Evaluation of preference for a buprenorphine-based maintenance therapy, after a switch from buprenorphine alone (Subutex®) to the buprenorphine/naloxone combination (Suboxone®), in opioid-dependent patients with buprenorphine maintenance therapy
- Conditions
- For both compounds, substitution treatment for opiod drug dependence, adult subjects with a diagnosis of major heroin dependence. Only for Suboxone, the intention of naloxone is to deter the intravenous misuse.
- Registration Number
- EUCTR2006-006686-17-FR
- Lead Sponsor
- Schering-Plough
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
–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 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.
–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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
–Patient not eligible for treatment with Subutex® or Suboxone® according to the legal drug attachments (appendices 2 and 3).
–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 naloxone hydrochloride dihydrate or any excipient of Subutex® or Suboxone®.
–Patients with a current evidence of alcohol abuse.
–Patients with severe respiratory dysfunction, severe hepatic dysfunction, acute alcohol intoxication or delirium tremens (as indicated in the legal attachments of Subutex®, appendix 2 and in the legal attachments of Suboxone®, appendix 3).
–Patients 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:
obenzodiazepines,
oother 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,
omonoamine oxydase [MAO] inhibitors,
oCYP3A4 inhibitors,
oCYP3A4 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.
–Patients who intent 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method