Multicentre Trial of Suboxone in Opiate-dependent Subjects in Taiwan

Condition(s) targeted: Opiate Dependence

Intervention: Buprenorphine + naloxone (Suboxone) (Drug); Buprenorphine + naloxone (Suboxone) (Drug)

Phase: Phase 4

Status: Completed

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.

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

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

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

Primary outcome: Retention in treatment

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.

Chang-Gung Memorial Hospital, Linkou Branch, Gueishan, Taiwan

Chang-Gung Memorial Hospital, Keelung Branch, Keelung 204, Taiwan

China Medical University Hospital, Taichung 40447, Taiwan

BALI Psychiatric Center, Taipei 24936, Taiwan

Taipei City Hospital - Song De Branch, Taipei 110, Taiwan

Taipei Veterans General Hospital, Taipei 112, Taiwan

Jianan Mental Hospital, Ren-De, Tainan County, Taiwan

Taoyuan Mental Hospital, Taoyuan City, Taoyuan County 330, Taiwan

Starting date: March 2009
Last updated: November 28, 2012