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

NCT03212794 | Completed Results DMC

• 2 other identifiers: 2017P0010361K23DA042326-01A1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Readmissions

  24 weeks after baseline

• Days to Treatment Discontinuation

  24 weeks after baseline

• Days to Hospital Readmission

  24 weeks after baseline

Study Arms (2)

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

Control

NO INTERVENTION

Subjects randomized to the control arm will receive treatment as usual. This means subjects are linked to ongoing outpatient treatment with buprenorphine or methadone.

Interventions

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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related 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.

  PMID: 29141667 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

Pilot study with a small sample size. Because of the launch of a "bridge" clinic at the hospital briefly after trial initiation, participants in both treatment arms may have had access to peer support, potentially diluting the impact of the intervention. Self-report used to ascertain MOUD treatment retention when medical records were not available to be examined. Illicit opioid use after hospital discharge relied on self-report without any toxicologic confirmation.

Results Point of Contact

• Title: Joji Suzuki, MD
• Organization: Brigham and Women's Hospital

Jsuzuki2@bwh.harvard.edu

617-732-5752

Study Officials

• Joji Suzuki, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Addiction Psychiatry

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 11, 2017
• Study Start: February 11, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: December 26, 2023
• Results First Posted: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)