Tech-Enabled CM for AUD at Scale in Medicaid
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04581499|
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : May 21, 2021
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Random-controlled trial|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- Engagement [ Time Frame: 32 weeks ]Percent of available funds earned as a composite measure.
- Retention [ Time Frame: 32 weeks ]Monthly rates of retention in the program.
- Drug Use Clinical Effectiveness [ Time Frame: 32 weeks ]Measured by DynamiCare saliva drug test results and weekly self-report.
- Cost-effectiveness [ Time Frame: 12 months ]Vermont Medicaid healthcare utilization claims costs vs. prior 12 months.
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
|Contact: David R Gastfriend, M.D.||firstname.lastname@example.org|
|United States, Vermont|
|Burlington, Vermont, United States, 05401|
|Contact: Care Advisor 802-489-7272|
|Principal Investigator:||Eric E Gastfriend, MBA||DynamiCare Health, Inc.|