Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement: Feasibility

NCT03507075 | Completed Phase 1

• 1 other identifier: R21AA022727
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Contingent

ACTIVE COMPARATOR

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

Noncontingent

SHAM COMPARATOR

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

Interventions

Contingency management: Contingent incentives BEHAVIORAL

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

Contingent

Contingency management: Noncontingent incentives BEHAVIORAL

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

Noncontingent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mikhail Koffarnus: lead

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: April 7, 2018
• First Posted: April 24, 2018
• Study Start: November 15, 2014
• Primary Completion: January 5, 2017
• Study Completion: January 5, 2017
• Last Updated: April 24, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF