Tech-Enabled CM for AUD at Scale

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04581499
• Other study ID #: DCH002
• Secondary ID: 2R44AA026234-025
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: April 2024

Study information

• Verified date: June 2023
• Source: DynamiCare Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 236
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Drug Dependence
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	DynamiCare Health	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
DynamiCare Health	National Institute on Alcohol Abuse and Alcoholism (NIAAA), RAND

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

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