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

NCT ID: NCT03987581

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-26
• Study Completion Date: 2024-11-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy (CBT)

Intervention Type: BEHAVIORAL

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

Mobile Contingency Management (mCM)

Intervention Type: 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.

Long-term incentive

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy (CBT)

Intervention Type: BEHAVIORAL

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

Mobile Contingency Management (mCM)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy (CBT)

Intervention Type: BEHAVIORAL

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

Long-term incentive

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy (CBT)

Intervention Type: BEHAVIORAL

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

Interventions

Cognitive Behavioral Therapy (CBT)

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

Intervention Type: 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.

Intervention Type: 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

Intervention Type: BEHAVIORAL

Other Intervention Names

CBT; mCM; CM; Incentive

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

PRO00101744

Identifier Type: -

Identifier Source: org_study_id