About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

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 December 11, 2019

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:Alcohol Use Disorder
  • Intervention/Treatment: Behavioral: Contingency Management
    Behavioral: Contingency management
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 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.
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.
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.
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.
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
Contacts
Locations

United States, Virginia
Virginia Tech Carilion
Roanoke

Sponsors and Collaborators

Mikhail N Koffarnus

More Information
  • Responsible Party: Mikhail N Koffarnus
  • ClinicalTrials.gov Identifier: NCT03942770 History of Changes
  • Other Study ID Numbers: 19-324
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: December 11, 2019
  • Last Verified: December 2019
  • 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