Clinical Trials Directory

Trials / Completed

CompletedNCT04581499

Tech-Enabled CM for AUD at Scale

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
236 (actual)
Sponsor
DynamiCare Health · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
COMBINATION_PRODUCTDynamiCare Motivation Support ProgramDynamiCare 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.
OTHERUntreated or Routine Care Control GroupNo specific intervention, i.e., research participation plus any community-based treatment the individual seeks to obtain.

Timeline

Start date
2021-01-01
Primary completion
2025-01-01
Completion
2025-06-30
First posted
2020-10-09
Last updated
2025-10-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04581499. Inclusion in this directory is not an endorsement.