Back to resultsA Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)
Primary Purpose
Opiate Dependence, Drug Dependence
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484
Subutex, Buprenorphine Hydrochloride, SCH 28444
Sponsored by
About this trial
This is an interventional treatment trial for Opiate Dependence
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Suboxone
Subutex
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00605033
Brief Title
A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)
Official Title
A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indivior Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence, Drug Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
241 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Suboxone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Subutex
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484
Intervention Description
Suboxone sublingual tablet 4 mg/1 mg - 24 mg/6 mg, daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Subutex, Buprenorphine Hydrochloride, SCH 28444
Intervention Description
Subutex sublingual tablet 4-24 mg, daily for 28 days
Primary Outcome Measure Information:
Title
Response Rate
Description
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.
Time Frame
Assessed by Day 7 of double-blind, double-dummy treatment period.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Learn more about this trial
A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)
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