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Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse

NCT00699010 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-10-03

Study results available
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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.

Conditions

  • Opioid Abuse

Interventions

DRUG

Acurox 5/30mg taken first

followed by oxycodone 5mg with 48 hour washout

DRUG

Oxycodone 5mg taken first

followed by Acurox 5/30mg with 48 hour washout

Sponsors & Collaborators

  • Acura Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Donald R Jasinski, MD · Johns Hopkins Medical Center

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
2008-03-31
Primary Completion
2008-08-31
Completion
2008-08-31

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 NCT00699010 on ClinicalTrials.gov