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OpenTrials
Completed

NCT Number: NCT03507075

Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement: Feasibility

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contingency management: Contingent incentives

Behavioral

Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol.

Contingency management: Noncontingent incentives

Behavioral

Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mikhail Koffarnus

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 24, 2018
Registry last updated
Apr 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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