Clinical trial NCT03212794: Initiating Substance Use Disorder Treatment for Hospitalized Opioid Use Disorder Patients.
Official title: Initiating Substance Use Disorder Treatment for Hospitalized Opioid Use Disorder Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-07-11
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment Retention
timeFrame: 24 weeks after baseline
Secondary outcomes:
measure: Readmissions
timeFrame: 24 weeks after baseline
measure: Days to Treatment Discontinuation
timeFrame: 24 weeks after baseline
measure: Days to Hospital Readmission
timeFrame: 24 weeks after baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Joji Suzuki, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.