Increasing MAT Engagement With Financial Incentives

Sponsor
Rowan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04585399
Collaborator
The Cooper Health System (Other)
100
1
2
36
2.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Contingency management
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two group, randomized controlled trial.Two group, randomized controlled trial.
Masking:
Double (Care Provider, Outcomes 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.
Primary Purpose:
Treatment
Official Title:
Increasing MAT Engagement With Contingency Management Among Individuals With Opioid Use Disorder in an ED Bridge Program
Actual Study Start Date :
Jan 27, 2020
Anticipated Primary Completion Date :
Jan 26, 2023
Anticipated Study Completion Date :
Jan 26, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Attendance at first scheduled clinic appointment [1 week]

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

  2. Percentage of sessions where buprenorphine positive urine results was recorded [3-months]

    Urine-verified buprenorphine

  3. Percentage of sessions where opioid free urine results were recorded [3-months]

    Urine-verified opioid abstinence

  4. Treatment acceptability [3-months]

    Participants will evaluate the treatment at the end.

Secondary Outcome Measures

  1. Delay discounting as a correlate of opioid-free urine test results and buprenorphine-positive results [3-months]

    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.

  2. Opioid demand as a correlate of opioid-free urine test results and buprenorphine-positive results [3-months]

    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. Substance-free activities as a correlate of opioid-free urine test results and buprenorphine-positive results [3-months]

    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.

  4. Neurological Soft Signs correlate with treatment success [3-months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cooper University Hospital Camden New Jersey United States 08108

Sponsors and Collaborators

  • Rowan University
  • The Cooper Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rowan University
ClinicalTrials.gov Identifier:
NCT04585399
Other Study ID Numbers:
  • 19-112EX
First Posted:
Oct 14, 2020
Last Update Posted:
Nov 24, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 24, 2021