Clinical trial NCT01986283: Abuse Potential Study of PF-00345439
Official title: A Randomized, Double-blind, Triple-dummy, Placebo Controlled, Single-dose, 4-way Crossover Study To Determine The Relative Abuse Potential Of Pf-00345439 (Oxycodone Extended Release Capsules) Compared To Immediate-release Oxycodone And Placebo When Administered Orally Whole And/or Chewed To Non-dependent, Recreational Opioid Users Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid Users
Keywords: Abuse potential
PF-00345439
drug abuse
Lead sponsor: PainT
Sponsor class: UNKNOWN
First posted: 2013-11-18
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Drug Liking: Peak Effect (Emax)
timeFrame: 12 hours
measure: High: Peak Effect (Emax)
timeFrame: 12 hours
measure: Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours
timeFrame: 2 hours
measure: High: Area Under Effect Curve (AUE) From 0-2 Hours
timeFrame: 2 hours
Secondary outcomes:
measure: Take Drug Again Effect at 24 Hours
timeFrame: 24 hours
measure: Overall Drug Liking
timeFrame: 24 hours
measure: Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-1 Hour
timeFrame: 1 hour
measure: Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour
timeFrame: 1 hour
measure: Chewing Duration
timeFrame: 5 min
measure: Taste: Subjective Experience from Chewing
timeFrame: 5 min
measure: Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-2 Hours
timeFrame: 2 hours
measure: Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-3 Hours
timeFrame: 3 hours
measure: Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-12 Hours
timeFrame: 12 hours
measure: Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours
timeFrame: 2 hours
measure: Pupillometry: Area Under Effect Curve (AUE) From 0-3 Hours
timeFrame: 3 hours
measure: Pupillometry: Area Under Effect Curve (AUE) From 0-12 Hours
timeFrame: 12 hours
measure: High: Area Under Effect Curve (AUE) From 0-1 Hour
timeFrame: 1 hour
measure: High: Area Under Effect Curve (AUE) From 0-3 Hours
timeFrame: 3 hours
measure: High: Area Under Effect Curve (AUE) From 0-12 Hours
timeFrame: 12 hours
measure: Good Drug Effects: Area Under Drug Effect Curve (AUE) From 0-1 Hour
timeFrame: 1 hour
measure: Good Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours
timeFrame: 2 hours
measure: Good Drug Effects: Area Under Effect Curve (AUE) From 0-3 Hours
timeFrame: 3 hours
measure: Good Drug Effects: Area Under Effect Curve (AUE) From 0-12 Hours
timeFrame: 12 hours
measure: Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour
timeFrame: 1 hour
measure: Bad Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours
timeFrame: 2 hour
measure: Bad Drug Effects: Area Under Effect Curve (AUE) From 0-3 Hours
timeFrame: 3 hours
measure: Bad Drug Effects: Area Under Effect Curve (AUE) From 0-12 Hours
timeFrame: 12 hours
measure: Feeling Sick: Area Under Effect Curve (AUE) From 0-1 Hour
timeFrame: 1 hour
measure: Feeling Sick: Area Under Effect Curve (AUE) From 0-2 Hours
timeFrame: 2 hours
measure: Feeling Sick: Area Under Effect Curve (AUE) From 0-3 Hours
timeFrame: 3 hours
measure: Feeling Sick: Area Under Effect Curve (AUE) From 0-12 Hours
timeFrame: 12 hours
measure: Nausea: Area Under Effect Curve (AUE) From 0-1 Hour
timeFrame: 1 hour
measure: Nausea: Area Under Effect Curve (AUE) From 0-2 Hours
timeFrame: 2 hours
measure: Nausea: Area Under Effect Curve (AUE) From 0-3 Hours
timeFrame: 3 hours
measure: Nausea: Area Under Effect Curve (AUE) From 0-12 Hours
timeFrame: 12 hours
measure: Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour
timeFrame: 1 hour
measure: Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours
timeFrame: 2 hours
measure: Sleepy: Area Under Effect Curve (AUE) From 0-3 Hours
timeFrame: 3 hours
measure: Sleepy: Area Under Effect Curve (AUE) From 0-12 Hour
timeFrame: 12 hours
measure: Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour
timeFrame: 1 hour
measure: Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours
timeFrame: 2 hours
measure: Dizzy: Area Under Effect Curve (AUE) From 0-3 Hours
timeFrame: 3 hours
measure: Dizzy: Area Under Effect Curve (AUE) From 0-12 Hours
timeFrame: 12 hours
measure: Bad Effects: Peak Effect (Emax)
timeFrame: 12 hours
measure: Nausea: Peak Effect (Emax)
timeFrame: 12 hours
measure: Feel Sick: Peak Effect (Emax)
timeFrame: 12 hours
measure: Sleepy: Peak Effect (Emax)
timeFrame: 12 hours
measure: Dizzy: Peak Effect (Emax)
timeFrame: 12 hours
measure: Pupillometry: Peak Effect (Emax)
timeFrame: 12 hours
measure: Good Drug Effects: Peak Effect (Emax)
timeFrame: 12 hours
measure: Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour
timeFrame: 1 hour
measure: Drug Liking: Area Under Effect Curve (AUE) From 0-3 Hours
timeFrame: 3 hours
measure: Drug Liking: Area Under Effect Curve (AUE) From 0-12 Hours
timeFrame: 12 hours
measure: Drug Liking: Time to Maximum (Peak) Effect (TEmax)
timeFrame: 12 hours
measure: High: Time to Maximum (Peak) Effect (TEmax)
timeFrame: 12 hours
measure: Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)
timeFrame: 12 hours
measure: Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)
timeFrame: 12 hours
measure: Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)
timeFrame: 12 hours
measure: Feel Sick: Time to Maximum (Peak) Effect (TEmax)
timeFrame: 12 hours
measure: Nausea: Time to Maximum (Peak) Effect (TEmax)
timeFrame: 12 hours
measure: Sleepy: Time to Maximum (Peak) Effect (TEmax)
timeFrame: 12 hours
measure: Dizzy: Time to Maximum (Peak) Effect (TEmax)
timeFrame: 12 hours
measure: Pupillometry: Time to Maximum (Peak) Effect (TEmax)
timeFrame: 12 hours
measure: Any Drug Effects: Peak Effect (Emax)
timeFrame: 12 hours
measure: Texture: Subjective Experience from Chewing
timeFrame: 5 mins
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 24hr
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 24hr
measure: Area under the curve (AUC)
timeFrame: 24hr
measure: Systemic Clearance (CL)
timeFrame: 24hr
measure: volume of distribution (Vd)
timeFrame: 24hr
measure: Half-Life (t1/2)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: