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NCT03987581 · ClinicalTrials.gov registry record · NA
Cost Effectiveness of Combined Contingency Management and Cognitive Behavioral Therapy for Alcohol Use Disorder
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 151
- Enrollment target
NCT03987581: Completed NA study, sponsored by Duke University.
NCT03987581 is a NA study that has completed, run by Duke University. The registered enrollment target is 151 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03987581, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 151 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy (CBT)
- BEHAVIORAL Mobile Contingency Management (mCM)
- BEHAVIORAL Long-term incentive
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2019-11-26 |
| Est. Completion | 2024-11-18 |
| Phase | NA |
What the finished NCT03987581 record still lists
NCT03987581 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 3 interventions - of which Cognitive Behavioral Therapy (CBT) is the first listed.
NCT03987581 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03987581 about?
NCT03987581 is a clinical study titled "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 mor...
What is the current status of trial NCT03987581?
This trial is currently completed. It is a NA study. The enrollment target is 151 participants. The study started on 2019-11-26. Estimated completion is 2024-11-18.
What interventions are being tested in trial NCT03987581?
The interventions under investigation include: Cognitive Behavioral Therapy (CBT) (BEHAVIORAL), Mobile Contingency Management (mCM) (BEHAVIORAL), Long-term incentive (BEHAVIORAL).
Who is sponsoring clinical trial NCT03987581?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03987581's enrollment target sits among peer trials
151 661st of 2000 higher than 1,340 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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