Contingency Management for Alcohol Use Disorder
- Conditions
- Alcohol Use Disorder
- Interventions
- Behavioral: DynamiCare Rewards
- Registration Number
- NCT03701204
- Lead Sponsor
- DynamiCare Health
- Brief Summary
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)
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
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.
• Participants must not currently be suicidal or actively psychotic, by clinician judgement.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DynamiCare Rewards DynamiCare Rewards The study will test the feasibility/acceptability and efficacy of DynamiCare Rewards™. DynamiCare Rewards is an iOS/Android app which automates Contingency Management (CM) to help the patient self-monitor and focus attention on his/her behavioral goals (i.e., abstinence) for alcohol or other substance use disorders.
- Primary Outcome Measures
Name Time Method 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) 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.
- Secondary Outcome Measures
Name Time Method 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 Groups will be compared using Generalized Estimating Equation (GEE) analysis on the percent of participants abstinent over time at each time point.
Longest continuous period of abstinence from alcohol and from drugs and alcohol 12-week intervention period Groups will be compared using GEE analysis on the percent of participants abstinent over time at each time point.
Retention in treatment 12-week intervention period Groups will be compared on the number of days retained in treatment according to the site's Electronic Health Record data, and also on the graduation rate from treatment vs. leaving against medical advice.
Trial Locations
- Locations (2)
Gosnold on Cape Cod
🇺🇸Centerville, Massachusetts, United States
Gosnold
🇺🇸Falmouth, Massachusetts, United States