A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)
Condition: Opiate Dependence; Drug Dependence
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Intervention: Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484; Subutex, Buprenorphine Hydrochloride, SCH 28444
Intervention description: Suboxone sublingual tablet 4 mg/1 mg - 24 mg/6 mg, daily for 28 days; Subutex sublingual tablet 4-24 mg, daily for 28 days
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 241.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No

Summary:

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

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.