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Trial record 54 of 186 for:    BUPRENORPHINE AND NALOXONE

Multicentre Trial of Suboxone in Opiate-dependent Subjects in Taiwan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00901875
Recruitment Status : Completed
First Posted : May 14, 2009
Last Update Posted : November 30, 2012
Taipei City Psychiatric Center, Taiwan
Information provided by (Responsible Party):
Indivior Inc.

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

Condition or disease Intervention/treatment Phase
Opiate Dependence Drug: Buprenorphine + naloxone (Suboxone) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Multi-center Trial of Suboxone® (Buprenorphine/Naloxone) Treatment Among Opiate-Dependent Subjects
Study Start Date : March 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Retention in treatment [ Time Frame: weekly up to 13 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00901875

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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 City Hospital - Song De Branch
Taipei, Taiwan, 110
Taipei Veterans General Hospital
Taipei, Taiwan, 112
BALI Psychiatric Center
Taipei, Taiwan, 24936
Sponsors and Collaborators
Indivior Inc.
Taipei City Psychiatric Center, Taiwan
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Principal Investigator: Shih-Ku Lin, MD Department of Psychiatry, Taipei City Psychiatric Center, Taipei, Taiwan.

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Responsible Party: Indivior Inc. Identifier: NCT00901875     History of Changes
Other Study ID Numbers: BU0808
First Posted: May 14, 2009    Key Record Dates
Last Update Posted: November 30, 2012
Last Verified: January 2010
Keywords provided by Indivior Inc.:
Additional relevant MeSH terms:
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Buprenorphine, Naloxone Drug Combination
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists