Linking Opioid Dependent Patients From Inpatient Detoxification to Primary Care

Not Applicable

Completed

• Conditions: Illicit Opioid Drug Use

• Registration Number: NCT01751789
• Lead Sponsor: Butler Hospital

Brief Summary

The purpose of this study is to determine whether, for individuals in inpatient opioid detoxification, linking to outpatient Suboxone treatment increases treatment adherence and reduces relapse to illicit opioid use.

Detailed Description

In this randomized trial, consenting individuals seeking inpatient opioid detoxification will be assigned to one of two groups. The first group will receive a tapering schedule of buprenorphine during inpatient detoxification to alleviate acute withdrawal symptoms, and referral to a community medical and substance abuse treatment providers (DETOX). The second group will also receive buprenorphine to relieve withdrawal symptoms, but will maintain a stable dose of buprenorphine through inpatient discharge and linkage to an appointment with a primary care provider within a week of discharge (LINKAGE). All participants complete study assessments at baseline, 1-month, 3-months and 6-months post-enrollment.

The SSTAR inpatient detoxification program based in Fall River, Massachusetts will serve as the recruitment site of this trial. SSTAR's program has 38 beds and is a 24-hour medically and psychiatrically supervised treatment facility that provides evaluation and withdrawal management. The SSTAR Family Healthcare Center is a 330 Federally Qualified facility also in Fall River that provides primary care and behavioral health services to residents of Community Health Network Area 25 (Fall River, Somerset, Swansea and Westport, Massachusetts). Dr. Bailey, Director of Research at SSTAR, will oversee the provision of buprenorphine treatment to study participants during detoxification and serve as liaison to the primary care providers at the Family Healthcare Center.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-12-14
• Study First Submitted QC: 2012-12-14
• Study First Posted: 2012-12-18
• Primary Completion: 2017-11
• Study Completion: 2018-08
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-03
• Last Update Posted: 2019-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 335

Inclusion Criteria

• 18 years of age or older;
• opioid dependent;
• interested in initiating maintenance buprenorphine treatment;
• opioid positive on urine toxicology;
• willing to establish primary care with a buprenorphine-waivered physician at SSTAR.

Exclusion Criteria

• Patients unable to provide informed consent due to acute illness, cognitive impairment, or psychosis;
• probation/parole requirements that might interfere with protocol participation (1% of SSTAR inpatients);
• inability to provide two contact persons to verify location;
• not able to complete assessments in English;
• currently enrolled in a methadone or suboxone maintenance program;
• plans to leave the area within the next 6 months;
• current DSM-IV diagnosis of substance dependence for sedative/hypnotic drugs, cocaine, or alcohol;
• current suicidality on the Modified Scale for Suicidal Ideation;
• chronic pain requiring ongoing opioid use or anticipated major painful event (significant surgical procedure) in the coming 6 months;
• pregnancy;
• history of allergic reaction to buprenorphine or naloxone.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Illicit opioid use	6 months	Illicit opioid use will be measured by self-report and by urine toxicology
Health Service Utilization	6 months	Health service utilization will be measured by self-report and medical chart review

Trial Locations

Locations (1)

SSTAR; 🇺🇸 Fall River, Massachusetts, United States