Multicentre Trial of Suboxone in Opiate-dependent Subjects in Taiwan

Opiate Dependence Clinical Trial

Official title:

An Open Multi-center Trial of Suboxone® (Buprenorphine/Naloxone) Treatment Among Opiate-Dependent Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00901875
• Other study ID #: BU0808
• Status: Completed
• Phase: Phase 4
• First received: May 13, 2009
• Last updated: November 28, 2012
• Start date: March 2009
• Est. completion date: January 2010

Study information

• Verified date: January 2010
• Source: Indivior Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: January 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opiate Dependence

Intervention

Drug:
• Buprenorphine + naloxone (Suboxone)
Sublingual tablets
• Buprenorphine + naloxone (Suboxone)

Locations

Country	Name	City	State
Taiwan	Chang-Gung Memorial Hospital, Linkou Branch	Gueishan
Taiwan	Chang-Gung Memorial Hospital, Keelung Branch	Keelung
Taiwan	Jianan Mental Hospital	Ren-De	Tainan County
Taiwan	China Medical University Hospital	Taichung
Taiwan	BALI Psychiatric Center	Taipei
Taiwan	Taipei City Hospital - Song De Branch	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Taoyuan Mental Hospital	Taoyuan City	Taoyuan County

Sponsors (2)

Lead Sponsor	Collaborator
Indivior Inc.	Taipei City Psychiatric Center, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention in treatment		weekly up to 13 weeks	No