Linking Opioid Dependent Patients From Inpatient Detoxification to Primary Care

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Butler Hospital
Sponsor:
Collaborator:
Stanley Street Treatment and Resources, Fall River, MA
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital
ClinicalTrials.gov Identifier:
NCT01751789
First received: December 14, 2012
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Illicit Opioid Drug Use
Behavioral: Linkage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Linking Opioid Dependent Patients From Inpatient Detoxification to Primary Care

Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • Illicit opioid use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Illicit opioid use will be measured by self-report and by urine toxicology

  • Health Service Utilization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Health service utilization will be measured by self-report and medical chart review


Estimated Enrollment: 370
Study Start Date: October 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Linkage
Participants will receive Suboxone during their inpatient detoxication and be given outpatient appointments to continue Suboxone treatment after completing inpatient detoxification
Behavioral: Linkage
Placebo Comparator: Detoxification
Participants will receive Suboxone to detoxify from opioids and the standard treatment offered by the inpatient detoxification program

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751789

Contacts
Contact: Genie Bailey, MD 508-679-5222
Contact: Michael Stein, MD 401-455-6646

Locations
United States, Massachusetts
SSTAR Recruiting
Fall River, Massachusetts, United States, 02720
Contact: Michael Stein, MD    401-455-6646      
Principal Investigator: Genie Bailey, MD         
Sponsors and Collaborators
Butler Hospital
Stanley Street Treatment and Resources, Fall River, MA
  More Information

No publications provided

Responsible Party: Michael Stein, MD, Principal Investigator, Butler Hospital
ClinicalTrials.gov Identifier: NCT01751789     History of Changes
Other Study ID Numbers: DA034261
Study First Received: December 14, 2012
Last Updated: July 16, 2014
Health Authority: United States: National Institutes of Health

Keywords provided by Butler Hospital:
illicit opioid drug use
health service utilization

ClinicalTrials.gov processed this record on September 18, 2014