A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)

Study Overview
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Brief Summary
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Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone.

Official Title
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A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects

Conditions
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Drug Dependence, Opiate Dependence

Intervention / Treatment
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* Drug: Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484
* Drug: Subutex, Buprenorphine Hydrochloride, SCH 28444


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Suboxone<br>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. | Drug: Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484<br>* Suboxone sublingual tablet 4 mg/1 mg - 24 mg/6 mg, daily for 28 days<br>|
| Active Comparator: Subutex<br>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. | Drug: Subutex, Buprenorphine Hydrochloride, SCH 28444<br>* Subutex sublingual tablet 4-24 mg, daily for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Assessed by Day 7 of double-blind, double-dummy treatment period. |