- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03507075
Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement: Feasibility
April 23, 2018 updated by: Mikhail Koffarnus
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 Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
69
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Contingent
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.
|
Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol.
|
Sham Comparator: Noncontingent
The Noncontingent group will receive payments each day they successfully provide samples independent of the alcohol content of those samples.
|
Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Percent days abstinent is the aggregate measure throughout the 21-day intervention period
|
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
|
Baseline, one day after treatment end, and at a one-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2014
Primary Completion (Actual)
January 5, 2017
Study Completion (Actual)
January 5, 2017
Study Registration Dates
First Submitted
April 7, 2018
First Submitted That Met QC Criteria
April 23, 2018
First Posted (Actual)
April 24, 2018
Study Record Updates
Last Update Posted (Actual)
April 24, 2018
Last Update Submitted That Met QC Criteria
April 23, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AA022727 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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