Multicentre Trial of Suboxone in Opiate-dependent Subjects in Taiwan

November 28, 2012 updated by: Indivior Inc.

An Open Multi-center Trial of Suboxone® (Buprenorphine/Naloxone) Treatment Among Opiate-Dependent Subjects

To determine whether Suboxone can be effectively used to treat Taiwanese ethnic subjects with opiate dependence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Gueishan, Taiwan
        • Chang-Gung Memorial Hospital, Linkou Branch
      • Keelung, Taiwan, 204
        • Chang-Gung Memorial Hospital, Keelung Branch
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 110
        • Taipei City Hospital - Song De Branch
      • Taipei, Taiwan, 24936
        • Bali Psychiatric Center
    • Tainan County
      • Ren-De, Tainan County, Taiwan
        • Jianan Mental Hospital
    • Taoyuan County
      • Taoyuan City, Taoyuan County, Taiwan, 330
        • Taoyuan Mental Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects, 20 years of age or older at screening visit.
  • Subjects must meet DSM-IV/COWS1,2 criteria for opiate dependence. (COWS total score ≥5)
  • Subjects must have a positive urine drug screen (dipstick test) for an opiate or morphine at study entry
  • Subject is seeking treatment with the desire to discontinue opiate use as an initial goal but willing to consider and accept longer treatment if necessary.
  • Subject is in good physical health or, if he/she has a medical condition needing ongoing treatment, must be in the care of a physician who is willing to take responsibility for such treatment and work with the study physician. Study physicians able to manage the subject for his/her general medical condition, may be assigned this role. These same conditions apply in case of subjects with psychiatric disorder(s) needing ongoing treatment.
  • Subject is agreeable to and capable of signing informed consent form.
  • Females of childbearing potential must have a negative pregnancy test and agree to use a double barrier method or condoms/diaphragm and spermicide contraceptive method during the study.

Exclusion Criteria:

  • Women who are pregnant, lactating or breast feeding.
  • Subjects have any acute medical condition that would make participation, in the opinion of the treating physician or the principal investigator, medically hazardous (e.g., acute hepatitis, unstable cardiovascular, liver or renal disease).
  • Subjects have clinically significant liver disease.
  • Subjects who have demonstrated a previous hypersensitivity to buprenorphine or naloxone.
  • Subjects who are considered an immediate risk for suicide, are acutely psychotic, severely depressed, or in need of inpatient treatment.
  • Subjects who are dependent on alcohol, benzodiazepines or other drugs of abuse (except tobacco) to the point of requiring immediate medical attention.
  • Subjects received methadone treatment within the last 30 days since screening visit.
  • Subjects have any pending legal action that could prohibit continued participation.
  • Subjects have participated in other clinical studies within the past 30 days.
  • Subjects who are expecting to leave the clinic geographic area prior to study completion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Suboxone, maximum 8mg
Drug: Buprenorphine + naloxone (Suboxone)
Sublingual tablets
Other Names:
  • Suboxone
Drug: Buprenorphine + naloxone (Suboxone)
Other Names:
  • Suboxone
Experimental: Buprenorphine + naloxone
Drug: Buprenorphine + naloxone (Suboxone)
Sublingual tablets
Other Names:
  • Suboxone
Drug: Buprenorphine + naloxone (Suboxone)
Other Names:
  • Suboxone
Experimental: Buprenorphine + naloxone (Suboxone)
Drug: Buprenorphine + naloxone (Suboxone)
Sublingual tablets
Other Names:
  • Suboxone
Drug: Buprenorphine + naloxone (Suboxone)
Other Names:
  • Suboxone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retention in treatment
Time Frame: weekly up to 13 weeks
weekly up to 13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indivior Inc.

Collaborators

Taipei City Psychiatric Center, Taiwan

Investigators

  • Principal Investigator: Shih-Ku Lin, MD, Department of Psychiatry, Taipei City Psychiatric Center, Taipei, Taiwan.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

May 13, 2009

First Submitted That Met QC Criteria

May 13, 2009

First Posted (Estimate)

May 14, 2009

Study Record Updates

Last Update Posted (Estimate)

November 30, 2012

Last Update Submitted That Met QC Criteria

November 28, 2012

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BU0808

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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