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Phase 1 Study to Evaluate RDC-0313 Coadministered With Buprenorphine to Opioid-Experienced Healthy Adults

2014-08-27 03:16:46 | BioPortfolio

Summary

This is a single site, double-blind, randomized, placebo-controlled, crossover study to assess the pharmacodynamics (PD) of RDC-0313 coadministered with buprenorphine in 12 healthy, opioid-experienced, non-treatment-seeking subjects.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Substance-Related Disorders

Intervention

RDC-0313 + Buprenorphine, Placebo

Location

Langley Porter Psychiatric Hospital
San Francisco
California
United States
94143

Status

Recruiting

Source

National Institute on Drug Abuse (NIDA)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:46-0400

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A Study of RDC-0313 Administered to Healthy Adults

The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of RDC-0313 following oral administration.

A Study of ALKS33 (RDC-0313) in Adults With Alcohol Dependence

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Buprenorphine Pharmacology Related to Addiction Treatment - 18

The purpose of this study is to examine the interactions between buprenorphine and naltrexone, and to assess how they may directly impact the clinical issues involving: transferring patien...

Alternate Day Buprenorphine Administration, Phase XII - 17

The purpose of this study is to determine if six times daily buprenorphine dose is effective in achieving 120 hour buprenorphine dosing.

Buprenorphine Pharmacology Related to Addiction Treatment - 21

The purpose of this study is to examine if chronic buprenorphine administration will generate supersensitivity to opiates.

PubMed Articles [15223 Associated PubMed Articles listed on BioPortfolio]

Interest in prescribing buprenorphine among resident and attending physicians at an urban teaching clinic.

Opioid use disorders are a major medical and public health concern. Buprenorphine is approved for the treatment of opioid use disorders; however, a shortage of physicians prescribing buprenorphine is ...

At the Expense of a Life: Race, Class, and the Meaning of Buprenorphine in Pharmaceuticalized "Care".

Office-based buprenorphine maintenance has been legalized and promoted as a treatment approach that not only expands access to care, but also reduces the stigma of addiction treatment by placing it in...

The associations between psychotic experiences, and substance use and substance use disorders: Findings from the World Health Organisation World Mental Health Surveys.

Prior research has found bidirectional associations between psychotic experiences (PEs), and selected substance use disorders. We aimed to extend this research by examining the bidirectional associati...

National substance use patterns on Twitter.

We examined openly shared substance-related tweets to estimate prevalent sentiment around substance use and identify popular substance use activities. Additionally, we investigated associations betwee...

A Systematic, Intensive Statistical Investigation of Data from the Comprehensive Analysis of Reported Drugs (CARD) for Compliance and Illicit Opioid Abstinence in Substance Addiction Treatment with Buprenorphine/naloxone.

Buprenorphine and naloxone (bup/nal), a combination partial mu receptor agonist and low-dose delta mu antagonist, is presently recommended and used to treat opioid-use disorder. However, a literature ...

Medical and Biotech [MESH] Definitions

Disorders related to substance abuse, the side effects of a medication, toxin exposure, and ALCOHOL-RELATED DISORDERS.

These disorders are related to both SCHIZOPHRENIA SPECTRUM AND RELATED DISORDERS and DEPRESSIVE DISORDERS in terms of symptomatology, family history, and genetics. (DSM-V) .

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.

Psychotic organic mental disorders resulting from the toxic effect of drugs and chemicals or other harmful substance.

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