Status:
COMPLETED
Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France ("RIME")
Lead Sponsor:
Indivior Inc.
Conditions:
Opioid Dependency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Patients who admit to using buprenorphine by the intravenous route will be randomized to either Subutex or Suboxone and be followed up for 3 months to determine if there is less injection with Suboxon...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00955162
Start Date
August 1 2009
End Date
May 1 2011
Last Update
November 30 2012
Active Locations (20)
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1
Csst Antibes
Antibes, France
2
Hopital Paul Guiraud
Bagneux, France
3
Cssa Bizia
Bayonne, France
4
Centre Carreire , CH Charles Perrens
Bordeaux, France