Increasing MAT Engagement With Financial Incentives

Opioid-use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04585399
• Other study ID #: 19-112EX
• Status: Recruiting
• Phase: N/A
• Start date: January 27, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: July 2023
• Source: Rowan University
• Contact: Bethany Raiff, PhD
• Phone: 856-256-4500
• Email: raiff[@]rowan.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Cooper University Hospital	Camden	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rowan University	The Cooper Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Percentage of sessions where buprenorphine positive urine results was recorded	Urine-verified buprenorphine	3-months
Primary	Percentage of sessions where opioid free urine results were recorded	Urine-verified opioid abstinence	3-months
Primary	Treatment acceptability	Participants will evaluate the treatment at the end.	3-months
Secondary	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
Secondary	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
Secondary	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
Secondary	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