Clinical trial NCT04581499: Tech-Enabled CM for AUD at Scale
Official title: Applying Technology-Enabled Contingency Management for Alcohol Use Disorder at Scale
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: DynamiCare Health
Sponsor class: INDUSTRY
Collaborators: name: RAND
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-10-09
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random-controlled trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Alcohol Use
timeFrame: 32 weeks
Secondary outcomes:
measure: Engagement
timeFrame: 32 weeks
measure: Retention
timeFrame: 32 weeks
measure: Drug Use Clinical Effectiveness
timeFrame: 32 weeks
measure: Cost-effectiveness
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: DynamiCare Health
state: Massachusetts
Study officials:
affiliation: DynamiCare Health Inc.
name: Eric E Gastfriend, MBA
role: PRINCIPAL_INVESTIGATOR
References: