MedTrace Logo

Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users

NCT01030406 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2018-11-01

Study results available
· View outcomes & findings →

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.

Conditions

  • Opioid Abuse

Interventions

DRUG

40/0mg taken first

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

DRUG

80/0mg taken first

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

DRUG

40/240mg taken first

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

DRUG

80/480mg taken first

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

DRUG

0/0mg taken first

Placebo All arms taken with a 48 hour washout between doses

Sponsors & Collaborators

  • King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • 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
2010-01-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States

Study Locations

More Related Trials

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 NCT01030406 on ClinicalTrials.gov