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OpenTrials
Completed

NCT Number: NCT03212794

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English speaking, adults aged 18-75
  • Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis of 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

Treatment and study plan

Recovery coach

Behavioral

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 outcomes

  1. Treatment Retention

    Time frame: 24 weeks after baseline

    Primary outcome was retention in MOUD treatment at 6-months after discharge. If referred to programs affiliated with Brigham and Women's Hospital (BWH), the electronic health records were used to confirm treatment retention. Otherwise, retention was determined through self-report or confirmation with collateral contacts. If the electronic health record was not available for confirmation and the participant was lost to follow-up, the missing data was imputed as discontinuation of MOUD treatment.

Secondary outcomes

  1. Readmissions

    Time frame: 24 weeks after baseline

    Percentage of participants experiencing hospital readmission at 6 months. The electronic health records were used to establish hospital readmission.

  2. Days to Treatment Discontinuation

    Time frame: 24 weeks after baseline

    Number of days until MOUD treatment discontinuation. If referred to programs affiliated with BWH, the electronic health records were used to confirm treatment retention. Otherwise, retention was determined through self-report or confirmation with collateral contacts. If the electronic health record was not available for confirmation and the participant was lost to follow-up, the missing data was imputed as discontinuation of MOUD treatment.

  3. Days to Hospital Readmission

    Time frame: 24 weeks after baseline

    Number of days until hospital readmission. Electronic health records were used to establish hospital readmission.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: ISTOP

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 11, 2017
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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