Full Text View
Tabular View
No Study Results Posted
Related Studies
Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France ("RIME")
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Reckitt Benckiser Pharmaceuticals, Inc.   Recruitment status was  Recruiting

First Received on August 5, 2009.   Last Updated on January 14, 2010   History of Changes
Sponsor: Reckitt Benckiser Pharmaceuticals, Inc
Collaborator: ClinSearch
Information provided by: Reckitt Benckiser Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00955162
  Purpose

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 Intervention Phase
Opioid Dependency
Drug: Buprenorphine (Subutex)
Drug: Buprenorphine/naloxone (Suboxone)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Reckitt Benckiser Pharmaceuticals, Inc:

Primary Outcome Measures:
  • number of study drug injections per week [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Addiction severity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Withdrawal severity [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: August 2009
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Subutex Drug: Buprenorphine (Subutex)
Sublingual tablet
Other Name: Subutex
Experimental: Suboxone Drug: Buprenorphine/naloxone (Suboxone)
Sublingual tablet
Other Name: Suboxone

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955162

Contacts
Contact: Didier Touzeau 01 45 36 11 20
Contact: Cecile Train cecile.train@clinsearch.fr

Locations
France
Csst Antibes Recruiting
Antibes, France
Contact: Pierre Airaudi     04 93 33 26 82        
Principal Investigator: Pierre Airaudi            
Hopital Paul Guiraud Recruiting
Bagneux, France
Contact: Didier Touzeau     01 45 36 11 20        
Principal Investigator: Didier Touzeau            
Cssa Bizia Recruiting
Bayonne, France
Contact: Jean-Pierre Daulouede     05 59 44 31 00        
Principal Investigator: Jean-Pierre Daulouede            
Centre Carreire , CH Charles Perrens Recruiting
Bordeaux, France
Contact: Marc Auriacombe     05 56 56 67 02        
Principal Investigator: Marc Auriacombe            
CHU de Clermont-Ferrand, Centre Méthadone Recruiting
Clermont-Ferrand, France
Contact: Pascal Courty     04 73 75 21 32        
Principal Investigator: Pascal Courty            
Service d'addictologie, Hopital de Dole Recruiting
Dole, France
Contact: DANIEL BONNAFFOUX     03 84 82 83 61        
Principal Investigator: DANIEL BONNAFFOUX            
CSST NAUTILIA (Ex Alinea) Recruiting
Le Havre, France
Contact: Didier Michel     02 35 19 32 43        
Principal Investigator: Didier Michel            
CSST Le Cèdre Bleu Recruiting
Lille, France
Contact: Jean-Michel Piquet     03 20 08 16 61        
Principal Investigator: Jean-Michel Piquet            
Centre Hospitalier Esquirol - Intersecteur, Regional Soins en Addictologie Recruiting
Limoges, France
Contact: Pierre Villeger     05 55 43 12 56        
Principal Investigator: Pierre Villeger            
Centre Baudelaire Recruiting
Metz, France
Contact: Claude Baudelaire     03 87 76 97 32        
Principal Investigator: Claude Baudelaire            
Csst de Montauban Recruiting
Montauban, France
Contact: Jerome Heysch de la Borde     05 63 92 82 82        
Principal Investigator: Jerome Heysch de la Borde            
CSST Centre Hospitalier Recruiting
Nice, France
Contact: Colette Gerbaud     04 92 03 37 19        
Principal Investigator: Colette Gerbaud            
Hôpital Caremeau Recruiting
Nimes, France
Contact: Yves Caer     04 66 68 33 01        
Principal Investigator: Yves Caer            
CSST Logos Recruiting
Nimes, France
Contact: Sylvie Allheilig     04 66 76 93 52        
Principal Investigator: Sylvie Allheilig            
Csst Espace Murger Recruiting
Paris, France
Contact: Florence Vorspan     01 40 05 42 14        
Principal Investigator: Florence Vorspan            
Hôpital Saint Anne Recruiting
Paris, France
Contact: XAVIER LAQUEILLE     01 45 65 80 00        
Principal Investigator: XAVIER LAQUEILLE            
Centre L'Envol (Csst) Recruiting
Rennes, France
Contact: Gael Lagadec     02 99 33 39 20        
Principal Investigator: Gael Lagadec            
Centre Baudelaire Recruiting
Thionville, France
Contact: Olivier Pouclet     03 82 59 29 73        
Principal Investigator: Olivier Pouclet            
Hopital Joseph Ducuing Recruiting
Toulouse, France
Contact: Marie-Josee Ferro     05 61 77 34 48        
Principal Investigator: Marie-Josee Ferro            
CSST Centre Port Bretagne CH Charles Perrens Recruiting
Tours, France
Contact: Jerome Bachellier     02 47 47 91 91        
Principal Investigator: Jerome Bachellier            
Sponsors and Collaborators
Reckitt Benckiser Pharmaceuticals, Inc
ClinSearch
Investigators
Principal Investigator: Didier TOUZEAU, MD Hôpital Paul Guiraud, Bagneux
  More Information

No publications provided

Responsible Party: David Crossley, Clinical Project Manager, Reckitt Benckiser Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00955162     History of Changes
Other Study ID Numbers: BU0902
Study First Received: August 5, 2009
Last Updated: January 14, 2010
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by Reckitt Benckiser Pharmaceuticals, Inc:
Substance Abuse, Intravenous
Buprenorphine

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

ClinicalTrials.gov processed this record on May 23, 2012