Multicentre Trial of Suboxone in Opiate-dependent Subjects in Taiwan
NCT ID: NCT00901875
Last Updated: 2012-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
127 participants
INTERVENTIONAL
2009-03-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Suboxone, maximum 8mg
Buprenorphine + naloxone (Suboxone)
Sublingual tablets
Buprenorphine + naloxone (Suboxone)
Buprenorphine + naloxone
Buprenorphine + naloxone (Suboxone)
Sublingual tablets
Buprenorphine + naloxone (Suboxone)
Buprenorphine + naloxone (Suboxone)
Buprenorphine + naloxone (Suboxone)
Sublingual tablets
Buprenorphine + naloxone (Suboxone)
Interventions
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Buprenorphine + naloxone (Suboxone)
Sublingual tablets
Buprenorphine + naloxone (Suboxone)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
ALL
No
Sponsors
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Taipei City Psychiatric Center, Taiwan
OTHER
Indivior Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Shih-Ku Lin, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Psychiatry, Taipei City Psychiatric Center, Taipei, Taiwan.
Locations
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Jianan Mental Hospital
Rende, Tainan County, Taiwan
Taoyuan Mental Hospital
Taoyuan, Taoyuan County, Taiwan
Chang-Gung Memorial Hospital, Linkou Branch
Guishan, , Taiwan
Chang-Gung Memorial Hospital, Keelung Branch
Keelung, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taipei City Hospital - Song De Branch
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
BALI Psychiatric Center
Taipei, , Taiwan
Countries
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Other Identifiers
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BU0808
Identifier Type: -
Identifier Source: org_study_id