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

NCT00699010 | Completed Phase 2 Results

• 1 other identifier: AP-ADF-111
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Abuse

Keywords

Abuse Liability; Abuse Prevention; Abuse Resistance; Abuse Deterrence

Outcome Measures

Primary Outcomes (1)

• Drug Like/Dislike Effect at 30 Minutes Post Dose (E 30 Min)

  "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).

  Effects assessed at 0.5 hours after dosing.

Study Arms (2)

Acurox 5/30mg taken first

ACTIVE COMPARATOR

oxycodone HCl/Niacin 5/30mg tablets; 8 tablets per dose

Drug: Acurox 5/30mg taken first

Oxycodone 5mg taken first

ACTIVE COMPARATOR

oxycodone HCl 5mg tablets; 8 tablets per dose

Drug: Oxycodone 5mg taken first

Interventions

Acurox 5/30mg taken first DRUG

followed by oxycodone 5mg with 48 hour washout

Acurox 5/30mg taken first

Oxycodone 5mg taken first DRUG

followed by Acurox 5/30mg with 48 hour washout

Oxycodone 5mg taken first

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acura Pharmaceuticals Inc.: lead

Study Sites (1)

Johns Hopkins Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Ron Spivey
• Organization: Acura Pharma

rspivey@acurapharm.com

847-705-7709

Study Officials

• Donald R Jasinski, MD

  Johns Hopkins Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2008
• First Posted: June 17, 2008
• Study Start: March 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: October 3, 2018
• Results First Posted: October 3, 2018

Record last verified: 2008-10

Locations

US (1)