Full Text View
Tabular View
No Study Results Posted
Related Studies
Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France ("RIME")
This study is not yet open for participant recruitment.
Verified by Reckitt Benckiser Pharmaceuticals, Inc, August 2009
First Received: August 5, 2009   Last Updated: August 6, 2009   History of Changes
Sponsored by: Reckitt Benckiser Pharmaceuticals, Inc
Information provided by: Reckitt Benckiser Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00955162
  Purpose

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.


Condition Intervention Phase
Opioid Dependency
Drug: Buprenorphine (Subutex)
Drug: Buprenorphine/naloxone (Suboxone)
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: A Multicentre, Randomised, Open-label, Active-controlled Trial of the Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France

Resource links provided by NLM:


Further study details as provided by Reckitt Benckiser Pharmaceuticals, Inc:

Primary Outcome Measures:
  • number of study drug injections per week [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Addiction severity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Withdrawal severity [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: August 2009
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Subutex: Active Comparator Drug: Buprenorphine (Subutex)
Sublingual tablet
Suboxone: Experimental Drug: Buprenorphine/naloxone (Suboxone)
Sublingual tablet

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955162

Locations
France
Paris, France
Sponsors and Collaborators
Reckitt Benckiser Pharmaceuticals, Inc
Investigators
Principal Investigator: Didier TOUZEAU, MD Hôpital Paul Guiraud, Bagneux
  More Information

No publications provided

Responsible Party: Reckitt Benckiser Pharmaceuticals, Inc ( David Crossley, Clinical Project Manager )
Study ID Numbers: BU0902
Study First Received: August 5, 2009
Last Updated: August 6, 2009
ClinicalTrials.gov Identifier: NCT00955162     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by Reckitt Benckiser Pharmaceuticals, Inc:
Substance Abuse, Intravenous
Buprenorphine

Study placed in the following topic categories:
Buprenorphine
Narcotic Antagonists
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Analgesics
Analgesics, Opioid
Naloxone
Substance Abuse, Intravenous

Additional relevant MeSH terms:
Physiological Effects of Drugs
Narcotic Antagonists
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Naloxone
Buprenorphine
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on September 11, 2009