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N/A N=140 Randomized Treatment

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

Alcohol Drinking · Veterans

Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Average Number of Heavy Drinking Days — 15.1; 15.9; 13.2; 11.3 days

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Cognitive Behavioral Therapy (CBT) (Behavioral); Mobile Contingency Management (mCM) (Behavioral); Long-term incentive (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Duke University
Primary completion
Apr 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Average Number of Heavy Drinking Days
2.8; 1.2; 2.4; 4.5
SECONDARY
Average Number of Heavy Drinking Days
2.8; 1.2; 2.4; 4.5
SECONDARY
Average Number of Binge Drinking Days
0.5; 0.7; 0.8; 4.0
SECONDARY
Average Number of Binge Drinking Days
0.5; 0.7; 0.8; 4.0
SECONDARY
Average Number of Drinking Days
10.5; 8.0; 8.1; 12.3
SECONDARY
Average Number of Drinking Days
10.5; 8.0; 8.1; 12.3
SECONDARY
Average Number of Drinks Per Drinking Day
3.5; 2.3; 3.2; 2.8
SECONDARY
Average Number of Drinks Per Drinking Day
3.5; 2.3; 3.2; 2.8
SECONDARY
Number of Participants With Self-reported Abstinence
5; 8; 5; 3
SECONDARY
Number of Participants With Self-reported Abstinence
5; 8; 5; 3
SECONDARY
Number of Participants With Bioverification of Low-risk Drinking
4; 13; 9; 6
SECONDARY
Number of Participants With Bioverification of Low-risk Drinking
4; 13; 9; 6
SECONDARY
Treatment Utilization as Measured by Number of Treatment Visits
0.6; 8.2; 2.9; 0.3
SECONDARY
Treatment Utilization as Measured by Number of Treatment Visits
0.6; 8.2; 2.9; 0.3
SECONDARY
Health Care Related Quality of Life
SECONDARY
CBT Treatment Engagement as Measured by the Number of Cognitive Behavioral Therapy Treatment Sessions Completed
10.4; 9.6; 9.1; 9.3
SECONDARY
Incremental Cost-Effectiveness Ratio

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03987581). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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