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| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Didier Touzeau | 01 45 36 11 20 | |
| Contact: Cecile Train | cecile.train@clinsearch.fr |
| 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 | |
| Principal Investigator: | Didier TOUZEAU, MD | Hôpital Paul Guiraud, Bagneux |
More Information
| 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 |
|
Substance Abuse, Intravenous Buprenorphine |
|
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 |