NCT04656925

Brief Summary

Alcohol abuse remains a significant cause of preventable morbidity and mortality in the US. Yet only 15% of those with alcohol use disorders receive treatment. Contingency Management (CM) is a cost-effective intervention for drug addiction where individuals are rewarded when they submit biological verification of drug abstinence. The researchers propose to develop an integrated CM system capable of incorporating mobile device input, that would allow them to deliver a CM intervention for problematic drinking to anyone who owns a smartphone. The mobile device input will incorporate ecological momentary assessments (EMA), geospatial mapping, and biomarker-based feedback from a portable measuring device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

March 29, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2021

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

February 5, 2025

Completed
Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

September 15, 2020

Results QC Date

March 7, 2024

Last Update Submit

May 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Biochemically Measured Change in Alcohol Abstinence.

    Change in biochemically measured alcohol abstinence assessed through breath samples submitted three times daily.

    Daily during 8 weeks (2 weeks of first A phase, 4 weeks of B phase, and 2 second A phase)

Secondary Outcomes (2)

  • Feasibility Indicator of App Usage

    8 weeks (2 weeks of first A phase, 4 weeks of B phase, and 2 second A phase)

  • Treatment Retention

    8 Weeks

Study Arms (1)

Contingency management A-B-A

EXPERIMENTAL

All participants will be assigned a single arm where we will utilize an A-B-A, or return to baseline design where all participants will experience the intervention in between two baseline observation periods.

Behavioral: Contingency management

Interventions

Reinforcement, or incentives, in exchange for evidence of not drinking alcohol.

Contingency management A-B-A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years.
  • An Alcohol Use Disorders Identification Test (AUDIT) score of 8 or higher.
  • Ability to read and speak English.
  • Ability to provide written informed consent.
  • Breath alcohol of 0.00 during informed consent.
  • Operate a smartphone with an active service provider.

You may not qualify if:

  • Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) alcohol use disorder, severe type.
  • Significant risk of dangerous alcohol withdrawal, defined as a history of alcohol detoxification or seizure in the last 12 months and expression of concern by the participant about dangerous withdrawal.
  • Diagnosis of a psychotic disorder.
  • Lifetime suicide attempt or suicidality in the past year.
  • Any other medical or psychiatric condition that would compromise safe participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington State University

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Abigail Bowen
Organization
Washington State University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A-B-A, or a return to baseline design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 15, 2020

First Posted

December 7, 2020

Study Start

March 29, 2021

Primary Completion

December 8, 2021

Study Completion

December 8, 2021

Last Updated

May 14, 2026

Results First Posted

February 5, 2025

Record last verified: 2026-05

Locations