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Tech-Enabled CM for AUD at Scale in Medicaid

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ClinicalTrials.gov Identifier: NCT04581499
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : January 20, 2022
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
DynamiCare Health

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 adult Medicaid recipients.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Alcohol Dependence Drug Dependence Combination Product: DynamiCare Motivation Support Program Other: Untreated or Routine Care Control Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Random-controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Applying Technology-Enabled Contingency Management for Alcohol Use Disorder at Scale in a Medicaid Population
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

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.

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.

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All genders are eligible
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Medicaid members with Alcohol use Disorder (AUD)
  • At least 18 years old
  • Meet Diagnostic and Statistical Manual (DSM-5) criteria for current (past year) AUD, or recommended for care in the American Society of Addiction Medicine (ASAM) CO-Triage assessment
  • 3) Currently using: Have consumed at least one alcoholic beverage within the last 10 days, according to self-report, AND submits at least 1 positive substance test (breath or saliva) during the Welcome phase
  • Speaks English
  • Has an Android or IOS smartphone

Exclusion Criteria:

  • Current suicidal intent
  • ASAM CO-Triage Level of Care needs higher than Level 3.1 (e.g., greater than community-based, working halfway house) and not receiving addiction treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04581499

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Contact: David R Gastfriend, M.D. 855-539-6264 dgastfriend@dynamicarehealth.com

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United States, Massachusetts
DynamiCare Health Recruiting
Boston, Massachusetts, United States, 02109
Contact: DynamiCare Health         
Principal Investigator: Eric E Gastfriend, MBA         
Sponsors and Collaborators
DynamiCare Health
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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Principal Investigator: Eric E Gastfriend, MBA DynamiCare Health, Inc.
Additional Information:
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Responsible Party: DynamiCare Health
ClinicalTrials.gov Identifier: NCT04581499    
Other Study ID Numbers: DCH002
2R44AA026234-02 ( U.S. NIH Grant/Contract )
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: January 20, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by DynamiCare Health:
contingency management
motivational incentives
cognitive behavioral therapy
recovery coach
recovery coaching
digital therapeutic
remote monitoring
drug testing
alcohol abuse
Additional relevant MeSH terms:
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Substance-Related Disorders
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders