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

Alcohol Drinking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03987581
• Other study ID #: PRO00101744
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 26, 2019
• Est. completion date: October 15, 2024

Study information

• Verified date: May 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: October 15, 2024
• Est. primary completion date: April 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcoholism
• Veterans

Intervention

Behavioral:
• Cognitive Behavioral Therapy (CBT)
Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use).
• 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.
• 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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Average number of drinking days	Participants will self-report the number of drinking days in the past thirty days.	6-month post quit visit
Secondary	Average number of drinking days	Participants will self-report the number of drinking days in the past thirty days.	12-month post quit visit
Secondary	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
Secondary	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
Secondary	Self-reported abstinence	Participants will self-report whether or not consumed any alcohol in the past 30 days.	6-month post quit visit
Secondary	Self-reported abstinence	Participants will self-report whether or not consumed any alcohol in the past 30 days.	12-month post quit visit
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Health care related quality of life	Health care related quality of life will be measured by the EuroQol.	12-month post quit visit
Secondary	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
Secondary	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