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Increasing MAT Engagement With Financial Incentives

Primary Purpose

Opioid-use Disorder

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Contingency management

About this trial

This is an interventional treatment trial for Opioid-use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Participants at least 18 years of age
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.
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:

Participants who demonstrate contraindication with Suboxone treatment or who are currently or have recently used other medication-assisted therapies for opioid use disorder.
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)
Participants who are non-English speaking or cannot otherwise provide valid informed consent.
Individuals who are unable to complete the survey assessments, due to literacy or visual impairments.
The participant will not be a prisoner

Sites / Locations

Cooper University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Contingency Management

Standard Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Attendance at first scheduled clinic appointment

We will track attendance at participant's first scheduled BUP appointment after being bridged from the ED

Percentage of sessions where buprenorphine positive urine results was recorded

Urine-verified buprenorphine

Percentage of sessions where opioid free urine results were recorded

Urine-verified opioid abstinence

Treatment acceptability

Participants will evaluate the treatment at the end.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT04585399

First Posted

March 9, 2020

Last Updated

July 12, 2023

Sponsor

Rowan University

Collaborators

The Cooper Health System

1. Study Identification

Unique Protocol Identification Number

NCT04585399

Brief Title

Increasing MAT Engagement With Financial Incentives

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 27, 2020 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rowan University

Collaborators

The Cooper Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid-use Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Two group, randomized controlled trial.

Masking

Care ProviderOutcomes Assessor

Masking Description

Participants will only told if they are assigned to the contingency management group because there are different procedures for those individuals. The care providers will not know which participants are in the control group but they may know when people are in the CM group because extra urine screens will be collected and they will be scheduled for rides.

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Contingency Management

Arm Type

Experimental

Arm Description

Arm Title

Standard Care

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Contingency management

Intervention Description

Financial incentives for attending bup appointments and demonstrating opioid abstinence. Rides will also be provided for up to two clinic visits per week.

Primary Outcome Measure Information:

Title

Attendance at first scheduled clinic appointment

Description

We will track attendance at participant's first scheduled BUP appointment after being bridged from the ED

Time Frame

1 week

Title

Percentage of sessions where buprenorphine positive urine results was recorded

Description

Urine-verified buprenorphine

Time Frame

3-months

Title

Percentage of sessions where opioid free urine results were recorded

Description

Urine-verified opioid abstinence

Time Frame

3-months

Title

Treatment acceptability

Description

Participants will evaluate the treatment at the end.

Time Frame

3-months

Secondary Outcome Measure Information:

Title

Delay discounting as a correlate of opioid-free urine test results and buprenorphine-positive results

Description

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.

Time Frame

3-months

Title

Opioid demand as a correlate of opioid-free urine test results and buprenorphine-positive results

Description

The opioid purchasing task will be used to evaluate opioid demand and will be correlated with urine results determining opioid abstinence and buprenorphine adherence.

Time Frame

3-months

Title

Substance-free activities as a correlate of opioid-free urine test results and buprenorphine-positive results

Description

Time Frame

3-months

Title

Neurological Soft Signs correlate with treatment success

Description

Participants will complete a drawing task that has been correlated with other substance use treatment outcomes in the past.

Time Frame

3-months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants at least 18 years of age 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. 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: Participants who demonstrate contraindication with Suboxone treatment or who are currently or have recently used other medication-assisted therapies for opioid use disorder. 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) Participants who are non-English speaking or cannot otherwise provide valid informed consent. Individuals who are unable to complete the survey assessments, due to literacy or visual impairments. The participant will not be a prisoner

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bethany Raiff, PhD

Phone

856-256-4500

Ext

53782

raiff@rowan.edu

Facility Information:

Facility Name

Cooper University Hospital

City

Camden

State/Province

New Jersey

ZIP/Postal Code

08108

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bethany Raiff, PhD

Phone

856-256-4500

Ext

5-3782

raiff@rowan.edu

First Name & Middle Initial & Last Name & Degree

Bethany Raiff, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing 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.

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Increasing MAT Engagement With Financial Incentives

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