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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

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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Behavioral: Contingency management: Contingent incentives Behavioral: Contingency management: Noncontingent incentives Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement: Feasibility
Actual Study Start Date : November 15, 2014
Actual Primary Completion Date : January 5, 2017
Actual Study Completion Date : January 5, 2017

Resource links provided by the National Library of Medicine


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.
Behavioral: Contingency management: Contingent incentives
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.
Behavioral: Contingency management: Noncontingent incentives
Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.




Primary Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

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

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
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Responsible Party: Mikhail Koffarnus, Research Assistant Professor, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier: NCT03507075    
Other Study ID Numbers: R21AA022727 ( U.S. NIH Grant/Contract )
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
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)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders