment.
次要结局
- Conduct qualitative interviews with participants post-program(At the end of the treatment at 12 weeks)