Cost Effectiveness of Combined Contingency Management and Cognitive Behavioral Therapy for Alcohol Use Disorder

Not Applicable

Completed

• Conditions: Alcohol Drinking; Veterans

• Registration Number: NCT03987581
• Lead Sponsor: Duke University

Brief Summary

Alcohol contributes to 88,000 deaths and costs an estimated $223 billion annually in the United States. Alcohol use disorder (AUD) is highly prevalent in veterans. The positive public health impact of reducing heavy drinking among veterans with AUD would prevent significant medical morbidity and mortality. Contingency management (CM) is an intensive behavioral therapy that provides incentives to individuals for reducing substance use. Monitoring alcohol abstinence usually requires daily monitoring. Because of this difficulty, CM approaches for treatment of AUD are not currently available to people with AUD. Our group has developed a mobile smart-phone application that allows patients to video themselves using an alcohol breath monitor and transmit the encrypted data to a secure server. This innovation has made the use of CM for outpatient AUD treatment feasible. The aim of the current study is to evaluate the effectiveness and cost effectiveness of CM as an add-on to cognitive behavioral therapy for AUD. The trial will also explore the potential usefulness of a long-term abstinence incentive ontreatment utilization and alcohol outcomes. Proposed is a trial in which 140 veterans with AUD will be randomized to receive either CM as an add-on to evidence-based CBT or CBT alone. Veterans will also be randomized to one of two long-term incentive conditions (i.e., receipt of a monetary incentive for abstinence/low-risk drinking at 6- months vs. no incentive). This project aims to advance AUD treatment by 1) testing the effectiveness of a mobile health approach that makes CM for AUD feasible, and 2) providing highly needed cost-effectiveness data on the use of behavioral incentives as an adjunct to CBT for the treatment of AUD. These aims are designed to address two significant barriers to the implementation of CM for AUD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-11
• Study First Submitted QC: 2019-06-12
• Study First Posted: 2019-06-17
• Study Start: 2019-11-26
• Primary Completion: 2024-04-11
• Study Completion: 2024-11-18
• Results First Submitted: 2025-03-21
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-11
• Last Update Submitted: 2025-06-11
• Results First Posted: 2025-06-29
• Last Update Posted: 2025-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

• are an enrolled veteran at the DVAHCS for primary care,
• have current AUD (meeting past month DSM-5 criteria), and
• are willing to make a quit attempt and/or reduce alcohol use to low risk levels.

Exclusion Criteria

• have fewer than 3 days of abstinence,
• have a history of clinically significant alcohol withdrawal, as indicated by a score of 10 or more on the Clinical Institute Withdrawal Assessment of Alcohol (CIWA), or
• are currently receiving professional behavioral treatment for AUD.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Average Number of Heavy Drinking Days	6-month post quit visit	At the 6-month follow-up visit, participants will self-report the number of heavy drinking (\> 5 drinks in day for men, \> 4 drinks in a day for women) days they have had in the past thirty days.

Secondary Outcome Measures

Name	Time	Method
Average Number of Drinks Per Drinking Day	12-month post quit visit	Participants will self-report the number of drinks on drinking days in the past 30 days.
CBT Treatment Engagement as Measured by the Number of Cognitive Behavioral Therapy Treatment Sessions Completed	Post-treatment, approximately 14 weeks	The number of cognitive behavioral therapy treatment sessions completed by each participant will be measured to determine treatment engagement
Incremental Cost-Effectiveness Ratio	12-month post quit visit	Measure of cost-effectiveness; costs as the numerator and effectiveness as measured by quality-adjusted life years (QALY) as the denominator
Average Number of Heavy Drinking Days	12-month post quit visit	At the 12-month follow-up visit, participants will self-report the number of heavy drinking (\> 5 drinks in day for men, \> 4 drinks in a day for women) days in the past thirty days.
Average Number of Binge Drinking Days	12-month post quit visit	Participants will self-report the number of binge drinking (heavy drinking within a 2-hour period) days in the past thirty days.
Average Number of Drinking Days	12-month post quit visit	Participants will self-report the number of drinking days in the past thirty days.
Number of Participants With Self-reported Abstinence	12-month post quit visit	Participants will self-report whether or not consumed any alcohol in the past 30 days.
Number of Participants With Bioverification of Low-risk Drinking	12-month post quit visit	Participants will provide a fingerstick blood sample. Phosphatidylethanol (PEth) testing will provide any evidence of excessive alcohol use in previous 4 weeks.
Treatment Utilization as Measured by Number of Treatment Visits	12-month post quit visit	Participants will provide self-report on use of adjunct treatments (e.g., Alcoholics Anonymous, group counseling) for alcohol use during the period between post-treatment and follow-ups. Where available, Department of Veterans Affairs administrative data will be used to determine enrollment or involvement in aftercare treatment.
Health Care Related Quality of Life	12-month post quit visit	Health care related quality of life will be measured by the EuroQol.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States