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

Condition(s) targeted: Opioid Dependency

Intervention: Buprenorphine (Subutex) (Drug); Buprenorphine/naloxone (Suboxone) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Reckitt Benckiser Pharmaceuticals, Inc

Official(s) and/or principal investigator(s):
Didier TOUZEAU, MD, Principal Investigator, Affiliation: Hôpital Paul Guiraud, Bagneux

Overall contact:
Didier Touzeau, Phone: 01 45 36 11 20

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.

Official title: A Multicentre, Randomised, Open-label, Active-controlled Trial of the Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: number of study drug injections per week

Secondary outcome:

Addiction severity

Withdrawal severity

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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).

Didier Touzeau, Phone: 01 45 36 11 20

Csst Antibes, Antibes, France; Recruiting
Pierre Airaudi, Phone: 04 93 33 26 82
Pierre Airaudi, Principal Investigator

Hopital Paul Guiraud, Bagneux, France; Recruiting
Didier Touzeau, Phone: 01 45 36 11 20
Didier Touzeau, Principal Investigator

Cssa Bizia, Bayonne, France; Recruiting
Jean-Pierre Daulouede, Phone: 05 59 44 31 00
Jean-Pierre Daulouede, Principal Investigator

Centre Carreire , CH Charles Perrens, Bordeaux, France; Recruiting
Marc Auriacombe, Phone: 05 56 56 67 02
Marc Auriacombe, Principal Investigator

CHU de Clermont-Ferrand, Centre Méthadone, Clermont-Ferrand, France; Recruiting
Pascal Courty, Phone: 04 73 75 21 32
Pascal Courty, Principal Investigator

Service d'addictologie, Hopital de Dole, Dole, France; Recruiting
DANIEL BONNAFFOUX, Phone: 03 84 82 83 61
DANIEL BONNAFFOUX, Principal Investigator

CSST NAUTILIA (Ex Alinea), Le Havre, France; Recruiting
Didier Michel, Phone: 02 35 19 32 43
Didier Michel, Principal Investigator

CSST Le Cèdre Bleu, Lille, France; Recruiting
Jean-Michel Piquet, Phone: 03 20 08 16 61
Jean-Michel Piquet, Principal Investigator

Centre Hospitalier Esquirol - Intersecteur, Regional Soins en Addictologie, Limoges, France; Recruiting
Pierre Villeger, Phone: 05 55 43 12 56
Pierre Villeger, Principal Investigator

Centre Baudelaire, Metz, France; Recruiting
Claude Baudelaire, Phone: 03 87 76 97 32
Claude Baudelaire, Principal Investigator

Csst de Montauban, Montauban, France; Recruiting
Jerome Heysch de la Borde, Phone: 05 63 92 82 82
Jerome Heysch de la Borde, Principal Investigator

CSST Centre Hospitalier, Nice, France; Recruiting
Colette Gerbaud, Phone: 04 92 03 37 19
Colette Gerbaud, Principal Investigator

Hôpital Caremeau, Nimes, France; Recruiting
Yves Caer, Phone: 04 66 68 33 01
Yves Caer, Principal Investigator

CSST Logos, Nimes, France; Recruiting
Sylvie Allheilig, Phone: 04 66 76 93 52
Sylvie Allheilig, Principal Investigator

Csst Espace Murger, Paris, France; Recruiting
Florence Vorspan, Phone: 01 40 05 42 14
Florence Vorspan, Principal Investigator

Hôpital Saint Anne, Paris, France; Recruiting
XAVIER LAQUEILLE, Phone: 01 45 65 80 00
XAVIER LAQUEILLE, Principal Investigator

Centre L'Envol (Csst), Rennes, France; Recruiting
Gael Lagadec, Phone: 02 99 33 39 20
Gael Lagadec, Principal Investigator

Centre Baudelaire, Thionville, France; Recruiting
Olivier Pouclet, Phone: 03 82 59 29 73
Olivier Pouclet, Principal Investigator

Hopital Joseph Ducuing, Toulouse, France; Recruiting
Marie-Josee Ferro, Phone: 05 61 77 34 48
Marie-Josee Ferro, Principal Investigator

CSST Centre Port Bretagne CH Charles Perrens, Tours, France; Recruiting
Jerome Bachellier, Phone: 02 47 47 91 91
Jerome Bachellier, Principal Investigator

Starting date: August 2009
Last updated: January 14, 2010