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Buprenorphine/Naloxone for Opiate-Dependence Treatment - 1

2014-07-23 21:56:00 | BioPortfolio

Summary

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.

Description

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

Conditions

Opioid-Related Disorders

Intervention

Buprenorphine/naloxone

Location

Cincinnati MDRU
Cincinnati
Ohio
United States
45220

Status

Completed

Source

National Institute on Drug Abuse (NIDA)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:56:00-0400

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Medical and Biotech [MESH] Definitions

A pharmaceutical preparation that combines buprenorphine, an OPIOID ANALGESIC with naloxone, a NARCOTIC ANTAGONIST to reduce the potential for NARCOTIC DEPENDENCE in the treatment of pain. It may also be used for OPIATE SUBSTITUTION THERAPY.

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.

Disorders related or resulting from abuse or mis-use of opioids.

An opioid antagonist with properties similar to those of NALOXONE; in addition it also possesses some agonist properties. It should be used cautiously; levallorphan reverses severe opioid-induced respiratory depression but may exacerbate respiratory depression such as that induced by alcohol or other non-opioid central depressants. (From Martindale, The Extra Pharmacopoeia, 30th ed, p683)

Medical treatment for opioid dependence using a substitute opiate such as METHADONE or BUPRENORPHINE.

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