Alcohol Use DisorderNCT03883126
Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 1
A study testing Contingency management in people with Alcohol Use Disorder, run by Mikhail N Koffarnus at 3 sites in United States.
Trial summary
Directly reinforcing abstinence from alcohol with monetary incentives is an effective treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical measures of abstinence limit the dissemination of this treatment approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Contingency management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 211 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Jun 2020to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Meet Diagnostic and Statistical Manual (DSM)-5 criteria for alcohol use disorder
- Average 3 or more heavy drinking days (≥5 drinks in one occasion for men, ≥4 for women) per week for the past month on the Timeline Follow-back.
- Must endorse alcohol as their primary drug of use.
- Express a desire to abstain from drinking.
Who cannot join
- Are currently enrolled in an alcohol treatment program (not including attendance at Alcoholics Anonymous or similar community support meetings).
- Score 23 or greater on the Alcohol Withdrawal Symptom Checklist, a score indicating that medication would be likely required to manage alcohol detoxification.
- Pregnant women, lactating women, or women who are planning to become pregnant in the next 15 months.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Nationwide Online Enrollment from the Unversity of Kentucky
Lexington, Kentucky, 40504
University of Kentucky Turfland: In-person enrollment
Lexington, Kentucky, 40504
Carilion Clinic: In person-enrollment
Roanoke, Virginia, 24014
About this study
Official title: Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement With an Underserved Population
Directly reinforcing abstinence from alcohol with monetary incentives is an effective treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical measures of abstinence limit the dissemination of this treatment approach. The goal of this study is to use technological advancements to remotely, accurately, and securely monitor alcohol use with a newly developed smartphone app and breathalyzer. This treatment approach has the potential to facilitate the dissemination of an effective, evidence-based treatment for alcohol dependence to a broader population whose treatment needs are not currently being adequately met.
- Conditions
- Alcohol Use Disorder
- Being tested
- Contingency management
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency managementBehavioural
Also called Contingent incentives
Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol.
Contingency managementBehavioural
Also called Noncontingent incentives
Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A will receive nearly immediate monetary payments over the internet each day they remotely provide negative breathalyzer samples, but will not receive the payments if they provide positive samples or fail to provide samples in a timely manner for the first 3 weeks of the intervention. For the remaining 9 weeks they will continue to receive incentives for submitting negative samples. Receives: Behavioral: Contingency management |
| Group B | Active comparator | Group B will receive nearly immediate monetary payments over the internet each day they remotely provide negative breathalyzer samples, but will not receive the payments if they provide positive samples or fail to provide samples in a timely manner for the first 3 weeks of the intervention.For the remaining 9 weeks they will not be required to submit breathalyzer samples. Receives: Behavioral: Contingency management |
| Group C | Sham comparator | Group C will receive nearly immediate monetary payments over the internet each day they remotely provide breathalyzer samples regardless of the alcohol content, but will not receive the payments if they fail to provide samples in a timely manner for the first 3 weeks of the intervention. For the remaining 9 weeks they will continue to receive incentives for submitting on time samples regardless of alcohol content. Receives: Behavioral: Contingency management |
| Group D | Sham comparator | Group D will receive nearly immediate monetary payments over the internet each day they remotely provide breathalyzer samples regardless of the alcohol content, but will not receive the payments if they fail to provide samples in a timely manner for the first 3 weeks of the intervention. For the remaining 9 weeks they will not be required to submit breathalyzer samples. Receives: Behavioral: Contingency management |
| Group E | No intervention | Group E will have no intervention, they will only complete assessment sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern of abstinence from alcohol during intervention
Breathalyzer assessments will be collected during the treatment period. This outcome measure will consist of the percentage of days without alcohol use as detected by the breathalyzers.
Measured: up to 66 weeks
Treatment acceptability
Participant ratings of treatment acceptability on a customized questionnaire will be collected during assessment sessions
Measured: A total of 12 assessment sessions spanning over a 66 week period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start16 Jun 2020
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mikhail N Koffarnus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, Mikhail N Koffarnus, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883126
- Sponsor's protocol ID
- 54073
- Other IDs
- R01AA026605
- Status last verified
- Oct 2026
- First submitted
- 15 Mar 2019
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final research data for this project will be made as available as possible, while safeguarding the privacy of participants and protecting all confidential and proprietary data. Data will be available for use after the main findings from the final dataset have been accepted for publication. The data and associated documentation will only be made available to users under a Data Use Agreement that provides for 1) a commitment to using the data only for research purposes and not to identify any individual participant and 2) a commitment to destroying or returning the data after analyses are completed. To ensure compliance with HIPAA regulations, only a Limited Data Set will be available for use. The method of data release will be determined on a case-by-case basis depending upon the amount and type of data required.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement With an Underserved Population
- ClinicalTrials.gov ID
- NCT03883126
- Acronym / sponsor ID
- 54073
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Mikhail N KoffarnusUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Directly reinforcing abstinence from alcohol with monetary incentives is an effective treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical measures of abstinence limit the dissemination of this treatment approach. The goal of this study is to use technological advancements to remotely, accurately, and securely monitor alcohol use with a newly developed smartphone app and breathalyzer. This treatment approach has the potential to facilitate the dissemination of an effective, evidence-based treatment for alcohol dependence to a broader population whose treatment needs are not currently being adequately met.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Behavioral: Contingency managementGroup A will receive nearly immediate monetary payments over the internet each day they remotely provide negative breathalyzer samples, but will not receive the payments if they provide positive samples or fail to provide samples in a timely manner for the first 3 weeks of the intervention. For the remaining 9 weeks they will continue to receive incentives for submitting negative samples. |
| Group B | Active comparator | Behavioral: Contingency managementGroup B will receive nearly immediate monetary payments over the internet each day they remotely provide negative breathalyzer samples, but will not receive the payments if they provide positive samples or fail to provide samples in a timely manner for the first 3 weeks of the intervention.For the remaining 9 weeks they will not be required to submit breathalyzer samples. |
| Group C | Sham comparator | Behavioral: Contingency managementGroup C will receive nearly immediate monetary payments over the internet each day they remotely provide breathalyzer samples regardless of the alcohol content, but will not receive the payments if they fail to provide samples in a timely manner for the first 3 weeks of the intervention. For the remaining 9 weeks they will continue to receive incentives for submitting on time samples regardless of alcohol content. |
| Group D | Sham comparator | Behavioral: Contingency managementGroup D will receive nearly immediate monetary payments over the internet each day they remotely provide breathalyzer samples regardless of the alcohol content, but will not receive the payments if they fail to provide samples in a timely manner for the first 3 weeks of the intervention. For the remaining 9 weeks they will not be required to submit breathalyzer samples. |
| Group E | No intervention | –Group E will have no intervention, they will only complete assessment sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet Diagnostic and Statistical Manual (DSM)-5 criteria for alcohol use disorder
- Average 3 or more heavy drinking days (≥5 drinks in one occasion for men, ≥4 for women) per week for the past month on the Timeline Follow-back.
- Must endorse alcohol as their primary drug of use.
- Express a desire to abstain from drinking.
Key exclusion criteria (3 listed)
- Are currently enrolled in an alcohol treatment program (not including attendance at Alcoholics Anonymous or similar community support meetings).
- Score 23 or greater on the Alcohol Withdrawal Symptom Checklist, a score indicating that medication would be likely required to manage alcohol detoxification.
- Pregnant women, lactating women, or women who are planning to become pregnant in the next 15 months.
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 |
|---|---|---|
| Contingency managementAlso: Contingent incentivesMonetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol. | Behavioural | Group A, Group B |
| Contingency managementAlso: Noncontingent incentivesMonetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use. | Behavioural | Group C, Group D |
Primary outcome
Pattern of abstinence from alcohol during intervention
Time frame: up to 66 weeks
Breathalyzer assessments will be collected during the treatment period. This outcome measure will consist of the percentage of days without alcohol use as detected by the breathalyzers.
Treatment acceptability
Time frame: A total of 12 assessment sessions spanning over a 66 week period.
Participant ratings of treatment acceptability on a customized questionnaire will be collected during assessment sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Yes. Final research data for this project will be made as available as possible, while safeguarding the privacy of participants and protecting all confidential and proprietary data. Data will be available for use after the main findings from the final dataset have been accepted for publication. The data and associated documentation will only be made available to users under a Data Use Agreement that provides for 1) a commitment to using the data only for research purposes and not to identify any individual participant and 2) a commitment to destroying or returning the data after analyses are completed. To ensure compliance with HIPAA regulations, only a Limited Data Set will be available for use. The method of data release will be determined on a case-by-case basis depending upon the amount and type of data required.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency management in people with Alcohol Use Disorder, run by Mikhail N Koffarnus at 3 sites 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 4 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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pattern of abstinence from alcohol during intervention (time frame: up to 66 weeks). The study lists 2 primary outcomes in all. 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 9 Oct 2026.