Study of Two Formulations of Buprenorphine HCl in Opioid-dependent Subjects on Buprenorphine Maintenance Therapy (Study P04451) (COMPLETED)
Condition: Opioid Dependency
Intervention: Buprenorphine hydrochloride marketed sublingual tablet (Subutex); Buprenorphine hydrochloride fast dissolving tablet (FDT)
Intervention description: 8 mg or 16 mg daily, sublingual route on Days 1 and 2; 8 mg or 16 mg daily, sublingual route on Days 3, 4, and 5
Intervention MeSH terms: Buprenorphine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Buprenorphine tablet; Fast dissolving tablet; Opioid dependant patients

Summary:

      This is a multi-center, open-label, preference study of two sublingual formulations of
      buprenorphine HCl, in opioid-dependent patients on buprenorphine maintenance therapy.

      The objectives of this study are to evaluate the overall preference between two buprenorphine
      sublingual formulations, after a switch from the marketed tablet (Subutex®) to the new fast
      dissolving tablet (FDT), in opioid-dependent patients with buprenorphine 8 mg or 16 mg daily
      maintenance therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must demonstrate their willingness to participate in the study and comply
             with its procedures by signing a written informed consent.

          -  Patients must be at least (≥) 18 years of age, of either sex.

          -  Patients treated for opioid dependence with Subutex®, with a stable dosage of 8 mg or
             16 mg daily, and respecting the legal drug attachments.

          -  Patients 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:

          -  Patients refusing to take the daily dose of the study medication under control in the
             center.

          -  Patients unable to complete the evaluations.

          -  Women who are pregnant or nursing.

          -  Patients with a history of hypersensitivity to buprenorphine hydrochloride or any
             excipient of one of its formulations.

          -  Patients with a current evidence of alcohol abuse.

          -  Patients with severe respiratory dysfunction, severe hepatic dysfunction, acute
             alcohol intoxication or delirium tremens.

          -  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,

               -  monoamine oxydase [MAO] inhibitors.

          -  Patients 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 patient safety.

          -  Patients who have used any investigational product within 30 days prior to enrollment.

          -  Patients participating in another trial at the same time.

          -  Patients intending to donate blood during the study or within 3 months after study
             completion.

          -  Patients in the exclusion period of the "Fichier National des personnes qui se prêtent
             à des recherches biomédicales sans bénéfice individuel direct" (National Index of
             persons participating in biomedical researches without direct individual benefit, or
             National Index of volunteers).

          -  Patients without Social Security number, or whose maximum annual compensation (3,800
             €) has been exceeded.