Smartphone-based Services for People Diagnosed With Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Independent lab-based salivary drug toxicology for abstinence from all unprescribed drugs (initial 16 weeks)
研究概览
简要总结
The purpose of the research is to check whether services and materials made available through a smartphone app are helpful to people who have been diagnosed with opioid use disorder (OUD). Participants are asked to use an app to submit videos of themselves taking salivary drug tests to a secure online system. The app includes reminders, rewards, and activities, as well as access to live support. Study participation lasts one year and includes about 30 minutes each week submitting videos, an hour-long interview to get started, and hour-long interviews once every three months after that over the course of the year.
详细描述
Purpose of the Study
The purpose of the study is to evaluate the safety, clinical effectiveness, and cost effectiveness of the standard DynamiCare Health smartphone-smartcard platform as a means of promoting health and recovery for patients who are seeking treatment for problem opioid use.
Experimental Design
This is a prospective parallel randomized controlled trial with two study arms. The experimental group receives a smartphone-based program that includes incentives contingent upon drug abstinence and treatment attendance, access to a contingency management (CM) Guide who provides measurement-based peer coaching grounded in Community Reinforcement Approach, and self-paced Cognitive Behavioral Therapy (CBT) modules. The control group receives a smartphone-based sham program that includes incentives for submission of self-conducted salivary toxicology tests.
Welcome Period
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Investigators who have no direct contact with study participants will communicate directly with information technology (IT) staff to assign participants to one of the two study groups. Participants will be blind to hypothesis, and outcome assessors will be completely blind. Care providers (i.e., "Contingency Management [CM] Guides") cannot be blind because modified scripts are required for their interactions with participants depending on group assignment.
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
- •Aged 18 or older
- •Lives in the United States
- •Read and speak English fluently
- •Owns a smartphone compatible with the DynamiCare app (e.g., Apple or Android)
- •Diagnosed with opioid use disorder or attests to having problem opioid use
- •Has used unprescribed opioids within the prior 30 days
- •Has, or is willing to accept, an appointment to initiate medication assisted treatment or has initiated medication assisted treatment in the prior 45 days
- •Must have an ASAM CO-Triage score between L1 and L3.1
排除标准
- •Is currently enrolled in another study involving substance abuse treatment
- •Has concurrent alcohol use disorder
- •Is currently incarcerated
- •Has current suicidal ideation or overt psychosis
研究组 & 干预措施
Abstinence reinforcement
Participants earn incentives for submission of salivary drug toxicology video selfies that show test results consistent with the goals of treatment. Goals are abstinence-based (i.e., relate to which tested substances should be negative on the test given the medications that the particular participant has been prescribed). Incentives are also provided for attendance at treatment-related appointments and for completion of self-paced cognitive behavior therapy modules available via the smartphone app.
干预措施: Contingency management (Behavioral)
Abstinence reinforcement
Participants earn incentives for submission of salivary drug toxicology video selfies that show test results consistent with the goals of treatment. Goals are abstinence-based (i.e., relate to which tested substances should be negative on the test given the medications that the particular participant has been prescribed). Incentives are also provided for attendance at treatment-related appointments and for completion of self-paced cognitive behavior therapy modules available via the smartphone app.
干预措施: Cognitive-Behavior Therapy Modules (Behavioral)
Abstinence reinforcement
Participants earn incentives for submission of salivary drug toxicology video selfies that show test results consistent with the goals of treatment. Goals are abstinence-based (i.e., relate to which tested substances should be negative on the test given the medications that the particular participant has been prescribed). Incentives are also provided for attendance at treatment-related appointments and for completion of self-paced cognitive behavior therapy modules available via the smartphone app.
干预措施: Peer Contingency Management (CM) Guide (Behavioral)
Sample-contingent control
Identical to the experimental group except that incentives are available only for submission of selfie-videos that show test results, without regard to the results of the salivary drug toxicology test. Similarly, incentives are not provided for appointments or completion of wellness modules.
干预措施: Drug testing (Behavioral)
Sample-contingent control
Identical to the experimental group except that incentives are available only for submission of selfie-videos that show test results, without regard to the results of the salivary drug toxicology test. Similarly, incentives are not provided for appointments or completion of wellness modules.
干预措施: Wellness modules (Behavioral)
Sample-contingent control
Identical to the experimental group except that incentives are available only for submission of selfie-videos that show test results, without regard to the results of the salivary drug toxicology test. Similarly, incentives are not provided for appointments or completion of wellness modules.
干预措施: Peer technical support (Behavioral)
结局指标
主要结局
Independent lab-based salivary drug toxicology for abstinence from all unprescribed drugs (initial 16 weeks)
时间窗: Initial 16 weeks
Abstinence from all unprescribed drugs as measured by independent, lab-based salivary toxicology testing (Y/N) collected every 4 weeks throughout the initial 16-week Study Period.
次要结局
- Medications for Opioid Use Disorder (MOUD) participation(48 weeks)
- Days of Medications for Opioid Use Disorder (MOUD) adherence(48 weeks)
- Frequency of Adverse Events(48 weeks)
- Healthcare utilization(48 weeks)
- Lab-based salivary drug toxicology for abstinence from all unprescribed drugs (weeks 17-48)(Weeks 17-48)