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OpenTrials
Completed

NCT Number: NCT04581499

Tech-Enabled CM for AUD 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DynamiCare Health

Boston, Massachusetts, 02109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

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

Exclusion criteria

  • 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).
  • 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

Treatment and study plan

DynamiCare Motivation Support Program

Combination Product

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.

Untreated or Routine Care Control Group

Other

No specific intervention, i.e., research participation plus any community-based treatment the individual seeks to obtain.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Engagement

    Time frame: 32 weeks

    Percent of available funds earned as a composite measure.

  2. Retention

    Time frame: 32 weeks

    Monthly rates of retention in the program.

  3. Drug Use Clinical Effectiveness

    Time frame: 32 weeks

    Measured by DynamiCare saliva drug test results and weekly self-report.

  4. Cost-effectiveness

    Time frame: 12 months

    Medicaid healthcare utilization claims costs vs. prior 12 months.

Sponsors and collaborators

Lead sponsor

DynamiCare Health

Industry

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • RAND

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 9, 2020
Registry last updated
Oct 2, 2025

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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