Alcohol DrinkingNCT03987581
Cost Effectiveness of Combined Contingency Management and Cognitive Behavioral Therapy for Alcohol Use Disorder
A study testing Cognitive Behavioral Therapy (CBT), Mobile Contingency Management (mCM) and Long-term incentive in people with Alcohol Drinking and Veterans, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Drinking, Veterans
- What is being tested?
- Cognitive Behavioral Therapy (CBT), Mobile Contingency Management (mCM) and Long-term incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2019to 18 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27706
About this study
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.
- Conditions
- Alcohol Drinking, Veterans
- Being tested
- Cognitive Behavioral Therapy (CBT), Mobile Contingency Management (mCM), Long-term incentive
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
Also called CBT
Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use).
Mobile Contingency Management (mCM)Behavioural
Also called mCM, CM
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 incentiveBehavioural
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| CBT + mCM + incentive | Experimental | 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. Receives: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Mobile Contingency Management (mCM); Behavioral: Long-term incentive |
| CBT + mCM + no incentive | Experimental | 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. Receives: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Mobile Contingency Management (mCM) |
| CBT alone + incentive | Experimental | 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. Receives: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Long-term incentive |
| CBT alone + no incentive | Active comparator | 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. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-month post quit visit
Secondary outcomes (16)
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.
Measured: 12-month post quit visit
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.
Measured: 6-month post quit visit
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.
Measured: 12-month post quit visit
Average Number of Drinking Days
Participants will self-report the number of drinking days in the past thirty days.
Measured: 6-month post quit visit
Average Number of Drinking Days
Participants will self-report the number of drinking days in the past thirty days.
Measured: 12-month post quit visit
Average Number of Drinks Per Drinking Day
Participants will self-report the number of drinks on drinking days in the past 30 days.
Measured: 6-month post quit visit
Average Number of Drinks Per Drinking Day
Participants will self-report the number of drinks on drinking days in the past 30 days.
Measured: 12-month post quit visit
Number of Participants With Self-reported Abstinence
Participants will self-report whether or not consumed any alcohol in the past 30 days.
Measured: 6-month post quit visit
Number of Participants With Self-reported Abstinence
Participants will self-report whether or not consumed any alcohol in the past 30 days.
Measured: 12-month post quit visit
Number of Participants With 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.
Measured: 6-month post quit visit
Number of Participants With 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.
Measured: 12-month post quit visit
Treatment Utilization as Measured by Number of Treatment Visits
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.
Measured: 6-month post quit visit
Treatment Utilization as Measured by Number of Treatment Visits
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.
Measured: 12-month post quit visit
Health Care Related Quality of Life as Measured by the EuroQol (EQ-5D)
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.
Measured: 12-month post quit visit
CBT Treatment Engagement as Measured by the Number of Cognitive Behavioral Therapy Treatment Sessions Completed
The number of cognitive behavioral therapy treatment sessions completed by each participant will be measured to determine treatment engagement
Measured: Post-treatment, approximately 14 weeks
Incremental Cost-Effectiveness Ratio
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
Measured: 12-month post quit visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start26 Nov 2019
- Primary completion11 Apr 2024
- Study completion18 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987581
- Sponsor's protocol ID
- PRO00101744
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2019
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Effectiveness of Combined Contingency Management and Cognitive Behavioral Therapy for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT03987581
- Acronym / sponsor ID
- PRO00101744
- Conditions
- Alcohol Drinking, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 17 Jun 2019 (actual)
- Results
- Posted 29 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CBT + mCM + incentive | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT), Behavioral: Mobile Contingency Management (mCM), Behavioral: Long-term incentiveParticipants 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. |
| CBT + mCM + no incentive | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT), Behavioral: Mobile Contingency Management (mCM)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. |
| CBT alone + incentive | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT), Behavioral: Long-term incentiveParticipants 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. |
| CBT alone + no incentive | Active comparator | Behavioral: Cognitive Behavioral Therapy (CBT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy (CBT)Also: CBTTwelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). | Behavioural | CBT + mCM + incentive, CBT + mCM + no incentive, CBT alone + incentive, CBT alone + no incentive |
| Mobile Contingency Management (mCM)Also: mCM, CMAbstinence (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. | Behavioural | CBT + mCM + incentive, CBT + mCM + no incentive |
| Long-term incentiveAlso: IncentiveThis 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 | Behavioural | CBT + mCM + incentive, CBT alone + incentive |
Primary outcome
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.
16 secondary outcomes
Average Number of Heavy Drinking Days
Time frame: 12-month post quit visit
Average Number of Binge Drinking Days
Time frame: 6-month post quit visit
Average Number of Binge Drinking Days
Time frame: 12-month post quit visit
Average Number of Drinking Days
Time frame: 6-month post quit visit
Average Number of Drinking Days
Time frame: 12-month post quit visit
Average Number of Drinks Per Drinking Day
Time frame: 6-month post quit visit
Average Number of Drinks Per Drinking Day
Time frame: 12-month post quit visit
Number of Participants With Self-reported Abstinence
Time frame: 6-month post quit visit
Number of Participants With Self-reported Abstinence
Time frame: 12-month post quit visit
Number of Participants With Bioverification of Low-risk Drinking
Time frame: 6-month post quit visit
Number of Participants With Bioverification of Low-risk Drinking
Time frame: 12-month post quit visit
Treatment Utilization as Measured by Number of Treatment Visits
Time frame: 6-month post quit visit
Treatment Utilization as Measured by Number of Treatment Visits
Time frame: 12-month post quit visit
Health Care Related Quality of Life as Measured by the EuroQol (EQ-5D)
Time frame: 12-month post quit visit
CBT Treatment Engagement as Measured by the Number of Cognitive Behavioral Therapy Treatment Sessions Completed
Time frame: Post-treatment, approximately 14 weeks
Incremental Cost-Effectiveness Ratio
Time frame: 12-month post quit visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT), Mobile Contingency Management (mCM) and Long-term incentive in people with Alcohol Drinking and Veterans, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Number of Heavy Drinking Days (time frame: 6-month post quit visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.