Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Reckitt Benckiser Pharmaceuticals, Inc |
---|---|
Information provided by: | Reckitt Benckiser Pharmaceuticals, Inc |
ClinicalTrials.gov Identifier: | NCT00955162 |
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 |
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
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Substance Abuse, Intravenous Buprenorphine |
Buprenorphine Narcotic Antagonists Central Nervous System Depressants Narcotics Peripheral Nervous System Agents |
Analgesics Analgesics, Opioid Naloxone Substance Abuse, Intravenous |
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 |