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

Opioid Dependency Clinical Trial

— RIME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00955162
• Other study ID #: BU0902
• Status: Completed
• Phase: Phase 4
• First received: August 5, 2009
• Last updated: November 28, 2012
• Start date: August 2009
• Est. completion date: May 2011

Study information

• Verified date: January 2010
• Source: Indivior Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: May 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Opioid Dependency

Intervention

Drug:
• Buprenorphine (Subutex)
Sublingual tablet
• Buprenorphine/naloxone (Suboxone)
Sublingual tablet

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Indivior Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of study drug injections per week		1 week	No
Secondary	Addiction severity		3 months	No
Secondary	Withdrawal severity		1 month	No