Clinical trial NCT00901875: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opiate Dependence
Keywords: Buprenorphine
Naloxone
Suboxone
Lead sponsor: Indivior Inc.
Sponsor class: INDUSTRY
Collaborators: name: Taipei City Psychiatric Center, Taiwan
First posted: 2009-05-14
Enrollment: 127
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Retention in treatment
timeFrame: weekly up to 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ren-De
country: Taiwan
facility: Jianan Mental Hospital
state: Tainan County
city: Taoyuan City
country: Taiwan
facility: Taoyuan Mental Hospital
state: Taoyuan County
city: Gueishan
country: Taiwan
facility: Chang-Gung Memorial Hospital, Linkou Branch
city: Keelung
country: Taiwan
facility: Chang-Gung Memorial Hospital, Keelung Branch
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei City Hospital - Song De Branch
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: BALI Psychiatric Center
Study officials:
affiliation: Department of Psychiatry, Taipei City Psychiatric Center, Taipei, Taiwan.
name: Shih-Ku Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: