A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users (P05042)(COMPLETED)
Condition: Opiate Dependence; Drug Dependence; Substance Dependence
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Intervention: Suboxone (SCH 000484); Subutex (SCH 028444)
Intervention description: 2 mg and 8 mg sublingual tablets, Contains Buprenorphine Hydrochloride and Naloxone. Daily dosage of 8 mg - 24 mg. Duration: 28 Days; 2 mg and 8 mg sublingual tablets, Contains Buprenorphine Hydrochloride. Daily dosage of 8 mg - 24 mg. Duration: 28 Days
Intervention MeSH terms: Buprenorphine, Naloxone Drug Combination; Buprenorphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 188.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the acceptability and safety of Suboxone in heroin
      users as a replacement therapy for opioid dependency by comparing the clinical response of
      participants who are inducted directly onto Suboxone with that of participants who are
      inducted first to Subutex and then transferred to Suboxone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be males or non-pregnant, non-lactating females.

          -  Participants must be at least 15 years of age, of either sex, and any race.

          -  Participants (and/or the parent or guardian for participants 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.

          -  Participants must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth
             Edition, Text Revision (DSM-IV-TR) criteria for opioid dependence.

          -  Participants must have a methadone- and buprenorphine-negative UDS result prior to
             randomization.

          -  Each participant must confirm that he or she is practicing adequate contraception.
             Female volunteers of childbearing potential (including women who are less than 1 year
             postmenopausal and women who will be sexually active during the study) must agree to
             use a medically accepted method of contraception or must be surgically sterilized
             prior to screening, while receiving protocol-specified medication, and for 30 days
             after stopping the medication. Women who have been postmenopausal for >=1 year (ie,
             women who have experienced 12 or more consecutive months of amenorrhea) will be
             exempted from the requirement to use contraception during the study. Acceptable
             methods of contraception include condoms (male and female) with or without a
             spermicidal agent, diaphragm or cervical cap with a spermicidal agent, medically
             prescribed intrauterine device, oral or injectable hormonal contraceptives, and
             surgical sterilization (eg, hysterectomy or tubal ligation).

          -  Female participants of childbearing potential must have a negative urine beta-human
             chorionic gonadotropin (beta-hCG) test prior to enrollment in the study

        Exclusion Criteria:

          -  Participants for whom treatment with either Subutex or Suboxone as required in the
             protocol would be inconsistent with national labeling.

          -  Participants 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.

          -  Participants who are participating in any other clinical study in which medication(s)
             are being delivered.

          -  Participants with known allergy or sensitivity to buprenorphine or naloxone.

          -  Participants who are on the staff, affiliated with, or a family member of the staff
             personnel directly involved with this study.

          -  Participants with serious untreated Axis I DSM-IV-TR psychiatric co-morbidity (eg,
             those who are actively suicidal or homicidal, have untreated schizophrenia, etc).
             Polysubstance abuse or dependence will not exclude participants except in the case of
             unauthorized and significant benzodiazepine use requiring medical detoxification or
             alcohol dependence requiring medical detoxification.

          -  HIV-positive participants with clinical acquired immunodeficiency syndrome (AIDS).

          -  Methadone or buprenorphine maintenance or detoxification within 30 days of enrollment.