Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France ("RIME")

Inclusion criteria

• Male or female opioid-dependent outpatient aged 18 years or older,
• Women of childbearing potential must have a negative urine pregnancy test result at the Inclusion Visit (test under supervision of the investigator or designee),
• Women of childbearing potential must use an effective birth control method. Women of non-childbearing potential must be postmenopausal or must be surgically sterile (hysterectomy and/or bilateral oophorectomy),
• On buprenorphine (Subutex® or generic buprenorphine) maintenance therapy at a minimum daily dose of 2 mg for at least 3 months prior to inclusion,
• Declaring buprenorphine intravenous misuse at least four times/week and showing needle marks,
• Willing to stop or reduce buprenorphine intravenous misuse,
• Having received oral and written information about the trial, and provided written informed consent prior to admission to this trial.

Exclusion criteria

• Pregnancy or breast-feeding,
• Contraindication or history of hypersensitivity to buprenorphine, naloxone or to any excipient of Suboxone® or Subutex®,
• Any medical or psychiatric condition which in the opinion of the investigator would make participation difficult or unsafe,
• Participating in another trial,
• 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).