Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France ("RIME")
NCT ID: NCT00955162
Last Updated: 2012-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
270 participants
INTERVENTIONAL
2009-08-31
2011-05-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Subutex
Buprenorphine (Subutex)
Sublingual tablet
Suboxone
Buprenorphine/naloxone (Suboxone)
Sublingual tablet
Interventions
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Buprenorphine (Subutex)
Sublingual tablet
Buprenorphine/naloxone (Suboxone)
Sublingual tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Women of childbearing potential must have a negative urine pregnancy test result at the Inclusion Visit (test under supervision of the investigator or designee),
3. 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),
4. On buprenorphine (Subutex® or generic buprenorphine) maintenance therapy at a minimum daily dose of 2 mg for at least 3 months prior to inclusion,
5. Declaring buprenorphine intravenous misuse at least four times/week and showing needle marks,
6. Willing to stop or reduce buprenorphine intravenous misuse,
7. Having received oral and written information about the trial, and provided written informed consent prior to admission to this trial.
Exclusion Criteria
2. Contraindication or history of hypersensitivity to buprenorphine, naloxone or to any excipient of Suboxone® or Subutex®,
3. Any medical or psychiatric condition which in the opinion of the investigator would make participation difficult or unsafe,
4. Participating in another trial,
5. 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).
18 Years
ALL
No
Sponsors
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Indivior Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Didier TOUZEAU, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Paul Guiraud, Bagneux
Locations
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Csst Antibes
Antibes, , France
Hopital Paul Guiraud
Bagneux, , France
Cssa Bizia
Bayonne, , 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
CSST NAUTILIA (Ex Alinea)
Le Havre, , France
CSST Le Cèdre Bleu
Lille, , France
Centre Hospitalier Esquirol - Intersecteur, Regional Soins en Addictologie
Limoges, , France
Centre Baudelaire
Metz, , France
Csst de Montauban
Montauban, , France
CSST Centre Hospitalier
Nice, , France
CSST Logos
Nîmes, , France
Hôpital Caremeau
Nîmes, , France
Csst Espace Murger
Paris, , France
Hôpital Saint Anne
Paris, , France
Centre L'Envol (Csst)
Rennes, , France
Centre Baudelaire
Thionville, , France
Hopital Joseph Ducuing
Toulouse, , France
CSST Centre Port Bretagne CH Charles Perrens
Tours, , France
Countries
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Other Identifiers
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BU0902
Identifier Type: -
Identifier Source: org_study_id