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Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement: Feasibility

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ClinicalTrials.gov Identifier: NCT03507075
Recruitment Status : Completed
First Posted : April 24, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Mikhail Koffarnus, Virginia Polytechnic Institute and State University

Tracking Information
First Submitted Date  ICMJE April 7, 2018
First Posted Date  ICMJE April 24, 2018
Last Update Posted Date April 24, 2018
Actual Study Start Date  ICMJE November 15, 2014
Actual Primary Completion Date January 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2018)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement: Feasibility
Official Title  ICMJE Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement: Feasibility
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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Use Disorder
Intervention  ICMJE
  • Behavioral: Contingency management: Contingent incentives
    Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol.
  • Behavioral: Contingency management: Noncontingent incentives
    Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Contingency management: Contingent incentives
  • Sham Comparator: Noncontingent
    The Noncontingent group will receive payments each day they successfully provide samples independent of the alcohol content of those samples.
    Intervention: Behavioral: Contingency management: Noncontingent incentives
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2018)
69
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 5, 2017
Actual Primary Completion Date January 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03507075
Other Study ID Numbers  ICMJE R21AA022727( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Responsible Party Mikhail Koffarnus, Virginia Polytechnic Institute and State University
Study Sponsor  ICMJE Mikhail Koffarnus
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Virginia Polytechnic Institute and State University
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP