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.
Conditions
Interventions
Trade Name: Suboxone
Pharmaceutical Form: Sublingual tablet
Trade Name: Subutex
Pharmaceutical Form: Sublingual tablet
Sponsors
Schering-Plough
Eligibility
Sex/Gender
All
Inclusion 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 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
Exclusion criteria
Exclusion criteria: – 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: o benzodiazepines, o 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, o monoamine oxydase [MAO] inhibitors, o CYP3A4 inhibitors, o 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. – 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the overall preference for a buprenorphine-based maintenance therapy after a switch from buprenorphine alone (Subutex) to the buprenorphine/naloxone combination (Suboxone) in opioid-dependent patients treated with Subutex 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, 12 mg, 14 mg, or 16 mg daily. The overall preference will be evaluated from the patients' overall satisfaction level under each treatment, as assessed using visual analogic scales (VAS). ;Secondary Objective: –To evaluate the preference of these patients for one the two buprenorphine-based maintenance therapies in regards to,the tablet taste, the tablet size, the sublingual retention time, the well being over 24 hours, their wish to continue with Suboxone®. These previous items will be measured by visual analogic scale (VAS). –To compare both buprenorphine-based maintenance therapies in these patients in regards to, the sublingual retention time and the mode of tablet intake (together / successively). –To further, this study should also confirm the safety profile of the new combination of buprenorphine / naloxone. ;Primary end point(s): The overall satisfaction (VAS) on Day 1 to 5 for each treatment will be presented by an AUC. The comparison inter-treatment will be performed by student test. | — |
Countries
France
Outcome results
None listed