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

Indivior

Status and phase: Completed; Phase 4

Conditions: Opioid Dependency

Treatments: Drug: Buprenorphine (Subutex); Drug: Buprenorphine/naloxone (Suboxone)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00955162

BU0902

Details and patient eligibility

About

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.

Enrollment: 270 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

Subutex

Active Comparator group

Treatment:

Drug: Buprenorphine (Subutex)

Suboxone

Experimental group

Treatment:

Drug: Buprenorphine/naloxone (Suboxone)