Study to Evaluate the Subjective Effects of PTI-801 in Non-Physically Dependent Subjects With a History of Drug Abuse
Completed
Pain Therapeutics
Phase 2
2007-08-01
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.
Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain
Completed
Pfizer
Phase 3
2010-12-01
The study will provide information to assess the benefits versus risks of extended exposure
to oxycodone HCl and naltrexone HCl extended-release capsules in a chronic noncancer pain
population.
Healthy Volunteers Study to Estimate the Effects of Food on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Formulation of Oxycodone With Sequestered Naltrexone
Completed
Pfizer
Phase 1
2011-10-01
The purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets
on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an
extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered
naltrexone 4.8 mg.
Buprenorphine and Methadone for Opioid-dependent Chronic Back Pain Patients
Completed
State University of New York at Buffalo
Phase 4
2012-02-01
Chronic pain patients are treated with prescription opioids and many exhibit opioid
addiction. Currently, there are no evidence-based guidelines to better manage patients with
chronic pain and coexistent opioid addiction. This study compares 6-months buprenorphine and
methadone treatment in these patients. The investigators hypothesize that both buprenorphine
and methadone treatment will reduce pain and addiction behaviors and increase functioning in
these patients.
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