Opiate DependencePhase 4NCT00901875
Multicentre Trial of Suboxone in Opiate-dependent Subjects in Taiwan
A Phase 4 study testing Buprenorphine + naloxone (Suboxone) in people with Opiate Dependence, run by Indivior Inc. at 8 sites in Taiwan.
Trial summary
To determine whether Suboxone can be effectively used to treat Taiwanese ethnic subjects with opiate dependence. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Opiate Dependence
- What is being tested?
- Buprenorphine + naloxone (Suboxone)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 8 sitesTaiwan
- Study dates
- Mar 2009to Jan 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Taiwan8 sites
Chang-Gung Memorial Hospital, Linkou Branch
Guishan
Chang-Gung Memorial Hospital, Keelung Branch
Keelung, 204
Jianan Mental Hospital
Rende, Tainan County
China Medical University Hospital
Taichung, 40447
Taipei City Hospital - Song De Branch
Taipei, 110
Taipei Veterans General Hospital
Taipei, 112
BALI Psychiatric Center
Taipei, 24936
Taoyuan Mental Hospital
Taoyuan City, Taoyuan County, 330
About this study
Official title: An Open Multi-center Trial of Suboxone® (Buprenorphine/Naloxone) Treatment Among Opiate-Dependent Subjects
To determine whether Suboxone can be effectively used to treat Taiwanese ethnic subjects with opiate dependence.
- Conditions
- Opiate Dependence
- Being tested
- Buprenorphine + naloxone (Suboxone)
- Keywords
- Buprenorphine, Naloxone, Suboxone
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine + naloxone (Suboxone)Drug
Also called Suboxone
Sublingual tablets
Buprenorphine + naloxone (Suboxone)Drug
Also called Suboxone
| Study group | Role | What they receive |
|---|---|---|
| Suboxone, maximum 8mg | Experimental | Not described Receives: Drug: Buprenorphine + naloxone (Suboxone) |
| Buprenorphine + naloxone | Experimental | Not described Receives: Drug: Buprenorphine + naloxone (Suboxone) |
| Buprenorphine + naloxone (Suboxone) | Experimental | Not described Receives: Drug: Buprenorphine + naloxone (Suboxone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in treatment
Measured: weekly up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startMar 2009
- Primary completionNov 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indivior Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taipei City Psychiatric Center, Taiwan
- Responsible party
- Sponsor
- Investigators
- Shih-Ku Lin, MD, Principal investigator, Department of Psychiatry, Taipei City Psychiatric Center, Taipei, Taiwan.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901875
- Sponsor's protocol ID
- BU0808
- Status last verified
- Jan 2010
- First submitted
- 13 May 2009
- Last updated
- 30 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Multi-center Trial of Suboxone® (Buprenorphine/Naloxone) Treatment Among Opiate-Dependent Subjects
- ClinicalTrials.gov ID
- NCT00901875
- Acronym / sponsor ID
- BU0808
- Conditions
- Opiate Dependence
- Keywords
- Buprenorphine, Naloxone, Suboxone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Indivior Inc.Industry (pharma, biotech, devices)
- Collaborators
- Taipei City Psychiatric Center, Taiwan
- Study start
- Mar 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 14 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether Suboxone can be effectively used to treat Taiwanese ethnic subjects with opiate dependence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suboxone, maximum 8mg | Experimental | Drug: Buprenorphine + naloxone (Suboxone) |
| Buprenorphine + naloxone | Experimental | Drug: Buprenorphine + naloxone (Suboxone) |
| Buprenorphine + naloxone (Suboxone) | Experimental | Drug: Buprenorphine + naloxone (Suboxone) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buprenorphine + naloxone (Suboxone)Also: SuboxoneSublingual tablets | Drug | Buprenorphine + naloxone, Buprenorphine + naloxone (Suboxone), Suboxone, maximum 8mg |
| Buprenorphine + naloxone (Suboxone)Also: Suboxone | Drug | Buprenorphine + naloxone, Buprenorphine + naloxone (Suboxone), Suboxone, maximum 8mg |
Primary outcome
Retention in treatment
Time frame: weekly up to 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shih-Ku Lin, MD principal investigator
Department of Psychiatry, Taipei City Psychiatric Center, Taipei, Taiwan.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Buprenorphine + naloxone (Suboxone) in people with Opiate Dependence, run by Indivior Inc. at 8 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in treatment (time frame: weekly up to 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2012.