NCT07129902

Brief Summary

Project Summary The goal of this pilot clinical trial is to assess contingency management (CM) for increasing attendance at outpatient clinics after Medication for Opioid Use Disorder (MOUD) prescription and clinic referral occurred in the hospital Emergency Department (ED).

  • The researchers will compare usual care (UC)+CM to UC alone to see if 1) CM works to promote MOUD clinic attendance after discharge from the ED and 2) demonstrate feasibility of providing CM in the ED and outpatient MOUD clinic settings.
  • Researchers will randomize 30 adults who started MOUD in the ED into two conditions. These conditions consist of (A) UC alone: A referral to an outpatient buprenorphine or methadone provider with reminders from STAR program staff or (B) UC+CM: UC plus financial incentives dependent on MOUD clinic attendance to receive an MOUD prescription. The primary outcome of interest is the number of participants who receive their first MOUD prescription from the outpatient clinic after discharge from the ED in UC+CM compared to the UC-only condition. A secondary outcome will be the proportion of participants who kept attending outpatient MOUD treatment by the end of the 30-day study period between UC+CM and UC conditions. An exploratory outcome will be biochemically-verified illicit opioid abstinence measured at day 30.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress58%
Sep 2025Oct 2026

First Submitted

Initial submission to the registry

August 8, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

August 8, 2025

Last Update Submit

August 14, 2025

Conditions

Keywords

contingency managementmedication for opioid use disorder (MOUD)emergency departmentsopioid use disorder

Outcome Measures

Primary Outcomes (1)

  • Intake at outpatient MOUD clinic

    The proportion of participants who complete their initial (intake) outpatient MOUD clinic appointment after discharge from the emergency department.

    30 days

Secondary Outcomes (1)

  • Attendance at outpatient MOUD clinic

    30 days

Study Arms (2)

Contingency Management

EXPERIMENTAL

Participants assigned to this arm will receive incentives when they complete their first outpatient MOUD clinic visit and when they complete subsequent visits to pick up their MOUD prescription for the 30-day study period.

Behavioral: Contingency ManagementBehavioral: Usual care as prescribed by the ED physicians

Usual Care

ACTIVE COMPARATOR

All participants will receive standard outpatient care at their clinic.

Behavioral: Usual care as prescribed by the ED physicians

Interventions

Participants in the active arm will receive payment (monetary incentive) contingent on outpatient MOUD treatment attendance.

Contingency Management

All participants will receive standard outpatient care at their clinic.

Contingency ManagementUsual Care

Eligibility Criteria

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

You may qualify if:

  • STAR referral to outpatient clinic (Addiction Treatment Center and Chittenden Clinic) with prescription for buprenorphine or methadone.
  • Age ≥18 years.
  • Provide informed consent.

You may not qualify if:

  • Pending incarceration in the next 30 days.
  • Plan to leave the area (Burlington/Chittenden County) in the next 30 days.
  • Physical, health, or structural challenge that prevents attendance at outpatient clinic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersEmergencies

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eric A Thrailkill, Ph.D.

    University of Vermont

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric A Thrailkill, Ph.D.

CONTACT

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
Assistant Professor

Study Record Dates

First Submitted

August 8, 2025

First Posted

August 19, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations