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

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ClinicalTrials.gov Identifier: NCT03987581
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Alcohol Drinking Veterans Behavioral: Cognitive Behavioral Therapy (CBT) Behavioral: Mobile Contingency Management (mCM) Behavioral: Long-term incentive Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cost Effectiveness of Combined Contingency Management and Cognitive Behavioral Therapy for Alcohol Use Disorder
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: 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.
Behavioral: Cognitive Behavioral Therapy (CBT)
Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use).
Other Name: CBT

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 spins from a virtual prize wheel that contains 100 different values.
Other Names:
  • mCM
  • CM

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
Other Name: Incentive

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

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 spins from a virtual prize wheel that contains 100 different values.
Other Names:
  • mCM
  • CM

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

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
Other Name: Incentive

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




Primary Outcome Measures :
  1. Average number of heavy drinking days [ Time Frame: 6-month post quit visit ]
    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 :
  1. Average number of heavy drinking days [ Time Frame: 12-month post quit visit ]
    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.

  2. Average number of binge drinking days [ Time Frame: 6-month post quit visit ]
    Participants will self-report the number of binge drinking (heavy drinking within a 2-hour period) days in the past thirty days.

  3. Average number of binge drinking days [ Time Frame: 12-month post quit visit ]
    Participants will self-report the number of binge drinking (heavy drinking within a 2-hour period) days in the past thirty days.

  4. Average number of drinking days [ Time Frame: 6-month post quit visit ]
    Participants will self-report the number of drinking days in the past thirty days.

  5. Average number of drinking days [ Time Frame: 12-month post quit visit ]
    Participants will self-report the number of drinking days in the past thirty days.

  6. Average number of drinks per drinking day [ Time Frame: 6-month post quit visit ]
    Participants will self-report the number of drinks on drinking days in the past 30 days.

  7. Average number of drinks per drinking day [ Time Frame: 12-month post quit visit ]
    Participants will self-report the number of drinks on drinking days in the past 30 days.

  8. Self-reported abstinence [ Time Frame: 6-month post quit visit ]
    Participants will self-report whether or not consumed any alcohol in the past 30 days.

  9. Self-reported abstinence [ Time Frame: 12-month post quit visit ]
    Participants will self-report whether or not consumed any alcohol in the past 30 days.

  10. Bioverification of low-risk drinking [ Time Frame: Post-treatment, approximately 14 weeks ]
    Participants will provide a fingerstick blood sample. Phosphatidylethanol (PEth) testing will provide any evidence of excessive alcohol use in previous 4 weeks.

  11. Bioverification of low-risk drinking [ Time Frame: 6-month post quit visit ]
    Participants will provide a fingerstick blood sample. Phosphatidylethanol (PEth) testing will provide any evidence of excessive alcohol use in previous 4 weeks.

  12. Bioverification of low-risk drinking [ Time Frame: 12-month post quit visit ]
    Participants will provide a fingerstick blood sample. Phosphatidylethanol (PEth) testing will provide any evidence of excessive alcohol use in previous 4 weeks.

  13. Treatment utilization [ Time Frame: 6-month post quit visit ]
    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.

  14. Treatment utilization [ Time Frame: 12-month post quit visit ]
    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.

  15. Health care related quality of life [ Time Frame: 12-month post quit visit ]
    Health care related quality of life will be measured by the EuroQol.

  16. CBT treatment engagement [ Time Frame: Post-treatment, approximately 14 weeks ]
    The number of cognitive behavioral therapy treatment sessions completed by each participant will be measured to determine treatment engagement

  17. Incremental Cost-Effectiveness Ratio [ Time Frame: 12-month post quit visit ]
    Measure of cost-effectiveness; costs as the numerator and effectiveness as measured by quality-adjusted life years (QALY) as the denominator



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987581


Contacts
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Contact: Eric A Dedert, PhD 919-286-0411 ext 134055 ead16@duke.edu
Contact: Angela C Kirby, MS 919-286-0411 ext 175526 angela.kirby@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27706
Sponsors and Collaborators
Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03987581     History of Changes
Other Study ID Numbers: PRO00101744
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs