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Linking Opioid Dependent Patients From Inpatient Detoxification to Primary Care

Linking Opioid Dependent Patients From Inpatient Detoxification to Primary Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01751789
Enrollment
335
Registered
2012-12-18
Start date
2012-10-31
Completion date
2018-08-31
Last updated
2019-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Illicit Opioid Drug Use

Keywords

illicit opioid drug use, health service utilization

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.

Interventions

BEHAVIORALLinkage
OTHERTreatment as Usual

Sponsors

Butler Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Illicit opioid use6 monthsIllicit opioid use will be measured by self-report and by urine toxicology
Health Service Utilization6 monthsHealth service utilization will be measured by self-report and medical chart review

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026