Buprenorphine/Naloxone for Opiate-Dependence Treatment - 1

13:04 EDT 4th July 2015 | 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

Clinical Trials [709 Associated Clinical Trials listed on BioPortfolio]

Effects of Buprenorphine/Naloxone Administered in Different Ways For Treating Opioid Dependence

Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine. The...

Abuse Potential of Buprenorphine/Naloxone

Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine. Th...

Abuse Potential of Buprenorphine and Naloxone in Non-Dependent Opioid Users

Buprenorphine is a medication used to treat opioid addiction, but individuals who use this drug are at risk of abusing it. A buprenorphine and naloxone combination may reduce the likelihoo...

Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-1 - 4

The purpose of this study is to assess the abuse liability and examine the reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in buprenorphine-naloxon...

Buprenorphine/Naloxone - Facilitated Rehabilitation for Opioid Dependent Adolescents - 1

The purpose of this study is to compare two 3-month treatments for adolescents/young adults who are addicted to heroin: buprenorphine/naloxone combined with psychosocial therapy and treatm...

PubMed Articles [14391 Associated PubMed Articles listed on BioPortfolio]

Group Medication Management for Buprenorphine/Naloxone in Opioid-Dependent Veterans.

Substance use disorders are a key concern among US veterans. Substance use disorder pharmacotherapies with support for effectiveness are limited. Buprenorphine/naloxone (Suboxone) is an effective opio...

Initial response as a predictor of 12-week buprenorphine-naloxone treatment response in a prescription opioid-dependent population.

Initial medication response has been shown to predict treatment outcome across a variety of substance use disorders, but no studies have examined the predictive power of initial response to buprenorph...

Liver enzyme levels in adolescent patients treated with buprenorphine and additional psychotropic agents.

Abstract Background: There are limited efficacy and safety data for buprenorphine/naloxone treatment in adolescents, and little is known about the incidence and prevalence of liver function abnormalit...

Predictors of long term opioid withdrawal outcome after short-term stabilization with buprenorphine.

We aim to examine predictors of opiate abstinence status 3 months after the end of buprenorphine/naloxone treatment for opioid-dependent participants.

Practice Guidance for Buprenorphine for the Treatment of Opioid Use Disorders: Results of an Expert Panel Process.

Although numbers of physicians credentialed to prescribe buprenorphine has increased over time, many credentialed physicians may be reluctant to treat individuals with opioid use disorders due to disc...

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.

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.

A specific opiate antagonist that has no agonist activity. It is a competitive antagonist at mu, delta, and kappa opioid receptors.

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