NCT01759446

Abuse Potential of Intranasal VYCAVERT Tablets (Hydrocodone Bitartrate/Acetaminophen) in Recreational Opioid Users

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Acura Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Opioid-Related Disorders

Interventions

Type	Name	Description
DRUG	Placebo taken first	Snorted in both nostrils within 5 minutes; 48 hours washout between doses
DRUG	Generic H/A taken first	Snorted in both nostrils within 5 minutes; 48 hours washout between doses
DRUG	Vycavert taken first	Snorted in both nostrils within 5 minutes; 48 hours washout between doses
DRUG	Generic H/A plus i taken first	Snorted in both nostrils within 5 minutes; 48 hours washout between doses
DRUG	Generic H/A plus p taken first	Snorted in both nostrils within 5 minutes; 48 hours washout between doses

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2013-01-03
• Last updated: 2018-11-01
• Results posted: 2018-11-01

Locations

1 site across 1 country: United States