Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT00699010
Study type Interventional
Source Acura Pharmaceuticals Inc.
Contact
Status Completed
Phase Phase 2
Start date March 2008
Completion date August 2008

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04839978 - Community Trial in the Cherokee Nation N/A
Completed NCT05593341 - Opioid Education in Total Knee Arthroplasty N/A
Terminated NCT04495374 - Oral Pregabalin as Preemptive Analgesia in Abdominal Hysterectomy Phase 4
Terminated NCT03822962 - Pain Management Following Sinus Surgery Early Phase 1
Completed NCT03936985 - Validation of a Community Pharmacy-Based Prescription Drug Monitoring Program Risk Screening Tool
Active, not recruiting NCT01740414 - Effects of Ibudilast on Oxycodone Self-administration in Opioid Abusers Phase 2
Completed NCT00499746 - The Discriminative Effects of Tramadol in Humans Phase 1/Phase 2
Completed NCT03684681 - The Navigator Trial N/A
Completed NCT04340622 - Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders N/A
Completed NCT04018664 - Oral Abuse Potential Study of Nalbuphine Phase 1
Recruiting NCT05006079 - Opioid/Benzodiazepine Polydrug Abuse: Aim 3 Phase 2
Completed NCT04710069 - Postoperative Opt-In Narcotic Treatment Study N/A
Terminated NCT03992079 - A Multimodal Enhanced Recovery Program in Anorectal Surgery N/A
Active, not recruiting NCT03570099 - Naloxone Treatment in Skåne County - Effect on Drug-related Mortality and Overdose-related Complications
Completed NCT02804152 - Program for Pain & Prescription Opioid Use in Pregnancy N/A
Active, not recruiting NCT01632982 - Mobile Psychosocial Interventions for MMT Clients N/A
Active, not recruiting NCT01136356 - A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals Phase 1/Phase 2
Not yet recruiting NCT05706311 - Community Pharmacy-Based Prescription Drug Monitoring Program Opioid Risk Assessment Tool N/A
Completed NCT03743493 - PCORnet Opioid Surveillance Study
Completed NCT03143855 - Drug Interaction and Subjective Effects of Compounds for Opioid Use Disorder Phase 1