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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

Tracking Information
First Submitted Date  ICMJE March 9, 2020
First Posted Date  ICMJE October 14, 2020
Last Update Posted Date November 24, 2021
Actual Study Start Date  ICMJE January 27, 2020
Estimated Primary Completion Date January 26, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2020)
  • 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
  • Percentage of sessions where buprenorphine positive urine results was recorded [ Time Frame: 3-months ]
    Urine-verified buprenorphine
  • Percentage of sessions where opioid free urine results were recorded [ Time Frame: 3-months ]
    Urine-verified opioid abstinence
  • Treatment acceptability [ Time Frame: 3-months ]
    Participants will evaluate the treatment at the end.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Increasing MAT Engagement With Financial Incentives
Official Title  ICMJE Increasing MAT Engagement With Contingency Management Among Individuals With Opioid Use Disorder in an ED Bridge Program
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Opioid-use Disorder
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Contingency management
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 6, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 26, 2023
Estimated Primary Completion Date January 26, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Bethany Raiff, PhD 856-256-4500 ext 53782 raiff@rowan.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04585399
Other Study ID Numbers  ICMJE 19-112EX
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Rowan University
Study Sponsor  ICMJE Rowan University
Collaborators  ICMJE The Cooper Health System
Investigators  ICMJE Not Provided
PRS Account Rowan University
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP