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

NCT03987581 | Completed Results

• 1 other identifier: PRO00101744
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking; Veterans

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Average Number of Heavy Drinking Days

  12-month post quit visit

• Average Number of Binge Drinking Days

  6-month post quit visit

• Average Number of Binge Drinking Days

  12-month post quit visit

• Average Number of Drinking Days

  6-month post quit visit

• Average Number of Drinking Days

  12-month post quit visit

Study Arms (4)

CBT + mCM + incentive

EXPERIMENTAL

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); Behavioral: Mobile Contingency Management (mCM); Behavioral: Long-term incentive

CBT + mCM + no incentive

EXPERIMENTAL

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); Behavioral: Mobile Contingency Management (mCM)

CBT alone + incentive

EXPERIMENTAL

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); Behavioral: Long-term incentive

CBT alone + no incentive

ACTIVE COMPARATOR

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)

Interventions

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use).

Also known as: CBT

CBT + mCM + incentive; CBT + mCM + no incentive; CBT alone + incentive; CBT alone + no incentive

Mobile Contingency Management (mCM) BEHAVIORAL

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.

Also known as: mCM, CM

CBT + mCM + incentive; CBT + mCM + no incentive

Long-term incentive BEHAVIORAL

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

Also known as: Incentive

CBT + mCM + incentive; CBT alone + incentive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27706, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Angela Kirby
• Organization: Duke University School of Medicine

angela.caison.kirby@gmail.com

9198247729

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 17, 2019
• Study Start: November 26, 2019
• Primary Completion: April 11, 2024
• Study Completion: November 18, 2024
• Last Updated: June 29, 2025
• Results First Posted: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)