Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement: Feasibility

Alcohol Use Disorder Clinical Trial

Official title:

Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement: Feasibility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03507075
• Other study ID #: R21AA022727
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 7, 2018
• Last updated: April 23, 2018
• Start date: November 15, 2014
• Est. completion date: January 5, 2017

Study information

• Verified date: April 2018
• Source: Virginia Polytechnic Institute and State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: January 5, 2017
• Est. primary completion date: January 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mikhail Koffarnus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent days abstinent from alcohol during intervention	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.	Percent days abstinent is the aggregate measure throughout the 21-day intervention period
Primary	Treatment acceptability	Participant ratings of treatment acceptability will be collected during assessment sessions	Baseline, one day after treatment end, and at a one-month follow-up