Multicentre Trial of Suboxone in Opiate-Dependent Subjects in Taiwan
Information source: Reckitt Benckiser Pharmaceuticals, Inc
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opiate Dependence
Intervention: Buprenorphine + naloxone (Suboxone) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Reckitt Benckiser Pharmaceuticals, Inc Official(s) and/or principal investigator(s):
Shih-Ku Lin, MD, Principal Investigator, Affiliation: Department of Psychiatry, Taipei City Psychiatric Center, Taipei, Taiwan.
Summary
To determine whether Suboxone can be effectively used to treat Taiwanese ethnic subjects
with opiate dependence.
Clinical Details
Official title: An Open Multi-Center Trial of Suboxone® (Buprenorphine/Naloxone) Treatment Among Opiate-Dependent Subjects
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary outcome: Retention in treatment
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
BALI Psychiatric Center, Taipei 24936, Taiwan; Not yet recruiting
Ding-Lieh Liao, MD
Ding-Lieh Liao, MD, Principal Investigator
Chang-Gung Memorial Hospital, Keelung Branch, Keelung 204, Taiwan; Recruiting
Yi-Chih Chen, MD, Phone: +886-2-27135211
Yi-Chih Chen, MD, Principal Investigator
Chang-Gung Memorial Hospital, Linkou Branch, Gueishan, Taiwan; Not yet recruiting
Shih-Chieh Hsu, MD
Shih-Chieh Hsu, MD, Principal Investigator
China Medical University Hospital, Taichung 40447, Taiwan; Recruiting
Chieh-Liang Huang, MD, Email: psyche@mail.cmuh.org.tw
Chieh-Liang Huang, MD, Principal Investigator
Taipei City Hospital - Song De Branch, Taipei 110, Taiwan; Recruiting
Lien-Wen Su, MD, Phone: +886 2 27285791
Lien-Wen Su, MD, Principal Investigator
Taipei Veterans General Hospital, Taipei 112, Taiwan; Recruiting
Tung-Ping Su, MD, Email: tpsu@vghtpe.gov.tw
Tung-Ping Su, MD, Principal Investigator
Jianan Mental Hospital, Ren-De, Tainan County, Taiwan; Not yet recruiting
Hsin-Pei Tan, MD
Hsin-Pei Tang, Principal Investigator
Taoyuan Mental Hospital, Taoyuan City, Taoyuan County 330, Taiwan; Recruiting
Kuy-Lok Tan, MD, Phone: +886-3-369-8553
Kuy-Lok Tan, MD, Principal Investigator
Additional Information
Starting date: March 2009
Ending date: September 2009
Last updated: May 15, 2009
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