NCT04182022

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 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 2, 2019

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

2.6 years

First QC Date

November 26, 2019

Last Update Submit

June 2, 2023

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 incentivesBEHAVIORAL

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

Contingent
Contingency management: Noncontingent incentivesBEHAVIORAL

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

Noncontingent

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • Be willing to pay a $75 deposit toward their incentive fund

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 34110885DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2019

First Posted

December 2, 2019

Study Start

December 1, 2016

Primary Completion

July 10, 2019

Study Completion

July 10, 2019

Last Updated

June 7, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
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