NCT04064463

Brief Summary

Phosphatidylethanol (PEth) is a direct biomarker of alcohol that can detect moderate to heavy drinking with high sensitivity and specificity over 3-week periods. Reinforcing negative PEth results alongside attendance may increase the proportion of participants who respond to CM during and post treatment. In the proposed study, the investigators will collect PEth samples every 3 weeks for 12 weeks in 150 participants initiating outpatient treatment for alcohol use disorders. Using a two-group randomized design, participants will be assigned to standard care with PEth monitoring alone or with CM for attending treatment and submitting PEth negative samples. Compared to standard care and monitoring, the investigators expect that the CM intervention will result in greater attendance, more PEth negative samples, and higher proportions of self-reported non-drinking days, along with lower proportions of heavy drinking days, over the short term and the long term, measured throughout a 12-month follow-up. The investigators anticipate that the reinforcement intervention may decrease other drug use and sexual risk behaviors that spread HIV, reduce psychiatric symptoms, and improve quality of life as well.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 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

August 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

January 22, 2020

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2025

Completed
Last Updated

February 9, 2026

Status Verified

December 1, 2025

Enrollment Period

5.8 years

First QC Date

August 20, 2019

Last Update Submit

February 4, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Group attendance

    longest consecutive days attended groups

    12 weeks

  • Alcohol abstinence

    number of negative PEth samples

    12 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Standard care

Behavioral: Standard care

Experimental Group

EXPERIMENTAL

Standard care plus contingency management

Behavioral: Standard careBehavioral: Contingency management

Interventions

Participants can earn reinforcement for attending group and abstinence from alcohol

Experimental Group
Standard careBEHAVIORAL

standard treatment for substance use disorders, along with sample monitoring

Control GroupExperimental Group

Eligibility Criteria

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

You may qualify if:

  • in intensive outpatient treatment
  • DSM-5 diagnosis of an alcohol use disorder

You may not qualify if:

  • have a condition that may hinder study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Village

Hartford, Connecticut, 06105, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Sheila Alessi, Ph.D.

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 20, 2019

First Posted

August 22, 2019

Study Start

January 22, 2020

Primary Completion

November 25, 2025

Study Completion

November 25, 2025

Last Updated

February 9, 2026

Record last verified: 2025-12

Locations