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

NCT01759446 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2018-11-01

Study results available
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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

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

Sponsors & Collaborators

  • Acura Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Lynne Webster, MD · Lifetree Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01759446 on ClinicalTrials.gov