Buprenorphine/Naloxone for Opiate-Dependence Treatment - 1

2014-07-23 16:56:00 | BioPortfolio


The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment. The developmental objective for this combination product is an expansion of therapeutic options for the treatment of opiate dependence.


This multicenter pivotal clinical trial was comprised of two phases. The first phase, which was four weeks in length, was double-blind placebo controlled and was primarily used to evaluate the efficacy of buprenorphine/naloxone. The second phase, lasting 48 weeks, was primarily conducted to determine the safety of buprenorphine/naloxone.

Study Design

Primary Purpose: Treatment


Opioid-Related Disorders




Cincinnati MDRU
United States




National Institute on Drug Abuse (NIDA)

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T16:56:00-0400

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Medical and Biotech [MESH] Definitions

A derivative of the opioid alkaloid THEBAINE that is a more potent and longer lasting analgesic than MORPHINE. It appears to act as a partial agonist at mu and kappa opioid receptors and as an antagonist at delta receptors. The lack of delta-agonist activity has been suggested to account for the observation that buprenorphine tolerance may not develop with chronic use.

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