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

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ClinicalTrials.gov Identifier: NCT00955162
Recruitment Status : Completed
First Posted : August 7, 2009
Last Update Posted : November 30, 2012
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Opioid Dependency Drug: Buprenorphine (Subutex) Drug: Buprenorphine/naloxone (Suboxone) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Randomised, Open-label, Active-controlled Trial of the Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France
Study Start Date : August 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Subutex Drug: Buprenorphine (Subutex)
Sublingual tablet
Other Name: Subutex
Experimental: Suboxone Drug: Buprenorphine/naloxone (Suboxone)
Sublingual tablet
Other Name: Suboxone



Primary Outcome Measures :
  1. number of study drug injections per week [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Addiction severity [ Time Frame: 3 months ]
  2. Withdrawal severity [ Time Frame: 1 month ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female opioid-dependent outpatient aged 18 years or older,
  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:

  1. Pregnancy or breast-feeding,
  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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955162


Locations
France
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
Nimes, France
Hôpital Caremeau
Nimes, 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
Sponsors and Collaborators
Indivior Inc.
Investigators
Principal Investigator: Didier TOUZEAU, MD Hôpital Paul Guiraud, Bagneux

Responsible Party: Indivior Inc.
ClinicalTrials.gov Identifier: NCT00955162     History of Changes
Other Study ID Numbers: BU0902
First Posted: August 7, 2009    Key Record Dates
Last Update Posted: November 30, 2012
Last Verified: January 2010

Keywords provided by Indivior Inc.:
Substance Abuse, Intravenous
Buprenorphine

Additional relevant MeSH terms:
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists