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Study to Evaluate the Subjective Effects of PTI-801 in Non-Physically Dependent Subjects With a History of Drug Abuse

NCT00734461 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2016-05-02

No results posted yet for this study

Summary

This is a single-center, randomized, 7-way crossover, double-blind, active and placebo-controlled study to evaluate the subjective effects of oxycodone combined with ultra-low dose naltrexone in comparison to oxycodone alone in non-physically dependent subjects with a history of opioid abuse. Approximately 14 subjects will be randomized to one of fourteen sequences selected from a balanced 7x7 Latin square design and its mirror image.

Conditions

  • Opioid-Related Disorders

Interventions

DRUG

oxycodone and naltrexone

tablets containing 20 mg or 40 mg oxycodone / tablets containing 20 mg or 40 mg oxycodone combined w/0.001 mg or 0.0001 mg naltrexone

Sponsors & Collaborators

  • Pain Therapeutics

    lead INDUSTRY

Principal Investigators

  • George E Bigelow, PhD · Johns Hopkins School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2009-03-31
Completion
2009-03-31

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 NCT00734461 on ClinicalTrials.gov