Tech-Enabled CM for AUD at Scale

June 26, 2023 updated by: DynamiCare Health

Applying Technology-Enabled Contingency Management for Alcohol Use Disorder at Scale

This Phase II Small Business Innovative Research (SBIR) project is a clinical effectiveness and cost-effectiveness random controlled trial (RCT) of DynamiCare Health's innovative smartphone/smart debit card remote digital coaching program, which integrates Contingency Management, Recovery Coaching, and cognitive behavioral therapy (CBT), to address alcohol use disorder (AUD) in 300 adults.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This application proposes to continue clinical effectiveness and cost-effectiveness testing of the DynamiCare Health platform. This is an innovative smartphone-based digital coaching program that offers remotely-delivered contingency management (CM), Recovery Coaching, and cognitive behavioral therapy (CBT) content to address alcohol use disorder (AUD). CM, which uses financial incentives to reward abstinence and treatment attendance, is one of the most effective, evidence-based, and overlooked intervention for substance use disorders (SUD). DynamiCare, through its remote delivery system, has addressed the logistical barriers to adoption, and now seeks, through this proposal, to drive payer adoption. Our Phase 1 preliminary data shows that the intervention is acceptable and can be highly effective when delivered as a supplemental therapy to persons with AUD enrolled in treatment. Phase 2 proposes to partner with Medicaid to deploy and test the fully developed intervention in an RCT among individuals with AUD (n=300). Our goals are to: 1) Deploy the DynamiCare CM and digital coaching program at scale among Medicaid members with AUD; 2) determine clinical effectiveness; and 3) evaluate the cost-effectiveness and return-on-investment from the payer perspective. This study design addresses a lack in the CM literature of empirical evidence on the cost-savings for payers from CM. If CM can be shown to create cost-savings for payers, the final barrier to widespread adoption would fall. Overall, this Phase 2 project, which follows a highly successful Phase 1, will provide critical data to advance the utility of this innovative digital platform as it is deployed in the real world to help the millions of people with AUD.

Study Type

Interventional

Enrollment (Actual)

236

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02109
        • DynamiCare Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants in the study must have Alcohol Use Disorder (AUD) and:

  1. Be >18 years old
  2. Meet the DSM-5 criteria for current (past year) AUD, or be recommended for care in the ASAM CO-Triage assessment
  3. Have consumed at least one alcoholic beverage within the last 10 days, according to self-report
  4. Speak English
  5. Have an Android or iOS smartphone.

Exclusion Criteria:

  1. Participants with current suicidal intent will be excluded as they require a higher level of care that cannot be provided by DynamiCare and our Recovery Coaches (hence, these individuals will be directly referred for clinical evaluation).
  2. Participants with ASAM CO-Triage level needs higher than Level 3.1 (e.g., greater than community-based, working halfway house) and not receiving addiction treatment will be excluded because they require inpatient treatment. Once the participant has received treatment, Recovery Coaches will reach out again to re-enroll the participant in the study if the participant wishes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DynamiCare Motivation Support Program
Intervention Group members will receive 32 weeks of remote Contingency Management (CM; financial motivational incentives), Recovery Coaching, substance testing, appointment reminding/tracking, and in-app Cognitive Behavioral Therapy (CBT). After 32 weeks, coaching, testing, appointment tracking and CBT will continue until an overall 12 months in the project is completed.
Combination product: DynamiCare Motivation Support Program
DynamiCare is an evidence-based, multi-service platform that combines software, smartphone and pocket-sized alcohol and drug testing hardware, and recovery services, designed to remotely deliver evidence-based methodologies to facilitate people's motivation and accountability to overcome alcohol, nicotine and other drug use disorders, whether in formal treatment or not.
Other: Untreated or Routine Care Control Group
Control participants will receive substance tests at the same frequency as Intervention participants, and the same incentive amounts for tests as treatment participants. Controls' payments, however, will not be contingent on positive/negative results, but rather only on valid, on-time submission. Controls will not receive coaching, CBT or rewards for appointments.
Other: Untreated or Routine Care Control Group
No specific intervention, i.e., research participation plus any community-based treatment the individual seeks to obtain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol Use
Time Frame: 32 weeks
The primary outcome measure is alcohol use, in terms of the number of weeks of abstinence confirmed by DynamiCare Breathalyzer tests and self-report.
32 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engagement
Time Frame: 32 weeks
Percent of available funds earned as a composite measure.
32 weeks
Retention
Time Frame: 32 weeks
Monthly rates of retention in the program.
32 weeks
Drug Use Clinical Effectiveness
Time Frame: 32 weeks
Measured by DynamiCare saliva drug test results and weekly self-report.
32 weeks
Cost-effectiveness
Time Frame: 12 months
Medicaid healthcare utilization claims costs vs. prior 12 months.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DynamiCare Health

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
RAND

Investigators

  • Principal Investigator: Eric E Gastfriend, MBA, DynamiCare Health, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

October 5, 2020

First Posted (Actual)

October 9, 2020

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 26, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCH002
  • 2R44AA026234-02 (U.S. NIH Grant/Contract)
  • 5R44AA026234-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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