ISTOP: Initiating Substance Use Disorder Treatment for Hospitalized Opioid Use Disorder Patients.

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03212794
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
26
1
2
34.6
0.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Recovery coach
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
26 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 :
Feb 11, 2019
Actual Primary Completion Date :
Dec 30, 2021
Actual Study Completion Date :
Dec 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Treatment Retention [24 weeks after baseline]

    Treatment retention in substance use disorder treatrment

  2. Illicit opioid use [24 weeks after baseline]

    Number of days of illicit opioid use in the prior 30 days

Secondary Outcome Measures

  1. Readmissions [24 weeks after baseline]

    Number of hospital readmissions

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brigham and Women's Hospital Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Brigham and Women's Hospital
  • National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Joji Suzuki, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Joji Suzuki, MD, Director, Division of Addiction Psychiatry, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT03212794
Other Study ID Numbers:
  • 2017P001036
  • 1K23DA042326-01A1
First Posted:
Jul 11, 2017
Last Update Posted:
Jan 3, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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 Jan 3, 2022