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

November 28, 2012 updated by: Indivior Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Antibes, France
        • Csst Antibes
      • Bagneux, France
        • Hopital Paul Guiraud
      • Bayonne, France
        • Cssa Bizia
      • Bordeaux, France
        • Centre Carreire , CH Charles Perrens
      • Clermont-Ferrand, France
        • CHU de Clermont-Ferrand, Centre Méthadone
      • Dole, France
        • Service d'addictologie, Hopital de Dole
      • Le Havre, France
        • CSST NAUTILIA (Ex Alinea)
      • Lille, France
        • CSST Le Cèdre Bleu
      • Limoges, France
        • Centre Hospitalier Esquirol - Intersecteur, Regional Soins en Addictologie
      • Metz, France
        • Centre Baudelaire
      • Montauban, France
        • Csst de Montauban
      • Nice, France
        • CSST Centre Hospitalier
      • Nimes, France
        • CSST Logos
      • Nimes, France
        • Hopital Caremeau
      • Paris, France
        • Hopital Saint Anne
      • Paris, France
        • Csst Espace Murger
      • Rennes, France
        • Centre L'Envol (Csst)
      • Thionville, France
        • Centre Baudelaire
      • Toulouse, France
        • Hôpital Joseph Ducuing
      • Tours, France
        • CSST Centre Port Bretagne CH Charles Perrens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Subutex
Drug: Buprenorphine (Subutex)
Sublingual tablet
Other Names:
  • Subutex
Experimental: Suboxone
Drug: Buprenorphine/naloxone (Suboxone)
Sublingual tablet
Other Names:
  • Suboxone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of study drug injections per week
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Addiction severity
Time Frame: 3 months
3 months
Withdrawal severity
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indivior Inc.

Investigators

  • Principal Investigator: Didier TOUZEAU, MD, Hôpital Paul Guiraud, Bagneux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

August 5, 2009

First Submitted That Met QC Criteria

August 6, 2009

First Posted (Estimate)

August 7, 2009

Study Record Updates

Last Update Posted (Estimate)

November 30, 2012

Last Update Submitted That Met QC Criteria

November 28, 2012

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BU0902

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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