CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Acurox 5/30mg taken first +1 moredrug
Likely dose
Acurox 5/30mg 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/NCT00699010
NCT00699010Phase 2Completed

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

Acura Pharmaceuticals Inc.·interventional·Posted Jun 17, 2008·Updated Oct 3, 2018

In Brief

A Phase 2 clinical trial evaluating Acurox 5/30mg taken first and Oxycodone 5mg taken first for Opioid Abuse. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Abuse
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 17, 2008
Enrollment StartMar 1, 2008
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 18.0 years ago

Interventions

Acurox 5/30mg taken firstdrug

followed by oxycodone 5mg with 48 hour washout

Oxycodone 5mg taken firstdrug

followed by Acurox 5/30mg with 48 hour washout