CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 49 enrolled
Drug / intervention
40/0mg taken first +4 moredrug
Likely dose
40/0mg taken firstfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01030406
NCT01030406Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users

Acura Pharmaceuticals Inc.·interventional·Posted Dec 11, 2009·Updated Nov 1, 2018

In Brief

A Phase 2 clinical trial evaluating 40/0mg taken first, 80/0mg taken first, and 3 other interventions for Opioid Abuse. Completed, enrolled 49 participants across 1 site.

Detailed Summary

The primary objective of this study is to compare the relative abuse potential of two different doses of orally administered Acurox Tablets to orally administered immediate-release (IR) oxycodone HCl tablets in non-dependent recreational opioid users.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Abuse
CountriesUnited States
CollaboratorsKing Pharmaceuticals is now a wholly owned subsidiary of Pfizer

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 11, 2009
Enrollment StartJan 1, 2010
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.6 years ago

Interventions

40/0mg taken firstdrug

8x Oxycodone/Niacin 5/0mg tablets All arms taken with a 48 hour washout between doses

80/0mg taken firstdrug

8x Oxycodone/Niacin 10/0mg tablets All arms taken with a 48 hour washout between doses

40/240mg taken firstdrug

8x Oxycodone/Niacin 5/30mg tablets All arms taken with a 48 hour washout between doses

80/480mg taken firstdrug

8x Oxycodone/Niacin 10/60mg tablets All arms taken with a 48 hour washout between doses

0/0mg taken firstdrug

Placebo All arms taken with a 48 hour washout between doses