A multicentre, randomised, open-label, active-controlled trial of the effectiveness of buprenorphine/naloxone in reducing intravenous buprenorphine misuse in France - RIME Study

Phase 1

• Conditions: For both compounds, substitution treatment for opioid drug dependence, adult subjects with a diagnosis of major heroin dependence. Only for Suboxone, the intention of naloxone is to deter the intravenous misuse.; MedDRA version: 9.1Level: LLTClassification code 10012346Term: Dependence on opiates

• Registration Number: EUCTR2009-010360-41-FR
• Lead Sponsor: Reckitt Benckiser Healthcare (UK) Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-03
• Study Completion: 2012-04-02
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 270

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this trial is to establish the effectiveness of buprenorphine/naloxone in reducing intravenous misuse of buprenorphine in opioid-dependent patients receiving buprenorphine maintenance therapy in France.;Secondary Objective: • To demonstrate the efficacy of buprenorphine/naloxone in reducing use of opioids and other illicit or unprescribed drugs.<br>• To determine effects experienced by patients injecting the study drug.<br>• To identify baseline patient characteristics associated with subsequent reduction of buprenorphine misuse.<br>• To further document the safety of buprenorphine/naloxone.<br>;Primary end point(s): Percentage of patients achieving a 30% reduction of the average weekly number of study drug injections during the randomised treatment period (Day 1 to Day 84 inclusive) as compared to baseline (Day-7 to Day 0).