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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
127

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indivior Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Taipei City Psychiatric Center, Taiwan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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