Tech-Enabled CM for AUD at Scale

NCT04581499 | Completed DMC

• 3 other identifiers: DCH0022R44AA026234-025R44AA026234-03
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Use Disorder; Alcohol Dependence; Drug Dependence

Keywords

contingency management; motivational incentives; cognitive behavioral therapy; CBT; recovery; recovery coach; recovery coaching; telehealth; digital therapeutic; remote monitoring; drug testing; breathalyzer; Medicaid; alcoholism; alcohol abuse; addiction

Outcome Measures

Primary Outcomes (1)

• Alcohol Use

  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 Outcomes (4)

• Engagement

  32 weeks

• Retention

  32 weeks

• Drug Use Clinical Effectiveness

  32 weeks

• Cost-effectiveness

  12 months

Study Arms (2)

DynamiCare Motivation Support Program

EXPERIMENTAL

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

Untreated or Routine Care Control Group

OTHER

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

Interventions

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.

DynamiCare Motivation Support Program

Untreated or Routine Care Control Group OTHER

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

Untreated or Routine Care Control Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All genders are eligible
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• DynamiCare Health: lead
• RAND: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

DynamiCare Health

Boston, Massachusetts, 02109, United States

Location

Related Links

• Press release describing study launch and Vermont Medicaid's Chief Medical Officer's rationale.

MeSH Terms

Conditions

Alcoholism; Substance-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Eric E Gastfriend, MBA

  DynamiCare Health Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Random-controlled trial

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: October 9, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2025
• Study Completion: June 30, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)