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Initiating Substance Use Disorder Treatment for Hospitalized Opioid Use Disorder Patients. (ISTOP)

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ClinicalTrials.gov Identifier: NCT03212794
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Joji Suzuki, Brigham and Women's Hospital

Brief Summary:
The purpose of this 24-week study is to evaluate the impact of recovery coach intervention on rates of treatment retention, illicit opioid use, and readmission among hospitalized patients newly initiated on buprenorphine or methadone compared to the control intervention.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Behavioral: Recovery coach Not Applicable

Detailed Description:
Patients with opioid use disorder (OUD) frequently utilize hospitals due to soft tissue infections and other conditions that require inpatient level of care. Prior studies have indicated that OUD patients are often amenable to initiating buprenorphine treatment and can be successfully linked to outpatient treatment. However, hospitalized OUD patients initiated on buprenorphine have much lower treatment retention rates at 6-months compared to OUD patients initiating treatment in the outpatient setting. As such, there is a great need to identify strategies to improve treatment retention in this patient population. There is a growing body of evidence for the benefits of recovery coaches, who provide peer-delivered support services in the community. Tracing their origin to mutual support groups to supplement traditional clinical services, recovery coaches are individuals with lived experience of recovery. Studies of recovery coaches have demonstrated greater treatment retention, reduced substance use, and reduced inpatient utilization. However, no prior studies have examined the impact of recovery coaches in improving medication-assisted treatment retention. As such, the aim of this 24-week study is to evaluate the impact of recovery coach intervention on rates of treatment retention, illicit opioid use, and readmission among hospitalized patients newly initiated on buprenorphine or methadone compared to the control intervention. Patients who are successfully initiated on buprenorphine or methadone, and are willing to engage in treatment after discharge, will be eligible to enroll. Assessments will be conducted at baseline, 4 weeks, 12 weeks, and 24 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Initiating Substance Use Disorder Treatment for Hospitalized Opioid Use Disorder Patients.
Actual Study Start Date : February 11, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: Experimental
Subjects randomized to the experimental arm will be assigned to a recovery coach.In addition to being linked to a community buprenorphine or methadone treatment program, the recovery coach will work to meet weekly with the subject following discharge from the hospital to provide support.
Behavioral: Recovery coach
The recovery coach will support the subjects in the following areas: 1) monitor and manage symptoms, 2) patient education and self-management, and 3) enlisting community and social supports. Encouragement to continue treatment will be a primary focus of the recovery coach. In addition, the coach will conduct weekly sessions on various topics and offer personal insights and facilitate a discussion.

No Intervention: Control
Subjects randomized to the control arm will receive treatment as usual. This means subjects are linked to ongoing outpatient treatment with buprenorphine or methadone.



Primary Outcome Measures :
  1. Treatment Retention [ Time Frame: 24 weeks after baseline ]
    Treatment retention in substance use disorder treatrment

  2. Illicit opioid use [ Time Frame: 24 weeks after baseline ]
    Number of days of illicit opioid use in the prior 30 days


Secondary Outcome Measures :
  1. Readmissions [ Time Frame: 24 weeks after baseline ]
    Number of hospital readmissions



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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:

  • English speaking, adults aged 18-75
  • DSM-5 opioid use disorder, severe, actively using illicit opioids until the time of hospitalization
  • Have a working telephone
  • Can identify at least 2 individuals who can act as points of contact following discharge from the hospital
  • Willing to engage in treatment (either a psychosocial treatment program AND/OR medication treatment with methadone or buprenorphine)

Exclusion Criteria:

  • Liver function test >3x upper normal limit
  • Pregnant
  • Psychotic disorder, active suicidality or homicidality
  • Condition likely to be terminal in 24 weeks such as cancer
  • Unable to perform consent due to mental status
  • Engaged in substance abuse treatment in the last month prior to admission

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): NCT03212794


Contacts
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Contact: Joji Suzuki, MD 617-732-5752 jsuzuki2@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Joji Suzuki, MD         
Principal Investigator: Joji Suzuki, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Joji Suzuki, MD Brigham and Women's Hospital

Publications:
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Responsible Party: Joji Suzuki, Director, Division of Addiction Psychiatry, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03212794     History of Changes
Other Study ID Numbers: 2017P001036
1K23DA042326-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Disease
Substance-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders