Opiate DependencePhase 4NCT00605033
A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)
A Phase 4 study testing Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484 and Subutex, Buprenorphine Hydrochloride, SCH 28444 in people with Opiate Dependence and Drug Dependence, run by Indivior Inc..
Trial summary
Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Opiate Dependence, Drug Dependence
- What is being tested?
- Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484 and Subutex, Buprenorphine Hydrochloride, SCH 28444
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to May 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must be males or non-pregnant, non-lactating females.
- Subjects must be at least 15 years of age, of either sex, and any race.
- Subjects (and/or the parent or guardian for subjects under the age of legal consent or who otherwise are unable to provide independent consent) must demonstrate willingness to participate in the study and to adhere to dose and visit schedules.
- Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria(18) for opioid dependence.
- Subjects must have been receiving maintenance treatment with Subutex at doses ranging from 4 mg to the maximum dose permitted by country labeling requirements, but not to exceed 24 mg/day, for at least 1 month prior to screening.
- Subjects must not, according to self-report, have injected opioids more than four times in the month prior to screening.
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- Subjects must have an opioid-negative urine drug screening (UDS) result prior to randomization.
- Each subject must confirm that he or she is practicing adequate contraception.
- Female subjects of childbearing potential must have a negative urine beta-human chorionic gonadotropin (β-hCG) test prior to enrollment in the study.
Who cannot join
- Subjects for whom treatment with either Subutex or Suboxone as required in the protocol would be inconsistent with national labeling.
- Subjects who are unwilling or unable to comply with the requirements of the protocol (eg, pending incarceration) or are in a situation or condition that, in the opinion of the investigator, may interfere with participation in the study.
- Subjects who are participating in any other clinical study in which medication(s) are being delivered.
- Subjects with known allergy or sensitivity to naloxone.
- Subjects who are on the staff, affiliated with, or a family member of the staff personnel directly involved with this study.
- Subjects must not have serious untreated Axis I DSM-IV-TR psychiatric comorbidity (eg, those who are actively suicidal or homicidal, have untreated schizophrenia, etc). Polysubstance abuse or dependence will not exclude subjects except in the case of unauthorized and significant benzodiazepine use requiring medical detoxification or alcohol dependence requiring medical detoxification.
- Human immunodeficiency virus (HIV)-positive subjects with clinical acquired immunodeficiency syndrome (AIDS).
- Subjects treated with generic buprenorphine.
About this study
Official title: A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects
Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone.
- Conditions
- Opiate Dependence, Drug Dependence
- Being tested
- Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484, Subutex, Buprenorphine Hydrochloride, SCH 28444
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484Drug
Suboxone sublingual tablet 4 mg/1 mg - 24 mg/6 mg, daily for 28 days
Subutex, Buprenorphine Hydrochloride, SCH 28444Drug
Subutex sublingual tablet 4-24 mg, daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Suboxone | Active comparator | Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) during Weeks 2-4 with weekly access to take-home doses as of Week 2. Receives: Drug: Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484 |
| Subutex | Active comparator | Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) during Weeks 2-4 with weekly access to take-home doses as of Week 2. Receives: Drug: Subutex, Buprenorphine Hydrochloride, SCH 28444 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Response rate was defined as the percentage of participants who did not receive a dose increase from the dose given at the first dosing date by Day 7 of a one-week, randomized, double-blind, double-dummy treatment transfer phase.
Measured: Assessed by Day 7 of double-blind, double-dummy treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startMar 2008
- Primary completionApr 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indivior Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605033
- Sponsor's protocol ID
- P04843
- Other IDs
- SWITCH
- Status last verified
- Sep 2016
- First submitted
- 17 Jan 2008
- Last updated
- 21 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects
- ClinicalTrials.gov ID
- NCT00605033
- Acronym / sponsor ID
- P04843
- Conditions
- Opiate Dependence, Drug Dependence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Indivior Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 30 Jan 2008 (estimated)
- Results
- Posted 30 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suboxone | Active comparator | Drug: Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) during Weeks 2-4 with weekly access to take-home doses as of Week 2. |
| Subutex | Active comparator | Drug: Subutex, Buprenorphine Hydrochloride, SCH 28444Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) during Weeks 2-4 with weekly access to take-home doses as of Week 2. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must be males or non-pregnant, non-lactating females.
- Subjects must be at least 15 years of age, of either sex, and any race.
- Subjects (and/or the parent or guardian for subjects under the age of legal consent or who otherwise are unable to provide independent consent) must demonstrate willingness to participate in the study and to adhere to dose and visit schedules.
- Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria(18) for opioid dependence.
- Subjects must have been receiving maintenance treatment with Subutex at doses ranging from 4 mg to the maximum dose permitted by country labeling requirements, but not to exceed 24 mg/day, for at least 1 month prior to screening.
Key exclusion criteria (8 listed)
- Subjects for whom treatment with either Subutex or Suboxone as required in the protocol would be inconsistent with national labeling.
- Subjects who are unwilling or unable to comply with the requirements of the protocol (eg, pending incarceration) or are in a situation or condition that, in the opinion of the investigator, may interfere with participation in the study.
- Subjects who are participating in any other clinical study in which medication(s) are being delivered.
- Subjects with known allergy or sensitivity to naloxone.
- Subjects who are on the staff, affiliated with, or a family member of the staff personnel directly involved with this study.
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 |
|---|---|---|
| Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484Suboxone sublingual tablet 4 mg/1 mg - 24 mg/6 mg, daily for 28 days | Drug | Suboxone |
| Subutex, Buprenorphine Hydrochloride, SCH 28444Subutex sublingual tablet 4-24 mg, daily for 28 days | Drug | Subutex |
Primary outcome
Response Rate
Time frame: Assessed by Day 7 of double-blind, double-dummy treatment period.
Response rate was defined as the percentage of participants who did not receive a dose increase from the dose given at the first dosing date by Day 7 of a one-week, randomized, double-blind, double-dummy treatment transfer phase.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484 and Subutex, Buprenorphine Hydrochloride, SCH 28444 in people with Opiate Dependence and Drug Dependence, run by Indivior Inc..
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 9 inclusion and 8 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 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 30 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Response Rate (time frame: Assessed by Day 7 of double-blind, double-dummy treatment period.). 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 21 Oct 2016; AzTrials last refreshed its copy on 1 Nov 2026.