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Completed

NCT Number: NCT03987581

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

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.

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Key information

Conditions

Alcohol Drinking Behavior Drinking Behavior Veterans

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27706, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Behavioral Therapy (CBT)

Behavioral

Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use).

Other names: CBT

mobile contingency management (mCM)

Behavioral

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.

Other names: mCM, CM

Long-term incentive

Behavioral

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 names: Incentive

Primary outcomes

  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 outcomes

  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. Number of Participants With 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. Number of Participants With 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. Number of Participants With 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.

  11. Number of Participants With 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.

  12. Treatment Utilization as Measured by Number of Treatment Visits

    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.

  13. Treatment Utilization as Measured by Number of Treatment Visits

    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.

  14. Health Care Related Quality of Life as Measured by the EuroQol (EQ-5D)

    Time frame: 12-month post quit visit

    EuroQol (EQ-5D) scoring converts patient-reported health states across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) into a single numerical index (utility value) anchored at 1 (full health) and 0 (dead), with values below 0 possible for states "worse than dead". The EQ-5D utility value typically ranges from ≤ 0 (a state considered "worse than dead") to 1 (perfect health). The study team applied the Pickard et al., 2019 United States value set, which sets the value range from a theoretical minimum of -0.573 to a maximum of 1. This scale is used in health economics to calculate Quality-Adjusted Life-Years (QALYs), where 0 represents being deceased.

  15. CBT Treatment Engagement as Measured by the Number of Cognitive Behavioral Therapy Treatment Sessions Completed

    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

  16. Incremental Cost-Effectiveness Ratio

    Time frame: 12-month post quit visit

    Measure of cost-effectiveness; computed by dividing the difference in costs between two interventions by the difference in their health outcomes. The formula is (Cost of A - Cost of B) / (Outcome of A - Outcome of B). The result shows the additional cost for each additional unit of health gain from the more effective intervention compared to the less effective one, such as the cost per Quality-Adjusted Life Year (QALY) gained

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jun 17, 2019
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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