Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse - Full Text View

Sponsor:	Acura Pharmaceuticals Inc.
Information provided by:	Acura Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00699010

Purpose

The purpose of this study is: (1) to assess the effect of oxycodone HCl on niacin-induced dysphoric effects when oxycodone HCl is administered in combination with niacin in subjects with a history of opioid abuse; (2) to assess the abuse liability of 4 times the usual recommended dose of Acurox (oxycodone HCl 40 mg plus niacin 240 mg) versus oxycodone HCL 40 mg alone in subjects with a history of opioid abuse.

Condition	Intervention	Phase
Opioid Abuse	Drug: Niacin Drug: Oxycodone HCL plus Niacin Drug: Placebo Drug: Oxycodone HCl	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Single-Center, Randomized, Double-Blind Assessment of the Abuse Liability of Acurox (Oxycodone HCl and Niacin) Tablets in Subjects With a History of Opioid Abuse

Resource links provided by NLM:

Drug Information available for: Niacin Oxycodone Niacinamide Oxycodone hydrochloride Niacin hydrochloride

U.S. FDA Resources

Further study details as provided by Acura Pharmaceuticals Inc.:

Primary Outcome Measures:

Evaluation of the Drug Rating Questionnaire-Subject (DRQS), and the Addiction Research Center Inventory (ARCI) [ Time Frame: Days 1, 3, 5, 7, and 9 ] [ Designated as safety issue: Yes ]
Evaluation of the DRQS, the ARCI, the Street Value Assessment Questionnaire (SVAQ), and the Treatment Enjoyment Assessment Questionnaire (TEAQ) [ Time Frame: Day 1, 3, 5, 7, 8, 9, and 10 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	March 2008
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: Niacin Niacin 240 mg every 48 hours
B: Active Comparator	Drug: Oxycodone HCL plus Niacin Oxycodone HCL 40 mg plus Niacin 240 mg every 48 hours
C: Placebo Comparator	Drug: Placebo Placebo every 48 hours
D: Active Comparator	Drug: Oxycodone HCL plus Niacin Oxycodone HCl 40 mg plus Niacin 240 mg every 48 hours
E: Active Comparator	Drug: Oxycodone HCl Oxycodone HCl 40 mg every 48 hours

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subject is male or female between 18 and 55 years of age
Subject meets DSM-IV Criteria for the Diagnosis of Opioid Substance Abuse and subject is unlikely to experience an idiosyncratic reaction or respiratory depression after ingesting 40 mg of oxycodone
Body weight is not more than 20% above or below ideal body weight
Subject agrees to abstain from any Rx or OTC drugs (except as authorized by the Investigator) or alcohol
Subject is in generally good health
Subject is reliable, willing, cooperative, able to communicate effectively, and has a minimum of a 6th grade reading level
Subject has an acceptable score on the MMSE for cognitive impairment
For women of child-bearing potential: woman is not pregnant and not nursing, and is practicing an acceptable method of birth control

Exclusion Criteria:

Subject has a disease that may endanger the subject or the validity of the data
Subject is currently physically dependent on opiates or alcohol
Subject was exposed to any investigational drug within 30 days prior to the inpatient phase
Subject has a history of hypersensitivity to any drug, or a known allergy to any component of the study drug formulation
Subject has a positive urine drug screen for a non-opiate drug
Subject has a predisposing condition that may place the subject at risk for receiving niacin or oxycodone, or confound the study analyses
Subject ingested niacin at doses higher than SDI within 14 days prior to the inpatient phase
Subject has an abnormal bleeding tendency

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699010

Locations

United States, Maryland
Johns Hopkins Medical Center
Baltimore, Maryland, United States, 21224

Sponsors and Collaborators

Acura Pharmaceuticals Inc.

Investigators

Principal Investigator:

Donald R Jasinski, MD

Johns Hopkins Medical Center

More Information

No publications provided

Responsible Party:	Johns Hopkins Medical Center ( Donald R. Jasinski, MD )
Study ID Numbers:	AP-ADF-111
Study First Received:	June 13, 2008
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00699010 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Acura Pharmaceuticals Inc.:

Abuse Liability
Abuse Prevention
Abuse Resistance
Abuse Deterrence

Additional relevant MeSH terms:

Antimetabolites
Vasodilator Agents
Niacinamide
Molecular Mechanisms of Pharmacological Action
Oxycodone
Physiological Effects of Drugs
Disorders of Environmental Origin
Nicotinic Acids
Mental Disorders
Sensory System Agents
Therapeutic Uses
Vitamins
Substance-Related Disorders

Micronutrients
Analgesics
Analgesics, Opioid
Vitamin B Complex
Antilipemic Agents
Growth Substances
Central Nervous System Depressants
Narcotics
Cardiovascular Agents
Pharmacologic Actions
Peripheral Nervous System Agents
Niacin
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 05, 2009