CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Placebo taken first +4 moredrug
Likely dose
Not stated in 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/NCT01759446
NCT01759446Phase 2Completed

A Single-center, Randomized, Double-blind, Active- and Placebo Controlled, 5-way Crossover Study Assessing the Abuse Potential of Intranasally Administered VYCAVERT Tablets in Non-dependent Recreational Opioid Users.

Acura Pharmaceuticals Inc.·interventional·Posted Jan 3, 2013·Updated Nov 1, 2018

In Brief

A Phase 2 clinical trial evaluating Placebo taken first, Generic H/A taken first, and 3 other interventions for Opioid-Related Disorders. Completed, enrolled 44 participants across 1 site.

Detailed Summary

To determine the relative abuse potential of VYCAVERT (hydrocodone bitartrate and acetaminophen) compared to GENERIC H/A (hydrocodone bitartrate and acetaminophen) when crushed and administered intranasally to non dependent, recreational opioid users.

Study Details

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

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 3, 2013
Enrollment StartFeb 1, 2013
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.5 years ago

Interventions

Placebo taken firstdrug

Snorted in both nostrils within 5 minutes; 48 hours washout between doses

Generic H/A taken firstdrug

Snorted in both nostrils within 5 minutes; 48 hours washout between doses

Vycavert taken firstdrug

Snorted in both nostrils within 5 minutes; 48 hours washout between doses

Generic H/A plus i taken firstdrug

Snorted in both nostrils within 5 minutes; 48 hours washout between doses

Generic H/A plus p taken firstdrug

Snorted in both nostrils within 5 minutes; 48 hours washout between doses