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

Primary Purpose

Alcohol Drinking, Veterans

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy (CBT)
Mobile Contingency Management (mCM)
Long-term incentive
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Drinking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

CBT + mCM + incentive

CBT + mCM + no incentive

CBT alone + incentive

CBT alone + no incentive

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Average number of drinking days
Participants will self-report the number of drinking days in the past thirty days.
Average number of drinking days
Participants will self-report the number of drinking days in the past thirty days.
Average number of drinks per drinking day
Participants will self-report the number of drinks on drinking days in the past 30 days.
Average number of drinks per drinking day
Participants will self-report the number of drinks on drinking days in the past 30 days.
Self-reported abstinence
Participants will self-report whether or not consumed any alcohol in the past 30 days.
Self-reported abstinence
Participants will self-report whether or not consumed any alcohol in the past 30 days.
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.
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.
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.
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.
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.
Health care related quality of life
Health care related quality of life will be measured by the EuroQol.
CBT treatment engagement
The number of cognitive behavioral therapy treatment sessions completed by each participant will be measured to determine treatment engagement
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

Full Information

First Posted
June 11, 2019
Last Updated
April 13, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03987581
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 26, 2019 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Veterans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT + mCM + incentive
Arm Type
Experimental
Arm Description
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.
Arm Title
CBT + mCM + no incentive
Arm Type
Experimental
Arm Description
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.
Arm Title
CBT alone + incentive
Arm Type
Experimental
Arm Description
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.
Arm Title
CBT alone + no incentive
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Other Intervention Name(s)
CBT
Intervention Description
Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use).
Intervention Type
Behavioral
Intervention Name(s)
Mobile Contingency Management (mCM)
Other Intervention Name(s)
mCM, CM
Intervention Description
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
Intervention Name(s)
Long-term incentive
Other Intervention Name(s)
Incentive
Intervention Description
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
Primary Outcome Measure Information:
Title
Average number of heavy drinking days
Description
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.
Time Frame
6-month post quit visit
Secondary Outcome Measure Information:
Title
Average number of heavy drinking days
Description
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.
Time Frame
12-month post quit visit
Title
Average number of binge drinking days
Description
Participants will self-report the number of binge drinking (heavy drinking within a 2-hour period) days in the past thirty days.
Time Frame
6-month post quit visit
Title
Average number of binge drinking days
Description
Participants will self-report the number of binge drinking (heavy drinking within a 2-hour period) days in the past thirty days.
Time Frame
12-month post quit visit
Title
Average number of drinking days
Description
Participants will self-report the number of drinking days in the past thirty days.
Time Frame
6-month post quit visit
Title
Average number of drinking days
Description
Participants will self-report the number of drinking days in the past thirty days.
Time Frame
12-month post quit visit
Title
Average number of drinks per drinking day
Description
Participants will self-report the number of drinks on drinking days in the past 30 days.
Time Frame
6-month post quit visit
Title
Average number of drinks per drinking day
Description
Participants will self-report the number of drinks on drinking days in the past 30 days.
Time Frame
12-month post quit visit
Title
Self-reported abstinence
Description
Participants will self-report whether or not consumed any alcohol in the past 30 days.
Time Frame
6-month post quit visit
Title
Self-reported abstinence
Description
Participants will self-report whether or not consumed any alcohol in the past 30 days.
Time Frame
12-month post quit visit
Title
Bioverification of low-risk drinking
Description
Participants will provide a fingerstick blood sample. Phosphatidylethanol (PEth) testing will provide any evidence of excessive alcohol use in previous 4 weeks.
Time Frame
Post-treatment, approximately 14 weeks
Title
Bioverification of low-risk drinking
Description
Participants will provide a fingerstick blood sample. Phosphatidylethanol (PEth) testing will provide any evidence of excessive alcohol use in previous 4 weeks.
Time Frame
6-month post quit visit
Title
Bioverification of low-risk drinking
Description
Participants will provide a fingerstick blood sample. Phosphatidylethanol (PEth) testing will provide any evidence of excessive alcohol use in previous 4 weeks.
Time Frame
12-month post quit visit
Title
Treatment utilization
Description
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.
Time Frame
6-month post quit visit
Title
Treatment utilization
Description
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.
Time Frame
12-month post quit visit
Title
Health care related quality of life
Description
Health care related quality of life will be measured by the EuroQol.
Time Frame
12-month post quit visit
Title
CBT treatment engagement
Description
The number of cognitive behavioral therapy treatment sessions completed by each participant will be measured to determine treatment engagement
Time Frame
Post-treatment, approximately 14 weeks
Title
Incremental Cost-Effectiveness Ratio
Description
Measure of cost-effectiveness; costs as the numerator and effectiveness as measured by quality-adjusted life years (QALY) as the denominator
Time Frame
12-month post quit visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27706
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data.

Learn more about this trial

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

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