Multicentre Trial of Suboxone in Opiate-dependent Subjects in Taiwan
Primary Purpose
Opiate Dependence
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Buprenorphine + naloxone (Suboxone)
Buprenorphine + naloxone (Suboxone)
Sponsored by
About this trial
This is an interventional treatment trial for Opiate Dependence focused on measuring Buprenorphine, Naloxone, Suboxone
Eligibility Criteria
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.
Sites / Locations
- Jianan Mental Hospital
- Taoyuan Mental Hospital
- Chang-Gung Memorial Hospital, Linkou Branch
- Chang-Gung Memorial Hospital, Keelung Branch
- China Medical University Hospital
- Taipei City Hospital - Song De Branch
- Taipei Veterans General Hospital
- BALI Psychiatric Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Suboxone, maximum 8mg
Buprenorphine + naloxone
Buprenorphine + naloxone (Suboxone)
Arm Description
Outcomes
Primary Outcome Measures
Retention in treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT00901875
First Posted
May 13, 2009
Last Updated
November 28, 2012
Sponsor
Indivior Inc.
Collaborators
Taipei City Psychiatric Center, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT00901875
Brief Title
Multicentre Trial of Suboxone in Opiate-dependent Subjects in Taiwan
Official Title
An Open Multi-center Trial of Suboxone® (Buprenorphine/Naloxone) Treatment Among Opiate-Dependent Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indivior Inc.
Collaborators
Taipei City Psychiatric Center, Taiwan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine whether Suboxone can be effectively used to treat Taiwanese ethnic subjects with opiate dependence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence
Keywords
Buprenorphine, Naloxone, Suboxone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Suboxone, maximum 8mg
Arm Type
Experimental
Arm Title
Buprenorphine + naloxone
Arm Type
Experimental
Arm Title
Buprenorphine + naloxone (Suboxone)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Buprenorphine + naloxone (Suboxone)
Other Intervention Name(s)
Suboxone
Intervention Description
Sublingual tablets
Intervention Type
Drug
Intervention Name(s)
Buprenorphine + naloxone (Suboxone)
Other Intervention Name(s)
Suboxone
Primary Outcome Measure Information:
Title
Retention in treatment
Time Frame
weekly up to 13 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shih-Ku Lin, MD
Organizational Affiliation
Department of Psychiatry, Taipei City Psychiatric Center, Taipei, Taiwan.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jianan Mental Hospital
City
Ren-De
State/Province
Tainan County
Country
Taiwan
Facility Name
Taoyuan Mental Hospital
City
Taoyuan City
State/Province
Taoyuan County
ZIP/Postal Code
330
Country
Taiwan
Facility Name
Chang-Gung Memorial Hospital, Linkou Branch
City
Gueishan
Country
Taiwan
Facility Name
Chang-Gung Memorial Hospital, Keelung Branch
City
Keelung
ZIP/Postal Code
204
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taipei City Hospital - Song De Branch
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
BALI Psychiatric Center
City
Taipei
ZIP/Postal Code
24936
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Multicentre Trial of Suboxone in Opiate-dependent Subjects in Taiwan
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