Integrating Contingency Management Into Routine Care for Alcohol Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 4
- 主要终点
- Percent of participants abstinent from alcohol at each monthly assessment time point (negative urine test and self-report of no use in past 30 days)
研究概览
简要总结
Randomized pilot study of a device (smartphone app) that poses non-significant risk to participants and is exempt from Investigational Device Exemption regulations [21 Code of Federal Regulations 812.2(c)
详细描述
To test the feasibility/acceptability and efficacy of a minimum viable product (MVP) of a smartphone app for patients with alcohol use disorder who are in active treatment and recovery to perform self-tracking of their recovery behavior (e.g., abstinence) and focus on their motivation to maintain their desired health behaviors (i.e., abstinence).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Participants in the pilot study will be 60 new intakes to Gosnold's outpatient Substance Use Disorder (SUD) program who:
- •are >18 years old;
- •meet DSM-5 criteria for current (past year) alcohol use disorder, at least moderate severity;
- •identify alcohol as the primary drug problem;
- •Currently use alcohol (past 7 days) or have been in treatment 14 days or less and used alcohol within 7 days of treatment entry;
- •have and use an Android or iOS smartphone with acceptable
- •capability;
- •are willing to participate in home testing and use of the smartphone,
- •speak and read the English language adequately to understand smartphone commands and responses and
- •are willing to be randomly assigned to receive treatment with or without the smartphone app as an added feature.
排除标准
- •Participants must not currently be suicidal or actively psychotic, by clinician judgement.
结局指标
主要结局
Percent of participants abstinent from alcohol at each monthly assessment time point (negative urine test and self-report of no use in past 30 days)
时间窗: 12-week intervention period
The pilot efficacy study will utilize alcohol abstinence at each assessment time point as the primary outcome. This is defined as a negative ethyl glucuronide urine test (witnessed) at the monthly assessment time points and self-report of no alcohol use in the past 30 days.
次要结局
- Percent of participants abstinent from all drugs at each monthly assessment time point (negative urine test and self-report of no use in past 30 days)(12-week intervention period)
- Longest continuous period of abstinence from alcohol and from drugs and alcohol(12-week intervention period)
- Retention in treatment(12-week intervention period)
研究者
Eric Gastfriend
Principal Investigator
DynamiCare Health