Multicentre Trial of Suboxone in Opiate-dependent Subjects in Taiwan

This study has been completed.
Sponsor:
Collaborator:
Taipei City Psychiatric Center, Taiwan
Information provided by (Responsible Party):
Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00901875
First received: May 13, 2009
Last updated: November 28, 2012
Last verified: January 2010
  Purpose

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


Condition Intervention Phase
Opiate Dependence
Drug: Buprenorphine + naloxone (Suboxone)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Multi-center Trial of Suboxone® (Buprenorphine/Naloxone) Treatment Among Opiate-Dependent Subjects

Resource links provided by NLM:


Further study details as provided by Reckitt Benckiser Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Retention in treatment [ Time Frame: weekly up to 13 weeks ] [ Designated as safety issue: No ]

Enrollment: 127
Study Start Date: March 2009
Study Completion Date: January 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Suboxone, maximum 8mg Drug: Buprenorphine + naloxone (Suboxone)
Sublingual tablets
Other Name: Suboxone
Drug: Buprenorphine + naloxone (Suboxone)
Other Name: Suboxone
Experimental: Buprenorphine + naloxone Drug: Buprenorphine + naloxone (Suboxone)
Sublingual tablets
Other Name: Suboxone
Drug: Buprenorphine + naloxone (Suboxone)
Other Name: Suboxone
Experimental: Buprenorphine + naloxone (Suboxone) Drug: Buprenorphine + naloxone (Suboxone)
Sublingual tablets
Other Name: Suboxone
Drug: Buprenorphine + naloxone (Suboxone)
Other Name: Suboxone

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901875

Locations
Taiwan
Jianan Mental Hospital
Ren-De, Tainan County, Taiwan
Taoyuan Mental Hospital
Taoyuan City, Taoyuan County, Taiwan, 330
Chang-Gung Memorial Hospital, Linkou Branch
Gueishan, Taiwan
Chang-Gung Memorial Hospital, Keelung Branch
Keelung, Taiwan, 204
China Medical University Hospital
Taichung, Taiwan, 40447
Taipei Veterans General Hospital
Taipei, Taiwan, 112
BALI Psychiatric Center
Taipei, Taiwan, 24936
Taipei City Hospital - Song De Branch
Taipei, Taiwan, 110
Sponsors and Collaborators
Reckitt Benckiser Pharmaceuticals Inc.
Taipei City Psychiatric Center, Taiwan
Investigators
Principal Investigator: Shih-Ku Lin, MD Department of Psychiatry, Taipei City Psychiatric Center, Taipei, Taiwan.
  More Information

No publications provided

Responsible Party: Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00901875     History of Changes
Other Study ID Numbers: BU0808
Study First Received: May 13, 2009
Last Updated: November 28, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Reckitt Benckiser Pharmaceuticals Inc.:
Buprenorphine
Naloxone
Suboxone

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Buprenorphine
Naloxone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on July 24, 2014