Abuse Potential Study of PF-00345439

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Opioid Users

Intervention / Treatment
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* Drug: Capsule
* Drug: PF-00345439
* Drug: PF-00345439
* Drug: oxycodone


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Treatment A<br>Placebo solution +placebo capsule + placebo capsule chewed. | Drug: Capsule<br>* Taken once<br>|
| Experimental: Treatment B<br>PF-00345439 taken whole + placebo solution + placebo chewed | Drug: PF-00345439<br>* 40 mg capsule swallowed whole, taken once<br>|
| Experimental: Treatment C<br>PF-00345439 chewed + placebo solution + placebo taken whole | Drug: PF-00345439<br>* 40 mg capsule chewed, taken once<br>|
| Active Comparator: Treatment D<br>Oxycodone HCl immediate-release 40 mg tablets (eg, 2 x 5 mg + 1 x 30 mg) + placebo taken whole + placebo chewed | Drug: oxycodone<br>* 40 mg solution, taken once<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug Liking: Peak Effect (Emax) | Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar visual analogue scale (VAS); where 0 mm = Not at all and 100 mm = Extremely. | 12 hours | 
| High: Peak Effect (Emax) | High assesses the degree that a subject feels a good effect (ie euphoria) at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar scale); where 0 mm = Not at all and 100 mm = Extremely. | 12 hours | 
| Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours | Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar visual analogue scale (VAS); where 0 mm = Not at all and 100 mm = Extremely. | 2 hours | 
| High: Area Under Effect Curve (AUE) From 0-2 Hours | High assesses the degree that a subject feels a good effect (ie euphoria) at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar scale); where 0 mm = Not at all and 100 mm = Extremely. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Take Drug Again Effect at 24 Hours | Take drug again visual analogue scale (VAS) is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = Definately not and score of 100 mm = Definately so). | 24 hours | 
| Overall Drug Liking | Overall Drug Liking visual analogue scale (VAS) is a subjective assessment of the degree to which a participant likes the drug overall. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = Not at all and 100 mm = Extremely). | 24 hours | 
| Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-1 Hour | Any drug effects effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1). | 1 hour | 
| Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour | Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1). | 1 hour | 
| Chewing Duration | Chewing duration is a measurement of the total time a person is able to chew. | 5 min | 
| Taste: Subjective Experience from Chewing | Subjective Experience from Chewing is a visual analogue scale (VAS) subjective assessment of the taste of the substance being chewed. Participants are asked to describe the taste of the drug using a VAS with score ranging from 0 mm to 100 mm (score of 0 mm = Extremely unpleasant, 50 mm = neutral, and 100 mm = Extremely pleasant). | 5 min | 
| Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-2 Hours | Any drug effects effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2). | 2 hours | 
| Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-3 Hours | Any drug effects effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-3) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-3). | 3 hours | 
| Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-12 Hours | Any drug effects effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12). | 12 hours | 
| Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours | Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2). | 2 hours | 
| Pupillometry: Area Under Effect Curve (AUE) From 0-3 Hours | Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-3) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-3). | 3 hours | 
| Pupillometry: Area Under Effect Curve (AUE) From 0-12 Hours | Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12). | 12 hours | 
| High: Area Under Effect Curve (AUE) From 0-1 Hour | High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1). | 1 hour | 
| High: Area Under Effect Curve (AUE) From 0-3 Hours | High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-3) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-3). | 3 hours | 
| High: Area Under Effect Curve (AUE) From 0-12 Hours | High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12). | 12 hours | 
| Good Drug Effects: Area Under Drug Effect Curve (AUE) From 0-1 Hour | Good drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1). | 1 hour | 
| Good Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours | Good drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2). | 2 hours | 
| Good Drug Effects: Area Under Effect Curve (AUE) From 0-3 Hours | Good drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-3) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-3). | 3 hours | 
| Good Drug Effects: Area Under Effect Curve (AUE) From 0-12 Hours | Good drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12). | 12 hours | 
| Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour | Bad drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1). | 1 hour | 
| Bad Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours | Bad drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2). | 2 hour | 
| Bad Drug Effects: Area Under Effect Curve (AUE) From 0-3 Hours | Bad drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-3) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-3). | 3 hours | 
| Bad Drug Effects: Area Under Effect Curve (AUE) From 0-12 Hours | Bad drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12). | 12 hours | 
| Feeling Sick: Area Under Effect Curve (AUE) From 0-1 Hour | Feeling sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1). | 1 hour | 
| Feeling Sick: Area Under Effect Curve (AUE) From 0-2 Hours | Feeling sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2). | 2 hours | 
| Feeling Sick: Area Under Effect Curve (AUE) From 0-3 Hours | Feeling sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-3) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-3). | 3 hours | 
| Feeling Sick: Area Under Effect Curve (AUE) From 0-12 Hours | Feeling sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12). | 12 hours | 
| Nausea: Area Under Effect Curve (AUE) From 0-1 Hour | Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1). | 1 hour | 
| Nausea: Area Under Effect Curve (AUE) From 0-2 Hours | Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2). | 2 hours | 
| Nausea: Area Under Effect Curve (AUE) From 0-3 Hours | Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-3) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-3). | 3 hours | 
| Nausea: Area Under Effect Curve (AUE) From 0-12 Hours | Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12). | 12 hours | 
| Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour | Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1). | 1 hour | 
| Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours | Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2). | 2 hours | 
| Sleepy: Area Under Effect Curve (AUE) From 0-3 Hours | Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-3) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-3). | 3 hours | 
| Sleepy: Area Under Effect Curve (AUE) From 0-12 Hour | Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12). | 12 hours | 
| Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour | Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1). | 1 hour | 
| Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours | Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2). | 2 hours | 
| Dizzy: Area Under Effect Curve (AUE) From 0-3 Hours | Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-3) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-3). | 3 hours | 
| Dizzy: Area Under Effect Curve (AUE) From 0-12 Hours | Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12). | 12 hours | 
| Bad Effects: Peak Effect (Emax) | Bad effects visual analogue scale (VAS) assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). | 12 hours | 
| Nausea: Peak Effect (Emax) | Nausea visual analogue scale (VAS) assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). | 12 hours | 
| Feel Sick: Peak Effect (Emax) | Feel sick visual analogue scale (VAS) assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). | 12 hours | 
| Sleepy: Peak Effect (Emax) | Sleepy visual analogue scale (VAS) assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). | 12 hours | 
| Dizzy: Peak Effect (Emax) | Dizzy visual analogue scale (VAS) assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). | 12 hours | 
| Pupillometry: Peak Effect (Emax) | Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. | 12 hours | 
| Good Drug Effects: Peak Effect (Emax) | Good drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12). | 12 hours | 
| Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour | Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar visual analogue scale (VAS), where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). | 1 hour | 
| Drug Liking: Area Under Effect Curve (AUE) From 0-3 Hours | Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar visual analogue scale (VAS), where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). | 3 hours | 
| Drug Liking: Area Under Effect Curve (AUE) From 0-12 Hours | Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar visual analogue scale (VAS), where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). | 12 hours | 
| Drug Liking: Time to Maximum (Peak) Effect (TEmax) | Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar visual analogue scale (VAS), where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). | 12 hours | 
| High: Time to Maximum (Peak) Effect (TEmax) | High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. | 12 hours | 
| Any Drug Effects: Time to Maximum (Peak) Effect (TEmax) | Any drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. | 12 hours | 
| Good Drug Effects: Time to Maximum (Peak) Effect (TEmax) | Good drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. | 12 hours | 
| Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax) | Bad drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. | 12 hours | 
| Feel Sick: Time to Maximum (Peak) Effect (TEmax) | Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. | 12 hours | 
| Nausea: Time to Maximum (Peak) Effect (TEmax) | Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. | 12 hours | 
| Sleepy: Time to Maximum (Peak) Effect (TEmax) | Sleepy visual analogue scale (VAS) assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). | 12 hours | 
| Dizzy: Time to Maximum (Peak) Effect (TEmax) | Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. | 12 hours | 
| Pupillometry: Time to Maximum (Peak) Effect (TEmax) | Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. TEmax = Time to maximum observed score. | 12 hours | 
| Any Drug Effects: Peak Effect (Emax) | Any drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). | 12 hours | 
| Texture: Subjective Experience from Chewing | Subjective Experience from Chewing is a visual analogue scale (VAS) subjective assessment of the texture of the substance being chewed. Participants are asked to describe the the texture of the drug using a VAS with score ranging from 0 mm to 100 mm (score of 0 mm = Extremely unpleasant, 50 mm = neutral, and 100 mm = Extremely pleasant). | 5 mins | 
| Maximum Observed Plasma Concentration (Cmax) |  | 24hr | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 24hr | 
| Area under the curve (AUC) |  | 24hr | 
| Systemic Clearance (CL) |  | 24hr | 
| volume of distribution (Vd) |  | 24hr | 
| Half-Life (t1/2) |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abuse potential, PF-00345439, drug abuse