Multicentre Trial of Suboxone in Opiate-dependent Subjects in Taiwan

NCT00901875 | Completed Phase 4

• 1 other identifier: BU0808
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Opiate Dependence

Keywords

Buprenorphine; Naloxone; Suboxone

Outcome Measures

Primary Outcomes (1)

• Retention in treatment

  weekly up to 13 weeks

Study Arms (3)

Suboxone, maximum 8mg

EXPERIMENTAL

Drug: Buprenorphine + naloxone (Suboxone)

Buprenorphine + naloxone

EXPERIMENTAL

Drug: Buprenorphine + naloxone (Suboxone)

Buprenorphine + naloxone (Suboxone)

EXPERIMENTAL

Drug: Buprenorphine + naloxone (Suboxone)

Interventions

Buprenorphine + naloxone (Suboxone) DRUG

Sublingual tablets

Also known as: Suboxone

Buprenorphine + naloxone; Buprenorphine + naloxone (Suboxone); Suboxone, maximum 8mg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indivior Inc.: lead
• Taipei City Psychiatric Center, Taiwan: collaborator

Study Sites (8)

Jianan Mental Hospital

Rende, Tainan County, Taiwan

Location

Taoyuan Mental Hospital

Taoyuan, Taoyuan County, 330, Taiwan

Location

Chang-Gung Memorial Hospital, Linkou Branch

Guishan, Taiwan

Location

Chang-Gung Memorial Hospital, Keelung Branch

Keelung, 204, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Taipei City Hospital - Song De Branch

Taipei, 110, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

BALI Psychiatric Center

Taipei, 24936, Taiwan

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine; Naloxone; Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Shih-Ku Lin, MD

  Department of Psychiatry, Taipei City Psychiatric Center, Taipei, Taiwan.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 14, 2009
• Study Start: March 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: January 1, 2010
• Last Updated: November 30, 2012

Record last verified: 2010-01

Locations

TW (8)