Contingency Management for Alcohol Use Disorder

Integrating Contingency Management Into Routine Care for Alcohol Use Disorder

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)

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Behavioral: DynamiCare Rewards

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).

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Centerville, Massachusetts, United States, 02632
      • Gosnold on Cape Cod
    • Falmouth, Massachusetts, United States, 02540
      • Gosnold

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

• Participants must not currently be suicidal or actively psychotic, by clinician judgement.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: DynamiCare Rewards; Participants assigned to the DynamiCare Rewards group will receive the following: App on their smartphone; Substance Testing Devices: BACTrack Mobile Pro - submits BAC results directly to smartphone via Bluetooth and Saliva Test Kits.; Next Step debit card to receive financial incentives; Participant will be prompted via the app to conduct breathalyzer/saliva tests, using the devices camera to take "selfie" photo/videos to prevent cheating.; Negative tests result in participant receiving electronic virtual "coins", which can be transferred from reserve account (reserve account inaccessible to participant) to the spendable Next Step debit card.; The amount of coins and funds are available on a progressive variable reward schedule.
No Intervention: Control; Treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	12-week intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Groups will be compared using Generalized Estimating Equation (GEE) analysis on the percent of participants abstinent over time at each time point.	12-week intervention period
Longest continuous period of abstinence from alcohol and from drugs and alcohol	Groups will be compared using GEE analysis on the percent of participants abstinent over time at each time point.	12-week intervention period
Retention in treatment	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.	12-week intervention period

Collaborators and Investigators

• Sponsor: DynamiCare Health
• Collaborators: Johns Hopkins University
• Investigators: Principal Investigator: Eric Gastfriend, MBA, DynamiCare Health

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2018
• Primary Completion (Actual): August 21, 2019
• Study Completion (Actual): August 21, 2019

Study Registration Dates

• First Submitted: October 7, 2018
• First Submitted That Met QC Criteria: October 7, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism
• Other Study ID Numbers: DCH001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: We intend to make participant data available by request as long as it is unidentifiable.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No