Financially Sustainable Remote Treatment for Alcohol Abuse: Feasibility
Primary Purpose
Alcohol Use Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Contingency management: Contingent incentives
Contingency management: Noncontingent incentives
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder
Eligibility Criteria
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
- Be willing to pay a $75 deposit toward their incentive fund
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Contingent
Noncontingent
Arm Description
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.
The Noncontingent group will receive payments each day they successfully provide samples independent of the alcohol content of those samples.
Outcomes
Primary Outcome Measures
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.
Treatment acceptability
Participant ratings of treatment acceptability will be collected during assessment sessions
Secondary Outcome Measures
Full Information
NCT ID
NCT04182022
First Posted
November 26, 2019
Last Updated
June 2, 2023
Sponsor
Virginia Polytechnic Institute and State University
1. Study Identification
Unique Protocol Identification Number
NCT04182022
Brief Title
Financially Sustainable Remote Treatment for Alcohol Abuse: Feasibility
Official Title
Financially Sustainable Remote Treatment for Alcohol Abuse: Feasibility
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
July 10, 2019 (Actual)
Study Completion Date
July 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Polytechnic Institute and State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. The goal of this feasibility study is to use a breathalyzer and cost-controlling deposit contracts to facilitate a contingency-management intervention to reduce alcohol use that requires no in-person contact between the participants and the study staff during the intervention phase.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Contingent
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Noncontingent
Arm Type
Sham Comparator
Arm Description
The Noncontingent group will receive payments each day they successfully provide samples independent of the alcohol content of those samples.
Intervention Type
Behavioral
Intervention Name(s)
Contingency management: Contingent incentives
Intervention Description
Monetary incentives are delivered to participants contingent upon on- time breathalyzer submissions and verified abstinence from alcohol.
Intervention Type
Behavioral
Intervention Name(s)
Contingency management: Noncontingent incentives
Intervention Description
Monetary incentives are delivered to participants contingent upon on- time breathalyzer submissions only with no contingency on alcohol use.
Primary Outcome Measure Information:
Title
Percent days abstinent from alcohol during intervention
Description
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.
Time Frame
Percent days abstinent is the aggregate measure throughout the 21-day intervention period
Title
Treatment acceptability
Description
Participant ratings of treatment acceptability will be collected during assessment sessions
Time Frame
Baseline, one day after treatment end, and at a one-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Be willing to pay a $75 deposit toward their incentive fund
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
34110885
Citation
Koffarnus MN, Kablinger AS, Kaplan BA, Crill EM. Remotely administered incentive-based treatment for alcohol use disorder with participant-funded incentives is effective but less accessible to low-income participants. Exp Clin Psychopharmacol. 2021 Oct;29(5):555-565. doi: 10.1037/pha0000503. Epub 2021 Jun 10.
Results Reference
derived
Learn more about this trial
Financially Sustainable Remote Treatment for Alcohol Abuse: Feasibility
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