Clinical trial NCT03987581: Cost Effectiveness of Combined Contingency Management and Cognitive Behavioral Therapy for Alcohol Use Disorder
Official title: Cost Effectiveness of Combined Contingency Management and Cognitive Behavioral Therapy for Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Veterans
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Average number of heavy drinking days
timeFrame: 6-month post quit visit
Secondary outcomes:
measure: Average number of heavy drinking days
timeFrame: 12-month post quit visit
measure: Average number of binge drinking days
timeFrame: 6-month post quit visit
measure: Average number of binge drinking days
timeFrame: 12-month post quit visit
measure: Average number of drinking days
timeFrame: 6-month post quit visit
measure: Average number of drinking days
timeFrame: 12-month post quit visit
measure: Average number of drinks per drinking day
timeFrame: 6-month post quit visit
measure: Average number of drinks per drinking day
timeFrame: 12-month post quit visit
measure: Self-reported abstinence
timeFrame: 6-month post quit visit
measure: Self-reported abstinence
timeFrame: 12-month post quit visit
measure: Bioverification of low-risk drinking
timeFrame: Post-treatment, approximately 14 weeks
measure: Bioverification of low-risk drinking
timeFrame: 6-month post quit visit
measure: Bioverification of low-risk drinking
timeFrame: 12-month post quit visit
measure: Treatment utilization
timeFrame: 6-month post quit visit
measure: Treatment utilization
timeFrame: 12-month post quit visit
measure: Health care related quality of life
timeFrame: 12-month post quit visit
measure: CBT treatment engagement
timeFrame: Post-treatment, approximately 14 weeks
measure: Incremental Cost-Effectiveness Ratio
timeFrame: 12-month post quit visit
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References: