search
Back to results

Contingency Management for Alcohol Use Disorder

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DynamiCare Rewards
Sponsored by
DynamiCare Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gosnold on Cape Cod
  • Gosnold

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DynamiCare Rewards

Control

Arm Description

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.

Treatment as usual

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 7, 2018
Last Updated
August 10, 2020
Sponsor
DynamiCare Health
Collaborators
Johns Hopkins University
search

1. Study Identification

Unique Protocol Identification Number
NCT03701204
Brief Title
Contingency Management for Alcohol Use Disorder
Official Title
Integrating Contingency Management Into Routine Care for Alcohol Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 8, 2018 (Actual)
Primary Completion Date
August 21, 2019 (Actual)
Study Completion Date
August 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
DynamiCare Health
Collaborators
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DynamiCare Rewards
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
DynamiCare Rewards
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
12-week intervention period
Secondary Outcome Measure Information:
Title
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)
Description
Groups will be compared using Generalized Estimating Equation (GEE) analysis on the percent of participants abstinent over time at each time point.
Time Frame
12-week intervention period
Title
Longest continuous period of abstinence from alcohol and from drugs and alcohol
Description
Groups will be compared using GEE analysis on the percent of participants abstinent over time at each time point.
Time Frame
12-week intervention period
Title
Retention in treatment
Description
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.
Time Frame
12-week intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Gastfriend, MBA
Organizational Affiliation
DynamiCare Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gosnold on Cape Cod
City
Centerville
State/Province
Massachusetts
ZIP/Postal Code
02632
Country
United States
Facility Name
Gosnold
City
Falmouth
State/Province
Massachusetts
ZIP/Postal Code
02540
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We intend to make participant data available by request as long as it is unidentifiable.

Learn more about this trial

Contingency Management for Alcohol Use Disorder

We'll reach out to this number within 24 hrs