Financially Sustainable Remote Treatment for Alcohol Abuse: 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 use a breathalyzer and cost-controlling deposit contracts to facilitate a contingency-management intervention to reduce alcohol use that requires no in-person contact between the participants and the study staff during the intervention phase.

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Behavioral: Contingency management: Contingent incentives; Behavioral: Contingency management: Noncontingent incentives

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
• Be willing to pay a $75 deposit toward their incentive fund

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Virginia Polytechnic Institute and State University

Publications and helpful links

General Publications

• Koffarnus MN, Kablinger AS, Kaplan BA, Crill EM. Remotely administered incentive-based treatment for alcohol use disorder with participant-funded incentives is effective but less accessible to low-income participants. Exp Clin Psychopharmacol. 2021 Oct;29(5):555-565. doi: 10.1037/pha0000503. Epub 2021 Jun 10.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): July 10, 2019
• Study Completion (Actual): July 10, 2019

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: R21AA023605 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No