• Percentage of subjects with a drug-free test for opioids and non-opioid substances will be analyzed using the 2 sample t-test. [ Time Frame: week 1, day 15, 22 and day 28 ] [ Designated as safety issue: No ]
• SUI will be analyzed using a mixed model for repeated measures. This model will include treatment, visit, and treatment-by-visit as the fixed effects. The two-sided 95% confidence interval for the treatment difference will be presented [ Time Frame: Day 1 to day 8 daily, day 15, day 22 and day 28 ] [ Designated as safety issue: No ]
• SOWS will be analyzed using the same methods as those for the SUI analyses. [ Time Frame: Day 1 to day 8 daily, day 15, day 22 and day 28 ] [ Designated as safety issue: No ]
• Change from baseline of ASI-Lite will be analyzed using the 2-sample t-test [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]
• Compliance rate will be analyzed using the 2-sample t-test [ Time Frame: week 1, week 2, week 3 and week 4 ] [ Designated as safety issue: No ]
• Treatment retention (ie, subjects who attend the study setting according to the study schedule) will be analyzed using the 2-sample t-test. [ Time Frame: week 1, week 2, week 3 and week 4. ] [ Designated as safety issue: No ]
• Measure: Time to dose increase, by the number of days until a dose increase was received via Cox's proportional hazards model. [ Time Frame: week 1 and week 4 ] [ Designated as safety issue: No ]

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

• Opiate Dependence
• Drug Dependence

• Drug: Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484
  Suboxone sublingual tablet 4-24 mg, daily for 28 days
• Drug: Subutex, Buprenorphine Hydrochloride, SCH 28444
  Subutex sublingual tablet 4-24 mg, daily for 28 days

• Suboxone Active ( plus Subutex Placebo): Active Comparator
  None
  Intervention: Drug: Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484
• Subutex Active (plus Suboxone Placebo): Active Comparator
  None
  Intervention: Drug: Subutex, Buprenorphine Hydrochloride, SCH 28444

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 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.
• HIV-positive subjects with clinical acquired immunodeficiency syndrome (AIDS).
• Subjects treated with generic buprenorphine.