Contingency Management for Alcohol Use Disorder

NCT ID: NCT03701204

Last Updated: 2020-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-08

Study Completion Date

2019-08-21

Brief Summary

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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

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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).

Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

DynamiCare Rewards

Intervention Type BEHAVIORAL

Participants assigned to the DynamiCare Rewards group will receive the following:

1. App on their smartphone
2. Substance Testing Devices: BACTrack Mobile Pro - submits BAC results directly to smartphone via Bluetooth and Saliva Test Kits.
3. Next Step debit card to receive financial incentives
4. Participant will be prompted via the app to conduct breathalyzer/saliva tests, using the devices camera to take "selfie" photo/videos to prevent cheating.
5. 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.
6. The amount of coins and funds are available on a progressive variable reward schedule.

Control

Treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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DynamiCare Rewards

Participants assigned to the DynamiCare Rewards group will receive the following:

1. App on their smartphone
2. Substance Testing Devices: BACTrack Mobile Pro - submits BAC results directly to smartphone via Bluetooth and Saliva Test Kits.
3. Next Step debit card to receive financial incentives
4. Participant will be prompted via the app to conduct breathalyzer/saliva tests, using the devices camera to take "selfie" photo/videos to prevent cheating.
5. 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.
6. The amount of coins and funds are available on a progressive variable reward schedule.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role collaborator

DynamiCare Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Eric Gastfriend

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Gastfriend, MBA

Role: PRINCIPAL_INVESTIGATOR

DynamiCare Health

Locations

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Gosnold on Cape Cod

Centerville, Massachusetts, United States

Site Status

Gosnold

Falmouth, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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DCH001

Identifier Type: -

Identifier Source: org_study_id

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