Linking Opioid Dependent Patients From Inpatient Detoxification to Primary Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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Linking Opioid Dependent Patients From Inpatient Detoxification to Primary Care

Conditions
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Illicit Opioid Drug Use

Intervention / Treatment
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* Behavioral: Linkage
* Other: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Linkage<br>Participants will receive Suboxone during their inpatient detoxication and be given outpatient appointments to continue Suboxone treatment after completing inpatient detoxification | Behavioral: Linkage<br> <br> |
| Placebo Comparator: Detoxification<br>Participants will receive Suboxone to detoxify from opioids and the standard treatment offered by the inpatient detoxification program | Other: Treatment as Usual<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Illicit opioid use | Illicit opioid use will be measured by self-report and by urine toxicology | 6 months | 
| Health Service Utilization | Health service utilization will be measured by self-report and medical chart review | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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illicit opioid drug use, health service utilization