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Completed

NCT Number: NCT03701204

Contingency Management 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)

Completed

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gosnold on Cape Cod, Centerville, Massachusetts, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DynamiCare Rewards

Behavioral

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 outcomes

  1. 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)

    Time frame: 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 outcomes

  1. 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)

    Time frame: 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.

  2. Longest continuous period of abstinence from alcohol and from drugs and alcohol

    Time frame: 12-week intervention period

    Groups will be compared using GEE analysis on the percent of participants abstinent over time at each time point.

  3. Retention in treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

DynamiCare Health

Industry

Collaborators

  • Johns Hopkins University

Registry information

Official study title

Integrating Contingency Management Into Routine Care for Alcohol Use Disorder

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2018
Registry last updated
Aug 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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