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Trial record 2 of 3 for:    Raiff

Increasing MAT Engagement With Financial Incentives

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04585399
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : November 24, 2021
Sponsor:
Collaborator:
The Cooper Health System
Information provided by (Responsible Party):
Rowan University

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
Opioid-use Disorder Behavioral: Contingency management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 : January 27, 2020
Estimated Primary Completion Date : January 26, 2023
Estimated Study Completion Date : January 26, 2023

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.



Primary Outcome Measures :
  1. Attendance at first scheduled clinic appointment [ Time Frame: 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 [ Time Frame: 3-months ]
    Urine-verified buprenorphine

  3. Percentage of sessions where opioid free urine results were recorded [ Time Frame: 3-months ]
    Urine-verified opioid abstinence

  4. Treatment acceptability [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3-months ]
    Participants will complete a drawing task that has been correlated with other substance use treatment outcomes in the past.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04585399


Contacts
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Contact: Bethany Raiff, PhD 856-256-4500 ext 53782 raiff@rowan.edu

Locations
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United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08108
Contact: Bethany Raiff, PhD    856-256-4500 ext 5-3782    raiff@rowan.edu   
Principal Investigator: Bethany Raiff, PhD         
Sponsors and Collaborators
Rowan University
The Cooper Health System
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Responsible Party: Rowan University
ClinicalTrials.gov Identifier: NCT04585399    
Other Study ID Numbers: 19-112EX
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders