We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Linking Opioid Dependent Patients From Inpatient Detoxification to Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01751789
Recruitment Status : Recruiting
First Posted : December 18, 2012
Last Update Posted : January 19, 2018
Information provided by (Responsible Party):
Michael Stein, MD, 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.

Condition or disease Intervention/treatment
Illicit Opioid Drug Use Behavioral: Linkage Other: Treatment as Usual

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Linking Opioid Dependent Patients From Inpatient Detoxification to Primary Care
Study Start Date : October 2012
Primary Completion Date : December 2017
Estimated Study Completion Date : August 2018

Arm Intervention/treatment
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
Other: Treatment as Usual

Primary Outcome Measures :
  1. Illicit opioid use [ Time Frame: 6 months ]
    Illicit opioid use will be measured by self-report and by urine toxicology

  2. Health Service Utilization [ Time Frame: 6 months ]
    Health service utilization will be measured by self-report and medical chart review

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751789

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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Stein, MD, Principal Investigator, Butler Hospital
ClinicalTrials.gov Identifier: NCT01751789     History of Changes
Other Study ID Numbers: DA034261
First Posted: December 18, 2012    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

Keywords provided by Michael Stein, MD, Butler Hospital:
illicit opioid drug use
health service utilization

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents