Alcohol Use DisorderPhase 1/2NCT03507075
Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement: Feasibility
A Phase 1/2 study testing Contingency management: Contingent incentives and Contingency management: Noncontingent incentives in people with Alcohol Use Disorder, run by Mikhail Koffarnus.
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: Contingent incentives and Contingency management: Noncontingent incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2014to 5 Jan 2017
- Phase
- Phase 1/2
- 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
- At least 18 years old
- Provide written informed consent
- Meet Diagnostic and Statistical Manual criteria for alcohol use disorder
- Express a desire to cut down or quit drinking
Who cannot join
- Pregnant or lactating
- Meet Diagnostic and Statistical Manual criteria for other substance use disorder (except caffeine or nicotine)
- Score 23 or greater on the Alcohol Withdrawal Symptom Checklist
- Have immediate plans to move out of the area
About this study
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 feasibility study is to determine if using technological advancements to remotely, accurately, and securely monitor alcohol use with a newly developed breathalyzer is an effective treatment that is acceptable to participants. If validated, 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: Contingent incentives, Contingency management: Noncontingent incentives
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency management: Contingent incentivesBehavioural
Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol.
Contingency management: Noncontingent incentivesBehavioural
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 |
|---|---|---|
| Contingent | Active comparator | The Contingent group 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. Receives: Behavioral: Contingency management: Contingent incentives |
| Noncontingent | Sham comparator | The Noncontingent group will receive payments each day they successfully provide samples independent of the alcohol content of those samples. Receives: Behavioral: Contingency management: Noncontingent incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent days abstinent from alcohol during intervention
Three breathalyzer assessments will be collected per day during the treatment period. This outcome measure will consist of the percent days when all three breathalyzers were on time and negative for alcohol.
Measured: Percent days abstinent is the aggregate measure throughout the 21-day intervention period
Treatment acceptability
Participant ratings of treatment acceptability will be collected during assessment sessions
Measured: Baseline, one day after treatment end, and at a one-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start15 Nov 2014
- Primary completion5 Jan 2017
- Study completion5 Jan 2017
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mikhail Koffarnus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mikhail Koffarnus, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507075
- Sponsor's protocol ID
- R21AA022727
- Status last verified
- Apr 2018
- First submitted
- 7 Apr 2018
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement: Feasibility
- ClinicalTrials.gov ID
- NCT03507075
- Acronym / sponsor ID
- R21AA022727
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Mikhail KoffarnusUniversity, hospital or other
- Study start
- 15 Nov 2014 (actual)
- Primary completion
- 5 Jan 2017 (actual)
- Study completion
- 5 Jan 2017 (actual)
- First posted
- 24 Apr 2018 (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 feasibility study is to determine if using technological advancements to remotely, accurately, and securely monitor alcohol use with a newly developed breathalyzer is an effective treatment that is acceptable to participants. If validated, 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingent | Active comparator | Behavioral: Contingency management: Contingent incentivesThe Contingent group 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. |
| Noncontingent | Sham comparator | Behavioral: Contingency management: Noncontingent incentivesThe Noncontingent group will receive payments each day they successfully provide samples independent of the alcohol content of those samples. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years old
- Provide written informed consent
- Meet Diagnostic and Statistical Manual criteria for alcohol use disorder
- Express a desire to cut down or quit drinking
Key exclusion criteria (4 listed)
- Pregnant or lactating
- Meet Diagnostic and Statistical Manual criteria for other substance use disorder (except caffeine or nicotine)
- Score 23 or greater on the Alcohol Withdrawal Symptom Checklist
- Have immediate plans to move out of the area
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 management: Contingent incentivesMonetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol. | Behavioural | Contingent |
| Contingency management: Noncontingent incentivesMonetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use. | Behavioural | Noncontingent |
Primary outcome
Percent days abstinent from alcohol during intervention
Time frame: Percent days abstinent is the aggregate measure throughout the 21-day intervention period
Three breathalyzer assessments will be collected per day during the treatment period. This outcome measure will consist of the percent days when all three breathalyzers were on time and negative for alcohol.
Treatment acceptability
Time frame: Baseline, one day after treatment end, and at a one-month follow-up
Participant ratings of treatment acceptability 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 24 Apr 2018.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Contingency management: Contingent incentives and Contingency management: Noncontingent incentives in people with Alcohol Use Disorder, run by Mikhail Koffarnus.
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 4 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 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percent days abstinent from alcohol during intervention (time frame: Percent days abstinent is the aggregate measure throughout the 21-day intervention period). 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 24 Apr 2018.