Increasing MAT Engagement With Financial Incentives

Increasing MAT Engagement With Contingency Management Among Individuals With Opioid Use Disorder in an ED Bridge Program

The increased prevalence of opioid use disorder (OUD) and associated overdoses and adverse events has led to a substantial increase in the number of patients being seen at emergency departments (ED). Thus, the ED may be an ideal location for identifying patients in need of OUD treatment and can serve as the first touch point in the OUD continuum of care to promote medication assisted treatment initiation. Contingency management (CM) is an effective method for promoting treatment initiation and adherence that has not been thoroughly evaluated for this purpose. The primary aim of the current study is to develop and assess the effectiveness, acceptability, and feasibility of a protocol for delivering CM to increase combined buprenorphine + nalaxone (referred to as BUP hereafter) initiation and continuous adherence for OUD in an existing ED "bridge" program (e.g., Bridge plus CM; B+CM) relative to standard care. Secondary objectives include identifying behavioral and neuropsychological correlates to treatment outcomes, including delay discounting, reinforcer demand, and neurological soft signs.

Study Overview

• Status: Recruiting
• Conditions: Opioid-use Disorder
• Intervention / Treatment: Behavioral: Contingency management

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bethany Raiff, PhD; Phone Number: 53782 856-256-4500; Email: raiff@rowan.edu

Study Locations

• United States
  • New Jersey
    • Camden, New Jersey, United States, 08108
      • Recruiting
      • Cooper University Hospital
      • Contact: Bethany Raiff, PhD; Phone Number: 5-3782 856-256-4500; Email: raiff@rowan.edu
      • Principal Investigator: Bethany Raiff, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Participants at least 18 years of age
2. Participants must be newly enrolled in the Bridge program in the Cooper University ED, with their first clinic appointment scheduled to take place at the Cooper Outreach Clinic within one week of enrollment.
3. All subjects must be in good physical health as determined by a physical examination and premenopausal women will have a pregnancy test on the day of the study to rule out pregnancy

Exclusion Criteria:

1. Participants who demonstrate contraindication with Suboxone treatment or who are currently or have recently used other medication-assisted therapies for opioid use disorder.
2. Participants who are currently pregnant or breastfeeding or have been diagnosed with a DSM-5 psychiatric condition that might interfere with treatment delivery (e.g., uncontrolled schizophrenia, bipolar disorder, dementia)
3. Participants who are non-English speaking or cannot otherwise provide valid informed consent.
4. Individuals who are unable to complete the survey assessments, due to literacy or visual impairments.
5. The participant will not be a prisoner

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Contingency Management; Participants in this arm of the study will receive financial incentives for attending their buprenorphine appointments and for being clean from other opioids. Participants in this group will also have up to two rides per week paid for to attend bup appointments.	Behavioral: Contingency management; Financial incentives for attending bup appointments and demonstrating opioid abstinence. Rides will also be provided for up to two clinic visits per week.
No Intervention: Standard Care; Participants in this group will be treatment as usual and will not receive any incentives for attending their bup appointments or for being opioid abstinent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance at first scheduled clinic appointment	We will track attendance at participant's first scheduled BUP appointment after being bridged from the ED	1 week
Percentage of sessions where buprenorphine positive urine results was recorded	Urine-verified buprenorphine	3-months
Percentage of sessions where opioid free urine results were recorded	Urine-verified opioid abstinence	3-months
Treatment acceptability	Participants will evaluate the treatment at the end.	3-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delay discounting as a correlate of opioid-free urine test results and buprenorphine-positive results	Delay discounting will be evaluated, using the brief, five question delay discounting procedure and will be correlated with urine results determining opioid abstinence and buprenorphine adherence.	3-months
Opioid demand as a correlate of opioid-free urine test results and buprenorphine-positive results	The opioid purchasing task will be used to evaluate opioid demand and will be correlated with urine results determining opioid abstinence and buprenorphine adherence.	3-months
Substance-free activities as a correlate of opioid-free urine test results and buprenorphine-positive results	A modified Pleasant Events Scale survey will be used to evaluate access to, and enjoyment from, substance-free activities and the results will be correlated with urine results determining opioid abstinence and buprenorphine adherence.	3-months
Neurological Soft Signs correlate with treatment success	Participants will complete a drawing task that has been correlated with other substance use treatment outcomes in the past.	3-months

Collaborators and Investigators

• Sponsor: Rowan University
• Collaborators: The Cooper Health System

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2020
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 19-112EX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We will share the data after we have completed the study and have published all of the outcomes. We will only share the data with qualified researchers who provide a written request with clear justification for their need to access the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No