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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alcohol Drinking; Veterans
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Mobile Contingency Management (mCM); Behavioral: Long-term incentive

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27706
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT + mCM + incentive; Participants in this arm will receive 12 sessions of cognitive behavioral treatment, mobile contingency management for alcohol abstinence, and a monetary incentive for 30-day abstinence at the 6-month follow-up.	Behavioral: Cognitive Behavioral Therapy (CBT); Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use).; Other Names: CBT; Behavioral: Mobile Contingency Management (mCM); Abstinence (measured by breath alcohol) will be intermittently reinforced. For each breath alcohol concentration reading that tests negative, a participant will earn a virtual scratch-off lottery ticket that contains 100 different values.; Other Names: mCM; CM; Behavioral: Long-term incentive; This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date; Other Names: Incentive
Experimental: CBT + mCM + no incentive; Participants in this arm will receive 12 sessions of cognitive behavioral treatment and mobile contingency management for alcohol abstinence. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up.	Behavioral: Cognitive Behavioral Therapy (CBT); Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use).; Other Names: CBT; Behavioral: Mobile Contingency Management (mCM); Abstinence (measured by breath alcohol) will be intermittently reinforced. For each breath alcohol concentration reading that tests negative, a participant will earn a virtual scratch-off lottery ticket that contains 100 different values.; Other Names: mCM; CM
Experimental: CBT alone + incentive; Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period.	Behavioral: Cognitive Behavioral Therapy (CBT); Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use).; Other Names: CBT; Behavioral: Long-term incentive; This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date; Other Names: Incentive
Active Comparator: CBT alone + no incentive; Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period.	Behavioral: Cognitive Behavioral Therapy (CBT); Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use).; Other Names: CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average number of heavy drinking days	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.	6-month post quit visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average number of heavy drinking days	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.	12-month post quit visit
Average number of binge drinking days	Participants will self-report the number of binge drinking (heavy drinking within a 2-hour period) days in the past thirty days.	6-month post quit visit
Average number of binge drinking days	Participants will self-report the number of binge drinking (heavy drinking within a 2-hour period) days in the past thirty days.	12-month post quit visit
Average number of drinking days	Participants will self-report the number of drinking days in the past thirty days.	6-month post quit visit
Average number of drinking days	Participants will self-report the number of drinking days in the past thirty days.	12-month post quit visit
Average number of drinks per drinking day	Participants will self-report the number of drinks on drinking days in the past 30 days.	6-month post quit visit
Average number of drinks per drinking day	Participants will self-report the number of drinks on drinking days in the past 30 days.	12-month post quit visit
Self-reported abstinence	Participants will self-report whether or not consumed any alcohol in the past 30 days.	6-month post quit visit
Self-reported abstinence	Participants will self-report whether or not consumed any alcohol in the past 30 days.	12-month post quit visit
Bioverification of low-risk drinking	Participants will provide a fingerstick blood sample. Phosphatidylethanol (PEth) testing will provide any evidence of excessive alcohol use in previous 4 weeks.	Post-treatment, approximately 14 weeks
Bioverification of low-risk drinking	Participants will provide a fingerstick blood sample. Phosphatidylethanol (PEth) testing will provide any evidence of excessive alcohol use in previous 4 weeks.	6-month post quit visit
Bioverification of low-risk drinking	Participants will provide a fingerstick blood sample. Phosphatidylethanol (PEth) testing will provide any evidence of excessive alcohol use in previous 4 weeks.	12-month post quit visit
Treatment utilization	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.	6-month post quit visit
Treatment utilization	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.	12-month post quit visit
Health care related quality of life	Health care related quality of life will be measured by the EuroQol.	12-month post quit visit
CBT treatment engagement	The number of cognitive behavioral therapy treatment sessions completed by each participant will be measured to determine treatment engagement	Post-treatment, approximately 14 weeks
Incremental Cost-Effectiveness Ratio	Measure of cost-effectiveness; costs as the numerator and effectiveness as measured by quality-adjusted life years (QALY) as the denominator	12-month post quit visit

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2019
• Primary Completion (Estimated): April 15, 2024
• Study Completion (Estimated): October 15, 2024

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 12, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism
• Other Study ID Numbers: PRO00101744

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No