Clinical trial NCT00955162: Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France ("RIME")
Official title: A Multicentre, Randomised, Open-label, Active-controlled Trial of the Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opioid Dependency
Keywords: Substance Abuse, Intravenous
Buprenorphine
Lead sponsor: Indivior Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-07
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: number of study drug injections per week
timeFrame: 1 week
Secondary outcomes:
measure: Addiction severity
timeFrame: 3 months
measure: Withdrawal severity
timeFrame: 1 month
Other outcomes:
Locations:
city: Antibes
country: France
facility: Csst Antibes
city: Bagneux
country: France
facility: Hopital Paul Guiraud
city: Bayonne
country: France
facility: Cssa Bizia
city: Bordeaux
country: France
facility: Centre Carreire , CH Charles Perrens
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand, Centre Méthadone
city: Dole
country: France
facility: Service d'addictologie, Hopital de Dole
city: Le Havre
country: France
facility: CSST NAUTILIA (Ex Alinea)
city: Lille
country: France
facility: CSST Le Cèdre Bleu
city: Limoges
country: France
facility: Centre Hospitalier Esquirol - Intersecteur, Regional Soins en Addictologie
city: Metz
country: France
facility: Centre Baudelaire
city: Montauban
country: France
facility: Csst de Montauban
city: Nice
country: France
facility: CSST Centre Hospitalier
city: Nimes
country: France
facility: CSST Logos
city: Nimes
country: France
facility: Hôpital Caremeau
city: Paris
country: France
facility: Csst Espace Murger
city: Paris
country: France
facility: Hôpital Saint Anne
city: Rennes
country: France
facility: Centre L'Envol (Csst)
city: Thionville
country: France
facility: Centre Baudelaire
city: Toulouse
country: France
facility: Hopital Joseph Ducuing
city: Tours
country: France
facility: CSST Centre Port Bretagne CH Charles Perrens
Study officials:
affiliation: Hôpital Paul Guiraud, Bagneux
name: Didier TOUZEAU, MD
role: PRINCIPAL_INVESTIGATOR
References: