DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Opioid Dependency

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

Phase: Phase 4

Status: Completed

Sponsored by: Reckitt Benckiser Pharmaceuticals Inc.

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

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.

Clinical Details

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

Eligibility

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).

Locations and Contacts

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

Additional Information

Starting date: August 2009
Last updated: November 28, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017