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Purpose

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 study is to use technological advancements to remotely, accurately, and securely monitor alcohol use with a newly developed smartphone app and breathalyzer. 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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Meet Diagnostic and Statistical Manual (DSM)-5 criteria for alcohol use disorder - Average 3 or more heavy drinking days (≥5 drinks in one occasion for men, ≥4 for women) per week for the past month on the Timeline Follow-back. - Must endorse alcohol as their primary drug of use. - Express a desire to abstain from drinking.

Exclusion Criteria

  • Are currently enrolled in an alcohol treatment program (not including attendance at Alcoholics Anonymous or similar community support meetings). - Score 23 or greater on the Alcohol Withdrawal Symptom Checklist, a score indicating that medication would be likely required to manage alcohol detoxification. - Pregnant women, lactating women, or women who are planning to become pregnant in the next 15 months.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Group A 		Group A 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 for the first 3 weeks of the intervention. For the remaining 9 weeks they will continue to receive incentives for submitting negative samples.
  • Behavioral: Contingency management
    Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol.
    Other names:
    • Contingent incentives
Active Comparator
Group B 		Group B 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 for the first 3 weeks of the intervention.For the remaining 9 weeks they will not be required to submit breathalyzer samples.
  • Behavioral: Contingency management
    Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol.
    Other names:
    • Contingent incentives
Sham Comparator
Group C 		Group C will receive nearly immediate monetary payments over the internet each day they remotely provide breathalyzer samples regardless of the alcohol content, but will not receive the payments if they fail to provide samples in a timely manner for the first 3 weeks of the intervention. For the remaining 9 weeks they will continue to receive incentives for submitting on time samples regardless of alcohol content.
  • Behavioral: Contingency management
    Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.
    Other names:
    • Noncontingent incentives
Sham Comparator
Group D 		Group D will receive nearly immediate monetary payments over the internet each day they remotely provide breathalyzer samples regardless of the alcohol content, but will not receive the payments if they fail to provide samples in a timely manner for the first 3 weeks of the intervention. For the remaining 9 weeks they will not be required to submit breathalyzer samples.
  • Behavioral: Contingency management
    Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.
    Other names:
    • Noncontingent incentives
No Intervention
Group E 		Group E will have no intervention, they will only complete assessment sessions.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

Nationwide Online Enrollment from the Unversity of Kentucky
Lexington, Kentucky 40504
Contact:
Mikhail N Koffarnus, PhD
859-533-2749
healthful@uky.edu

University of Kentucky Turfland: In-person enrollment
Lexington, Kentucky 40504
Contact:
Mikhail Koffarnus, PhD
healthful@uky.edu

More Details

NCT ID
NCT03883126
Status
Recruiting
Sponsor
Mikhail N Koffarnus

Study Contact

Mikhail N Koffarnus, PhD
8595332749
healthful@uky.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.