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CompletedNCT00955162RIMEUpdated Nov 30, 2012

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

A Phase 4 interventional study of Buprenorphine (Subutex) and Buprenorphine/naloxone (Suboxone) in Opioid Dependency, sponsored by Indivior Inc.. Completed at 20 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-30.

Sponsored by Indivior Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
270
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Opioid Dependency

Keywords

  • Substance Abuse, Intravenous
  • Buprenorphine
03

In context

Lead sponsor

Indivior Inc. is the lead sponsor of 51 studies on the registry; none are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
270 participants (actual)

Study arms

  • Active comparator
    Subutex

    Drug: Buprenorphine (Subutex)

  • Experimental
    Suboxone

    Drug: Buprenorphine/naloxone (Suboxone)

Interventions

  • DrugBuprenorphine (Subutex)

    Sublingual tablet

    Also known as: Subutex

  • DrugBuprenorphine/naloxone (Suboxone)

    Sublingual tablet

    Also known as: Suboxone

06

What researchers measure

Primary outcomes

  1. number of study drug injections per week

    Time frame: 1 week

Secondary outcomes

  1. Addiction severity

    Time frame: 3 months

  2. Withdrawal severity

    Time frame: 1 month

07

Study locations

20 sites
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00955162
Lead sponsor
Indivior Inc.
Responsible party
Sponsor
First posted
Aug 7, 2009
Start date
Aug 2009
Primary completion
May 2010
Completion
May 2011
Last update
Nov 30, 2012

Study contacts

Didier TOUZEAU, MD
principal investigator · Hôpital Paul Guiraud, Bagneux

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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