Initiating Substance Use Disorder Treatment for Hospitalized Opioid Use Disorder Patients. (ISTOP)
Primary Purpose
Opioid-use Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Recovery coach
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-use Disorder
Eligibility 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
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Control
Arm Description
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.
Subjects randomized to the control arm will receive treatment as usual. This means subjects are linked to ongoing outpatient treatment with buprenorphine or methadone.
Outcomes
Primary Outcome Measures
Treatment Retention
Treatment retention in substance use disorder treatrment
Illicit opioid use
Number of days of illicit opioid use in the prior 30 days
Secondary Outcome Measures
Readmissions
Number of hospital readmissions
Full Information
NCT ID
NCT03212794
First Posted
July 6, 2017
Last Updated
December 30, 2021
Sponsor
Brigham and Women's Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT03212794
Brief Title
Initiating Substance Use Disorder Treatment for Hospitalized Opioid Use Disorder Patients.
Acronym
ISTOP
Official Title
Initiating Substance Use Disorder Treatment for Hospitalized Opioid Use Disorder Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
February 11, 2019 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects randomized to the control arm will receive treatment as usual. This means subjects are linked to ongoing outpatient treatment with buprenorphine or methadone.
Intervention Type
Behavioral
Intervention Name(s)
Recovery coach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment Retention
Description
Treatment retention in substance use disorder treatrment
Time Frame
24 weeks after baseline
Title
Illicit opioid use
Description
Number of days of illicit opioid use in the prior 30 days
Time Frame
24 weeks after baseline
Secondary Outcome Measure Information:
Title
Readmissions
Description
Number of hospital readmissions
Time Frame
24 weeks after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joji Suzuki, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29141667
Citation
Friedmann PD, Suzuki J. More beds are not the answer: transforming detoxification units into medication induction centers to address the opioid epidemic. Addict Sci Clin Pract. 2017 Nov 15;12(1):29. doi: 10.1186/s13722-017-0092-y. No abstract available.
Results Reference
background
Learn more about this trial
Initiating Substance Use Disorder Treatment for Hospitalized Opioid Use Disorder Patients.
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