Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 2

• ClinicalTrials.gov Identifier: NCT03942770
• Recruitment Status: Enrolling by invitation
• First Posted: May 8, 2019
• Last Update Posted: April 6, 2021
• Sponsor: Mikhail N Koffarnus
• Information provided by (Responsible Party): Mikhail N Koffarnus, University of Kentucky

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. As our feasibility study demonstrates, remote breathalyzer monitoring drastically improves the practicality of delivering an alcohol contingency management intervention. In Experiment 2, we will test whether the addition of remote abstinence incentives to treatment as usual improves outpatient treatment outcomes and prevents relapse following inpatient detoxification at a regional hospital system. We will also assess whether readmission rates are reduced using a newly developed smartphone app and breathalyzer.

Condition or disease	Intervention/treatment	Phase
Alcohol Use Disorder	Behavioral: Contingency Management; Behavioral: Contingency management	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 230 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement With an Underserved Population
• Actual Study Start Date: July 15, 2019
• Estimated Primary Completion Date: September 2023
• Estimated Study Completion Date: November 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Active Comparator: Group A (Intensive incentives); Group A will have the opportunity to earn payments based on the results of their breathalyzer screens. Participants will receive a compliance incentive per submitted sample regardless of the results, but will also have the opportunity to earn more incentives for providing negative results. For the first 3 weeks, these additional incentives will scale based on the number of consecutive days of sustained negative samples. For the remaining weeks incentives will be based on a randomized "prize" drawing.	Behavioral: Contingency Management; Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol.; Other Name: Contingent incentives
Active Comparator: Active Comparator: Group B (Prize-based incentives); Group B will have the opportunity to earn payments based on the results of their breathalyzer screens. Participants will receive a compliance incentive per submitted sample regardless of the results, but will only have the opportunity to earn more incentives based on a randomized "prize" drawing if they submit a negative sample.	Behavioral: Contingency Management; Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol.; Other Name: Contingent incentives
Sham Comparator: Sham Comparator: Group C (Intensive incentives); Group C serves as a direct control group to Group A and will follow the same incentive procedures, however participants will receive incentives regardless of the results of their samples.	Behavioral: Contingency management; Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.; Other Name: Noncontingent incentives
Sham Comparator: Sham Comparator: Group D (Price-based incentives); Group D serves as a direct control group to Group B and will follow the same incentive procedures, however participants will receive incentives regardless of the results of their samples.	Behavioral: Contingency management; Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.; Other Name: Noncontingent incentives
No Intervention: No Intervention: Group E (no incentives); Group E will have no monitoring intervention, they will only complete assessment sessions.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. Treatment acceptability [ Time Frame: A total of 12 assessment sessions spanning over a 66 week period ]
   Participant ratings of treatment acceptability on a customized Treatment Acceptability questionnaire will be collected during assessment sessions. Each question will be scored from 1 (low) to 4 (high) and will assess distinct components of the treatment. Questions will be interpreted and scored individually and not be summed together.
3. Time to relapse [ Time Frame: A total of 12 assessment sessions spanning over a 66 week period ]
   For this outcome, we will conduct survival analyses to compare relapse across study groups.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Recently completed or currently completing an alcohol detoxification program through the Carilion Clinic system.
• Abstinent from alcohol at the time of consent.

Exclusion Criteria:

• Meet Diagnostic and Statistical Manual (DSM) 5 substance use disorder criteria for any other drug of abuse (excluding nicotine and caffeine)

Contacts and Locations

Locations

United States, Virginia

Virginia Tech Carilion

Roanoke, Virginia, United States, 24016

Sponsors and Collaborators

Mikhail N Koffarnus

More Information

• Responsible Party: Mikhail N Koffarnus, Associate Professor, University of Kentucky
• ClinicalTrials.gov Identifier: NCT03942770
• Other Study ID Numbers: 19-324
• First Posted: May 8, 2019
• Last Update Posted: April 6, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Alcoholism; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders