Opioid UsersPhase 1NCT01986283
Abuse Potential Study of PF-00345439
A Phase 1 study testing Capsule, PF-00345439 and oxycodone in people with Opioid Users, run by Pain Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Users
- What is being tested?
- Capsule, PF-00345439 and oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Aug 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Lifetree Clinical Research
Salt Lake City, Utah, 84106
About this study
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
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.
- Conditions
- Opioid Users
- Being tested
- Capsule, PF-00345439, oxycodone
- Keywords
- Abuse potential, PF-00345439, drug abuse
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsuleDrug
Taken once
PF-00345439Drug
40 mg capsule swallowed whole, taken once
PF-00345439Drug
40 mg capsule chewed, taken once
oxycodoneDrug
40 mg solution, taken once
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Placebo comparator | Placebo solution +placebo capsule + placebo capsule chewed. Receives: Drug: Capsule |
| Treatment B | Experimental | PF-00345439 taken whole + placebo solution + placebo chewed Receives: Drug: PF-00345439 |
| Treatment C | Experimental | PF-00345439 chewed + placebo solution + placebo taken whole Receives: Drug: PF-00345439 |
| Treatment D | Active comparator | Oxycodone HCl immediate-release 40 mg tablets (eg, 2 x 5 mg + 1 x 30 mg) + placebo taken whole + placebo chewed Receives: Drug: oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 hours
Secondary outcomes (67)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 1 hour
Chewing Duration
Chewing duration is a measurement of the total time a person is able to chew.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 5 mins
Maximum Observed Plasma Concentration (Cmax)
Measured: 24hr
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 24hr
Area under the curve (AUC)
Measured: 24hr
Systemic Clearance (CL)
Measured: 24hr
volume of distribution (Vd)
Measured: 24hr
Half-Life (t1/2)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UsersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pain Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986283
- Sponsor's protocol ID
- B4501016
- Status last verified
- Mar 2016
- First submitted
- 1 Nov 2013
- Last updated
- 4 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01986283
- Acronym / sponsor ID
- B4501016
- Conditions
- Opioid Users
- Keywords
- Abuse potential, PF-00345439, drug abuse
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Pain TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 18 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Placebo comparator | Drug: CapsulePlacebo solution +placebo capsule + placebo capsule chewed. |
| Treatment B | Experimental | Drug: PF-00345439PF-00345439 taken whole + placebo solution + placebo chewed |
| Treatment C | Experimental | Drug: PF-00345439PF-00345439 chewed + placebo solution + placebo taken whole |
| Treatment D | Active comparator | Drug: oxycodoneOxycodone HCl immediate-release 40 mg tablets (eg, 2 x 5 mg + 1 x 30 mg) + placebo taken whole + placebo chewed |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapsuleTaken once | Drug | Treatment A |
| PF-0034543940 mg capsule swallowed whole, taken once | Drug | Treatment B |
| PF-0034543940 mg capsule chewed, taken once | Drug | Treatment C |
| oxycodone40 mg solution, taken once | Drug | Treatment D |
Primary outcome
Drug Liking: Peak Effect (Emax)
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.
High: Peak Effect (Emax)
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.
Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours
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.
High: Area Under Effect Curve (AUE) From 0-2 Hours
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.
67 secondary outcomes
Take Drug Again Effect at 24 Hours
Time frame: 24 hours
Overall Drug Liking
Time frame: 24 hours
Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-1 Hour
Time frame: 1 hour
Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour
Time frame: 1 hour
Chewing Duration
Time frame: 5 min
Taste: Subjective Experience from Chewing
Time frame: 5 min
Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-2 Hours
Time frame: 2 hours
Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-3 Hours
Time frame: 3 hours
Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-12 Hours
Time frame: 12 hours
Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours
Time frame: 2 hours
Pupillometry: Area Under Effect Curve (AUE) From 0-3 Hours
Time frame: 3 hours
Pupillometry: Area Under Effect Curve (AUE) From 0-12 Hours
Time frame: 12 hours
High: Area Under Effect Curve (AUE) From 0-1 Hour
Time frame: 1 hour
High: Area Under Effect Curve (AUE) From 0-3 Hours
Time frame: 3 hours
High: Area Under Effect Curve (AUE) From 0-12 Hours
Time frame: 12 hours
Good Drug Effects: Area Under Drug Effect Curve (AUE) From 0-1 Hour
Time frame: 1 hour
Good Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours
Time frame: 2 hours
Good Drug Effects: Area Under Effect Curve (AUE) From 0-3 Hours
Time frame: 3 hours
Good Drug Effects: Area Under Effect Curve (AUE) From 0-12 Hours
Time frame: 12 hours
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour
Time frame: 1 hour
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours
Time frame: 2 hour
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-3 Hours
Time frame: 3 hours
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-12 Hours
Time frame: 12 hours
Feeling Sick: Area Under Effect Curve (AUE) From 0-1 Hour
Time frame: 1 hour
Feeling Sick: Area Under Effect Curve (AUE) From 0-2 Hours
Time frame: 2 hours
Feeling Sick: Area Under Effect Curve (AUE) From 0-3 Hours
Time frame: 3 hours
Feeling Sick: Area Under Effect Curve (AUE) From 0-12 Hours
Time frame: 12 hours
Nausea: Area Under Effect Curve (AUE) From 0-1 Hour
Time frame: 1 hour
Nausea: Area Under Effect Curve (AUE) From 0-2 Hours
Time frame: 2 hours
Nausea: Area Under Effect Curve (AUE) From 0-3 Hours
Time frame: 3 hours
Nausea: Area Under Effect Curve (AUE) From 0-12 Hours
Time frame: 12 hours
Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour
Time frame: 1 hour
Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours
Time frame: 2 hours
Sleepy: Area Under Effect Curve (AUE) From 0-3 Hours
Time frame: 3 hours
Sleepy: Area Under Effect Curve (AUE) From 0-12 Hour
Time frame: 12 hours
Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour
Time frame: 1 hour
Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours
Time frame: 2 hours
Dizzy: Area Under Effect Curve (AUE) From 0-3 Hours
Time frame: 3 hours
Dizzy: Area Under Effect Curve (AUE) From 0-12 Hours
Time frame: 12 hours
Bad Effects: Peak Effect (Emax)
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Opioid Users
Enrolling by invitation
SpinePal Open Pilot
Spine Surgery
RecruitingPhase 4
Abuse Potential of Gabapentin Taken Orally Concomitantly With Oxycodone Hydrochloride in Healthy, Non-Drug-Dependent, Recreational Opioid Users
Healthy
RecruitingObservational study
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Opioid-induced Constipation
Enrolling by invitationObservational study
Effects of Mental Tasks on Breathing Patterns in Adults Using Chronic Opioids vs Non-opioid Users.
Opiod Use Disorder, Obstructive Sleep Apnea
RecruitingObservational study
Biopsychosocial Markers of Addiction in Opioid Users: an Integrated Approach
Opioid Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Capsule, PF-00345439 and oxycodone in people with Opioid Users, run by Pain Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug Liking: Peak Effect (Emax) (time frame: 12 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2016.