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

NCT00955162 | Completed Phase 4

• 1 other identifier: BU0902
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Opioid Dependency

Keywords

Substance Abuse, Intravenous; Buprenorphine

Outcome Measures

Primary Outcomes (1)

• number of study drug injections per week

  1 week

Secondary Outcomes (2)

• Addiction severity

  3 months

• Withdrawal severity

  1 month

Study Arms (2)

Subutex

ACTIVE COMPARATOR

Drug: Buprenorphine (Subutex)

Suboxone

EXPERIMENTAL

Drug: Buprenorphine/naloxone (Suboxone)

Interventions

Buprenorphine (Subutex) DRUG

Sublingual tablet

Also known as: Subutex

Subutex

Buprenorphine/naloxone (Suboxone) DRUG

Sublingual tablet

Also known as: Suboxone

Suboxone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female opioid-dependent outpatient aged 18 years or older,
• 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),
• Declaring buprenorphine intravenous misuse at least four times/week and showing needle marks,
• Willing to stop or reduce buprenorphine intravenous misuse,
• Having received oral and written information about the trial, and provided written informed consent prior to admission to this trial.

You may not qualify if:

• Pregnancy or breast-feeding,
• Contraindication or history of hypersensitivity to buprenorphine, naloxone or to any excipient of Suboxone® or Subutex®,
• Any medical or psychiatric condition which in the opinion of the investigator would make participation difficult or unsafe,
• Participating in another trial,

Sponsors & Collaborators

• Indivior Inc.: lead

Study Sites (20)

Csst Antibes

Antibes, France

Location

Hopital Paul Guiraud

Bagneux, France

Location

Cssa Bizia

Bayonne, France

Location

Centre Carreire , CH Charles Perrens

Bordeaux, France

Location

CHU de Clermont-Ferrand, Centre Méthadone

Clermont-Ferrand, France

Location

Service d'addictologie, Hopital de Dole

Dole, France

Location

CSST NAUTILIA (Ex Alinea)

Le Havre, France

Location

CSST Le Cèdre Bleu

Lille, France

Location

Centre Hospitalier Esquirol - Intersecteur, Regional Soins en Addictologie

Limoges, France

Location

Centre Baudelaire

Metz, France

Location

Csst de Montauban

Montauban, France

Location

CSST Centre Hospitalier

Nice, France

Location

CSST Logos

Nîmes, France

Location

Hôpital Caremeau

Nîmes, France

Location

Csst Espace Murger

Paris, France

Location

Hôpital Saint Anne

Paris, France

Location

Centre L'Envol (Csst)

Rennes, France

Location

Centre Baudelaire

Thionville, France

Location

Hopital Joseph Ducuing

Toulouse, France

Location

CSST Centre Port Bretagne CH Charles Perrens

Tours, France

Location

MeSH Terms

Conditions

Substance Abuse, Intravenous

Interventions

Buprenorphine; Naloxone; Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Didier TOUZEAU, MD

  Hôpital Paul Guiraud, Bagneux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2009
• First Posted: August 7, 2009
• Study Start: August 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2011
• Last Updated: November 30, 2012

Record last verified: 2010-01

Locations

FR (20)