Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France ("RIME")
- Conditions
- Opioid Dependency
- Interventions
- Drug: Buprenorphine/naloxone (Suboxone)
- Registration Number
- NCT00955162
- Lead Sponsor
- Indivior Inc.
- 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 Suboxone than with Subutex based primarily on patient diaries.
Patients randomized to Suboxone may continue to receive the product for a further 9 months at their request and will be monitored at 3 month intervals.
Patients will receive a payment for the inconvenience of keeping a daily diary and to cover their travel expenses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Subutex Buprenorphine (Subutex) - Suboxone Buprenorphine/naloxone (Suboxone) -
- Primary Outcome Measures
Name Time Method number of study drug injections per week 1 week
- Secondary Outcome Measures
Name Time Method Addiction severity 3 months Withdrawal severity 1 month
Trial Locations
- Locations (19)
Csst Antibes
🇫🇷Antibes, France
Hopital Paul Guiraud
🇫🇷Bagneux, France
Centre Carreire , CH Charles Perrens
🇫🇷Bordeaux, France
CHU de Clermont-Ferrand, Centre Méthadone
🇫🇷Clermont-Ferrand, France
Service d'addictologie, Hopital de Dole
🇫🇷Dole, France
Cssa Bizia
🇫🇷Bayonne, France
CSST Le Cèdre Bleu
🇫🇷Lille, France
Centre Baudelaire
🇫🇷Thionville, France
CSST NAUTILIA (Ex Alinea)
🇫🇷Le Havre, France
Centre Hospitalier Esquirol - Intersecteur, Regional Soins en Addictologie
🇫🇷Limoges, France
Csst de Montauban
🇫🇷Montauban, France
CSST Centre Hospitalier
🇫🇷Nice, France
CSST Logos
🇫🇷Nimes, France
Hôpital Caremeau
🇫🇷Nimes, France
Hôpital Saint Anne
🇫🇷Paris, France
Csst Espace Murger
🇫🇷Paris, France
Hopital Joseph Ducuing
🇫🇷Toulouse, France
Centre L'Envol (Csst)
🇫🇷Rennes, France
CSST Centre Port Bretagne CH Charles Perrens
🇫🇷Tours, France