A Study of the Abuse Liability Potential of ALKS 5461 in Healthy, Non-Dependent, Recreational Opioid Users

2015-04-29 15:38:23 | BioPortfolio


This study will evaluate the abuse potential of ALKS 5461.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment




ALKS 5461, Buprenorphine, Placebo


Alkermes Investigational Site
Overland Park
United States




Alkermes, Inc.

Results (where available)

View Results


Published on BioPortfolio: 2015-04-29T15:38:23-0400

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A Drug-drug Interaction Study of ALKS 5461 in Healthy Volunteers

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A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)

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A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study

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A Water Consumption Study of ALKS 5461 in Healthy Volunteers

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A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)

This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant therapy.

PubMed Articles [5268 Associated PubMed Articles listed on BioPortfolio]

Abuse Potential of Buprenorphine/Samidorphan Combination Compared to Buprenorphine and Placebo: A Phase 1 Randomized Controlled Trial.

Buprenorphine/samidorphan combination (BUP/SAM) is an opioid system modulator being investigated as adjunctive treatment for major depressive disorder. BUP/SAM is a fixed-dose combination of buprenorp...

Copper-CX-5461: A novel liposomal formulation for a small molecule rRNA synthesis inhibitor.

CX-5461 is currently in Phase I/II clinical trials for advanced hematologic malignancies and triple negative or BRCA-deficient breast cancer. The compound is currently administered to patients intrave...

Opioid system modulators buprenorphine and samidorphan alter behavior and extracellular neurotransmitter concentrations in the Wistar Kyoto rat.

Approximately two-thirds of major depressive disorder (MDD) patients do not respond adequately to current therapies. BUP/SAM (ALKS 5461), a combination of buprenorphine (BUP) and samidorphan (SAM), is...

High buprenorphine-related mortality is persistent in Finland.

Sublingual buprenorphine is used in opioid maintenance treatment but buprenorphine is also widely abused and causes fatal poisonings. The aim of this study was to investigate buprenorphine-positive fa...

Pharmacokinetics and physiologic/behavioral effects of buprenorphine administered sublingually and intravenously to neonatal foals.

Buprenorphine is absorbed following sublingual administration, which would be a low-stress delivery route in foals. However, the pharmacokinetics/pharmacodynamics are not described in foals. Six healt...

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.

Healthy People Programs are a set of health objectives to be used by governments, communities, professional organizations, and others to help develop programs to improve health. It builds on initiatives pursued over the past two decades beginning with the 1979 Surgeon General's Report, Healthy People, Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and Healthy People 2010. These established national health objectives and served as the basis for the development of state and community plans. These are administered by the Office of Disease Prevention and Health Promotion (ODPHP). Similar programs are conducted by other national governments.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

Governmental guidelines and objectives pertaining to public food supply and nutrition including recommendations for healthy diet and changes in food habits to ensure healthy diet.

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