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

Opioid-use Disorder Clinical Trial

— ISTOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03212794
• Other study ID #: 2017P001036
• Secondary ID: 1K23DA042326-01A
• Status: Completed
• Phase: N/A
• Start date: February 11, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: December 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Retention	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.	24 weeks after baseline
Secondary	Readmissions	Percentage of participants experiencing hospital readmission at 6 months. The electronic health records were used to establish hospital readmission.	24 weeks after baseline
Secondary	Days to Treatment Discontinuation	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.	24 weeks after baseline
Secondary	Days to Hospital Readmission	Number of days until hospital readmission. Electronic health records were used to establish hospital readmission.	24 weeks after baseline