Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex® (Study P05094)(COMPLETED)
Condition: Opiate-related Disorders; Opiate Dependence; Drug Abuse
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Intervention: buprenorphine; buprenorphine/naloxone
Intervention description: 2 mg buprenorphine and 8 mg buprenorphine tablets at doses from 2 to 16 mg buprenorphine daily for first two days of study; 2/0.5 mg buprenorphine/naloxone and 8/2 mg buprenorphine/naloxone tablets at doses from 2/0.5 mg buprenorphine/naloxone to 16/4 mg buprenorphine/naloxone daily for last 3 days of study
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Suboxone; Subutex; Buprenorphine; Naloxone

Summary:

      This study is designed to determine if opioid dependent subjects who are already receiving
      Subutex® prefer the Suboxone® tablet over the Subutex® tablet after switching from Subutex®
      to Suboxone®. Subjects who are selected to participate in this study will continue their
      prescribed dose of Subutex® (buprenorphine 2 to 16 mg daily) for the first two days of the
      study (Day 1 and Day 2) then switch to and receive an equivalent dose of Suboxone®
      (buprenorphine 2 to 16 mg daily) for the last 3 days of the study (Day 3, Day 4 and Day 5).
      The Day 5 Visit will be the subject's last study visit. Upon completing the study, subjects
      will continue their pre-study prescribed dosage of Subutex®.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must demonstrate their willingness to participate in the study and comply with
             its procedures by signing a written informed consent.

          -  Subject must be at least (>=) 18 years of age, of either sex.

          -  Subject treated for opioid dependence with Subutex® with a stable daily dose between 2
             mg and 16 mg daily, for at least 6 months.

          -  Subject who do not inject/misuse their treatment with Subutex®.

          -  Subject must be free of illicit opiate drug use as assessed by urine test performed
             prior to inclusion.

          -  Subject must understand and be able to adhere to the dosing and visit schedules, and
             agree to report concomitant medications / products and adverse events to the
             investigator or designee.

          -  Women of childbearing potential (includes women who are less than one year
             postmenopausal and women who become sexually active) must be using or agree to use an
             acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed
             IUD, condom in combination with spermicide) or be surgically sterile (e.g.,
             hysterectomy or tubal ligation).

          -  Women of childbearing potential should be counseled in the appropriate use of birth
             control while in this study. Women who are not currently sexually active must agree
             and consent to use one of the above-mentioned methods should they become sexually
             active while participating in the study. Women of childbearing potential must have a
             urine pregnancy test with negative result within 2 weeks prior to inclusion (as
             performed under control of the investigator or designee).

        Exclusion Criteria:

          -  Subject not eligible for treatment with Subutex® or Suboxone® according to the legal
             drug attachments.

          -  Subject refusing to take the daily dose of the study medication under control in the
             center.

          -  Subject unable to complete the evaluations.

          -  Women who are pregnant or nursing.

          -  Subject with a history of hypersensitivity to buprenorphine hydrochloride or naloxone
             hydrochloride dihydrate or any excipient of Subutex® or Suboxone®.

          -  Subject with a current evidence of alcohol abuse.

          -  Subject with severe respiratory dysfunction, severe hepatic dysfunction, acute alcohol
             intoxication or delirium tremens .

          -  Subject with rare hereditary problems of galactose intolerance, the Lapp lactase
             deficiency or glucosegalactose malabsorption.

          -  Initiation or increase in the dose, within the past 7 days or scheduled during the
             study, of a treatment with:

               -  benzodiazepines,

               -  other depressants of the central nervous system: other morphine derivatives
                  (analgesics, antitussives), certain antidepressive agents, sedative H1
                  antihistamines, barbiturates, benzodiazepines, anxiolytics other than
                  benzodiazepines, neuroleptics, clonidine and clonidine-like agents and monoamine
                  oxidase [MAO] inhibitors,

               -  CYP3A4 inhibitors,

               -  CYP3A4 inducers.

          -  Subjects who have any current evidence of clinically significant hematopoietic,
             metabolic, cardiovascular, immunologic, neurologic, hematological, gastrointestinal,
             hepatic, renal, psychiatric, cerebrovascular, or respiratory disease, or any other
             disorder which, in the judgment of the investigator, may interfere with the study
             evaluations or affect subject safety.

          -  Subjects who have used any investigational product within 30 days prior to enrollment.

          -  Subjects participating in another trial at the same time.

          -  Subject who intend to donate blood during the study or within 3 months after study
             completion.

          -  Subjects in the exclusion period of the "Fichier National des Personnes qui se Prêtent
             à des Recherches Biomédicales" (National Index of Persons Participating in Biomedical
             Researches, or National Index of Volunteers).