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.

Tracking Information

• First Submitted Date: June 13, 2008
• First Posted Date: June 17, 2008
• Results First Submitted Date: June 27, 2018
• Results First Posted Date: October 3, 2018
• Last Update Posted Date: October 3, 2018
• Study Start Date: March 2008
• Actual Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 6, 2018)

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).

Original Primary Outcome Measures (submitted: June 16, 2008)

• Evaluation of the Drug Rating Questionnaire-Subject (DRQS), and the Addiction Research Center Inventory (ARCI) [ Time Frame: Days 1, 3, 5, 7, and 9 ]
• 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 ]

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse
• 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
• 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.

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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Opioid Abuse

Intervention

• Drug: Acurox 5/30mg taken first
  followed by oxycodone 5mg with 48 hour washout
• Drug: Oxycodone 5mg taken first
  followed by Acurox 5/30mg with 48 hour washout

Study Arms

• Active Comparator: Acurox 5/30mg taken first
  oxycodone HCl/Niacin 5/30mg tablets; 8 tablets per dose
  Intervention: Drug: Acurox 5/30mg taken first
• Active Comparator: Oxycodone 5mg taken first
  oxycodone HCl 5mg tablets; 8 tablets per dose
  Intervention: Drug: Oxycodone 5mg taken first

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 16, 2008): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 2008
• Actual Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00699010
• Other Study ID Numbers: AP-ADF-111
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Acura Pharmaceuticals Inc.
• Study Sponsor: Acura Pharmaceuticals Inc.
• Collaborators: Not Provided

Investigators

• Principal Investigator: Donald R Jasinski, MD; Johns Hopkins Medical Center

• PRS Account: Acura Pharmaceuticals Inc.
• Verification Date: October 2008