Abuse Potential Study of PF-00345439

Completed · Phase 1

Conditions studied: Opioid Users

In brief

This study will determine the relative abuse potential of intact and chewed PF-00345439 (Oxycodone Extended-Release Capsules) compared to crushed oxycodone HCL immediate release (IR) tablets and placebo administered orally to non-dependent, recreational opioid users.

Key facts

Study ID

NCT01986283

Run by

Pain Therapeutics

People needed

67

Starts

2013-11-01

Expected to finish

2014-08-01

Last updated by the study team

2016-04-04

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male and/or female subjects between the ages of 18 and 55 years who are recreational opioid users and are NOT dependent on opioids.

You may not qualify if…

• Evidence or history of clinically significant medical conditions.
• Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine).
• Has participated in, is currently participating in, or is seeking treatment for substance-and/or alcohol-related disorders (excluding nicotine and caffeine).
• Has a positive urine drug screen (UDS) excluding tetrahydrocannabinol (THC).
• Has a positive alcohol breath test.
• Has any history of a condition in which an opioid is contraindicated.
• History of sleep apnea in the past 5 years that has not been resolved or corrected.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results .
• Positive test for Hepatitis B, Hepatitis C, or HIV.
• Allergy or history of hypersensitivity to naloxone HCl, oxycodone HCl, other opioids, and/or lactose.
• Any condition possibly affecting drug absorption (eg, gastrectomy).

Where it is running

• Lifetree Clinical Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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