Lifetree Clinical Research
Salt Lake City, Utah, 84106, United States
NCT Number: NCT01986283
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Salt Lake City, Utah, 84106, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Taken once
40 mg capsule swallowed whole, taken once
40 mg solution, taken once
Time frame: 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 0 mm = Not at all and 100 mm = Extremely.
Time frame: 12 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 24 hours
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).
Time frame: 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).
Time frame: 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).
Time frame: 5 min
Chewing duration is a measurement of the total time a person is able to chew.
Time frame: 5 min
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 2 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 (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 12 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 (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 12 hours
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).
Time frame: 12 hours
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).
Time frame: 12 hours
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).
Time frame: 12 hours
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).
Time frame: 12 hours
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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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). TEmax = Time to maximum observed score.
Time frame: 12 hours
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.
Time frame: 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). TEmax = Time to maximum observed score.
Time frame: 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). TEmax = Time to maximum observed score.
Time frame: 12 hours
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.
Time frame: 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). TEmax = Time to maximum observed score.
Time frame: 12 hours
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).
Time frame: 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). TEmax = Time to maximum observed score.
Time frame: 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. TEmax = Time to maximum observed score.
Time frame: 12 hours
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).
Time frame: 5 mins
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).
Time frame: 24hr
Time frame: 24hr
Time frame: 24hr
Time frame: 24hr
Time frame: 24hr
Time frame: 24 hours
Pain Therapeutics
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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