Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse

• ClinicalTrials.gov Identifier: NCT00699010
• Recruitment Status: Completed
• First Posted: June 17, 2008
• Results First Posted: October 3, 2018
• Last Update Posted: October 3, 2018
• Sponsor: Acura Pharmaceuticals Inc.
• Information provided by (Responsible Party): Acura Pharmaceuticals Inc.

Study Description

Brief Summary:

The purpose of this study is to assess the abuse liability of 4 times (8 tablets) 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 or disease	Intervention/treatment	Phase
Opioid Abuse	Drug: Acurox 5/30mg taken first; Drug: Oxycodone 5mg taken first	Phase 2

Detailed Description:

In the Treatment Phase, subjects randomly received oxycodone HCl 40 mg administered in combination with niacin 240 mg and oxycodone HCl 40 mg alone in crossover design. 15 subjects were randomized to receive oxycodone/niacin first followed by oxycodone with a 48 hour washout between doses. 15 subjects randomized to receive oxycodone before the oxycodone/naicin dose with a 48 hour washout between doses. The purpose of the Treatment Phase was to assess the abuse liability and abuse deterrence potential of 4 times the recommended 2-tablet dose of Acurox® Tablets 5/30 mg versus oxycodone HCl 40 mg alone (8 tablets per dose).

All 30 subjects received a single dose of each study treatment. Subjects were fasted prior to dosing on all dose days.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: March 2008
• Actual Primary Completion Date: August 2008
• Actual Study Completion Date: August 2008

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Acurox 5/30mg taken first; oxycodone HCl/Niacin 5/30mg tablets; 8 tablets per dose	Drug: Acurox 5/30mg taken first; followed by oxycodone 5mg with 48 hour washout
Active Comparator: Oxycodone 5mg taken first; oxycodone HCl 5mg tablets; 8 tablets per dose	Drug: Oxycodone 5mg taken first; followed by Acurox 5/30mg with 48 hour washout

Outcome Measures

Primary Outcome Measures :

1. Drug Like/Dislike Effect at 30 Minutes Post Dose (E 30 Min) [ Time Frame: Effects assessed at 0.5 hours after dosing. ]
   "Do you dislike or like the drug effect you are feeling now?" This question was rated on a 1 to 29 point VAS scale that was anchored in the center with "neither like nor dislike" (14), on the left with "dislike an awful lot" (1), and on the right with "like an awful lot" (29).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Acura Pharmaceuticals Inc.
• ClinicalTrials.gov Identifier: NCT00699010
• Other Study ID Numbers: AP-ADF-111
• First Posted: June 17, 2008
• Results First Posted: October 3, 2018
• Last Update Posted: October 3, 2018
• Last Verified: October 2008

Keywords provided by Acura Pharmaceuticals Inc.:

Abuse Liability; Abuse Prevention; Abuse Resistance; Abuse Deterrence

Additional relevant MeSH terms:

Opioid-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Niacin; Oxycodone; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Vasodilator Agents; Vitamin B Complex; Vitamins; Micronutrients; Nutrients; Growth Substances