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Opioid Users | Abuse Potential Study of PF-00345439

Opioid Users research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - 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. Exclusion Criteria: - 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).

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Opioid Users

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:CapsuleTaken once

Drug:PF-0034543940 mg capsule swallowed whole, taken once

Drug:PF-0034543940 mg capsule chewed, taken once

Drug:oxycodone40 mg solution, taken once

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Treatment APlacebo solution +placebo capsule + placebo capsule chewed.

Treatment BPF-00345439 taken whole + placebo solution + placebo chewed

Treatment CPF-00345439 chewed + placebo solution + placebo taken whole

Treatment DOxycodone HCl immediate-release 40 mg tablets (eg, 2 x 5 mg + 1 x 30 mg) + placebo taken whole + placebo chewed

Study Status

Completed

Start Date: November 2013

Completed Date: August 2014

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Drug Liking: Peak Effect (Emax)

Secondary Outcome: Take Drug Again Effect at 24 Hours

Study sponsors, principal investigator, and references

Principal Investigator: Pfizer CT.gov Call Center

Lead Sponsor: Pain Therapeutics

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01986283

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