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 (buprenorphin 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.
Inclusion Criteria:
- Patient must demonstrate their willingness to participate in the study and comply with
its procedures by signing a written informed consent.
- Patient must be at least (>=) 18 years of age, of either sex.
- Patient treated for opioid dependence with Subutex® with a stable daily dose between 2
mg and 16 mg daily, for at least 6 months.
- Patient who do not inject/misuse their treatment with Subutex®.
- Patient must be free of illicit opiate drug use as assessed by urine test performed
prior to inclusion.
- Patient 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:
- Patient not eligible for treatment with Subutex® or Suboxone® according to the legal
drug attachments.
- Patient refusing to take the daily dose of the study medication under control in the
center.
- Patient unable to complete the evaluations.
- Women who are pregnant or nursing.
- Patient with a history of hypersensitivity to buprenorphine hydrochloride or naloxone
hydrochloride dihydrate or any excipient of Subutex® or Suboxone®.
- Patient with a current evidence of alcohol abuse.
- Patient with severe respiratory dysfunction, severe hepatic dysfunction, acute alcohol
intoxication or delirium tremens .
- Patient 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
oxydase [MAO] inhibitors,
- CYP3A4 inhibitors,
- CYP3A4 inducers.
- 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.
- Patient who intend 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" (National Index of Persons Participating in Biomedical
Researches, or National Index of Volunteers).
- Patients without Social Security number, or whose maximum annual compensation (4,500
€) has been exceeded.
