HealthyPhase 1NCT01825447

A Study to Characterize the Abuse Liability of Intravenous Oxycodone Alone or in Combination With Intravenous Naltrexone in Healthy, Non-Dependent, Recreational Opioid Users

A Phase 1 study testing Oxycodone + Naltrexone and Oxycodone in people with Healthy, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main purpose of this study is to simulate if oxycodone and naltrexone combination capsules (ALO-02) were to be tampered with by dissolving and then injecting intravenously for the purpose of getting high. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Oxycodone + Naltrexone and Oxycodone
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 89 participants
Where: 1 siteUnited States
Study dates: Jul 2013to Sep 2013
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 subjects
Non-dependent, recreational opioid users
Must include at least one of these routes of administration: intranasal use on at least 3 occassions in the past year or intravenous use on at least 1 occasion in the past year before Screening (Visit 1).

Who cannot join

Diagnosis of substance and/or alcohol dependence
Subject has participated in, is currently participating in, or seeking treatment for substance and/or alcohol related disorder
History of sleep apnea.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer Investigational Site
Salt Lake City, Utah, 84106

Other trials in United States

About this study

Official title: A Randomized, Single-Dose, Placebo-Controlled, Double-Blind, 3-Way Crossover Study to Determine the Relative Abuse Potential of Intravenous Oxycodone Hydrochloride Alone or in Combination With Intravenous Naltrexone Hydrochloride in Opioid Experienced Non-Dependent Subjects

Conditions: Healthy
Being tested: Placebo, Oxycodone + Naltrexone, Oxycodone
Keywords: abuse potential, abuse liability, drug liking, oxycodone, naltrexone, intravenous, pharmacodynamic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
0.9% sodium chloride for injection x 1 dose administered intravenously (IV) push over 4 min.
Oxycodone + NaltrexoneDrug
Oxycodone hydrochloride (HCl) 20 mg IV and naltrexone HCl 2.4 mg IV administered simultaneously x 1 dose IV push over 4 min.
OxycodoneDrug
Oxycodone HCl 20 mg for injection x 1 dose IV push over 4 min.

Study groups in NCT01825447
Study group	Role	What they receive
Treatment A	Placebo comparator	Not described Receives: Drug: Placebo
Treatment B	Experimental	Not described Receives: Drug: Oxycodone + Naltrexone
Treatment C	Active comparator	Not described Receives: Drug: Oxycodone

What is being measured

The primary outcome is the main question the study is designed to answer.

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-point bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of
Measured: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Drug Liking: Peak Effect (Emax)
Measured: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
High: Area Under Effect Curve (AUE) From 0-2 Hours
High VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
High: Peak Effect (Emax)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

Secondary outcomes (95)

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-point bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of
Measured: 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours
Measured: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
High: Area Under Effect Curve (AUE) From 0-1 Hour
High VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
High: Area Under Effect Curve (AUE) From 0-8 Hours
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Take Drug Again: Peak Effect (Emax)
Take Drug Again 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-point bipolar VAS with score ranging from 0 mm to 100 (score of 0 =
Measured: 12, 24 h post-dose
Take Drug Again: Mean Effect (Emean)
Measured: 12, 24 h post-dose
Overall Drug Liking: Peak Effect (Emax)
Overall Drug Liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100-point VAS is used to assess response based on a score ranging from 0 to 100 (0 =
Measured: 12, 24 h post-dose
Overall Drug Liking: Mean Effect (Emean)
Measured: 12, 24 h post-dose
Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour
Any Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
Measured: 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Any Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours
Measured: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
Any Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours
Measured: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour
Good Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
Measured: 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Good Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours
Measured: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h
Good Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours
Measured: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
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-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
Measured: 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours
Measured: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours
Measured: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour
Feel Sick VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Nausea: Area Under Effect Curve (AUE) From 0-1 Hour
Nausea VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Nausea: Area Under Effect Curve (AUE) From 0-2 Hours
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
Nausea: Area Under Effect Curve (AUE) From 0-8 Hours
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour
Sleepy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
Sleepy: Area Under Effect Curve (AUE) From 0-8 Hours
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour
Dizzy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Any Drug Effects: Peak Effect (Emax)
Measured: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Good Drug Effects: Peak Effect (Emax)
Measured: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Bad Drug Effects: Peak Effect (Emax)
Measured: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Feel Sick: Peak Effect (Emax)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Nausea: Peak Effect (Emax)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Sleepy: Peak Effect (Emax)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Dizzy: Peak Effect (Emax)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
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 have the size of their pupil measured (in mm) using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions.
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Pupillometry: Peak Effect (Emax)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Pupillometry: Time to Maximum (Peak) Effect (TEmax)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Drug Liking: Time to Maximum (Peak) Effect (TEmax)
Measured: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
High: Time to Maximum (Peak) Effect (TEmax)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)
Measured: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)
Measured: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)
Measured: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Sleepy: Time to Maximum (Peak) Effect (TEmax)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Dizzy: Time to Maximum (Peak) Effect (TEmax)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Nausea: Time to Maximum (Peak) Effect (TEmax)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Feel Sick: Time to Maximum (Peak) Effect (TEmax)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Plasma Concentration of Oxycodone 5 Minutes Post-Dose (C5min)
Measured: pre-dose, 5 min post-dose
Plasma Concentration of Oxymorphone 5 Minutes Post-Dose (C5min)
Measured: pre-dose, 5 min post-dose
Plasma Concentration of Noroxycodone 5 Minutes Post-Dose (C5min)
Measured: pre-dose, 5 min post-dose
Plasma Concentration of Naltrexone 5 Minutes Post-Dose (C5min)
Measured: pre-dose, 5 min post-dose
Plasma Concentration of 6-beta-naltrexol 5 Minutes Post-Dose (C5min)
Measured: pre-dose, 5 min post-dose
Plasma Decay Half-Life (t1/2) of Oxycodone
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Plasma Decay Half-Life (t1/2) of Oxymorphone
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Plasma Decay Half-Life (t1/2) of Noroxycodone
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Plasma Decay Half-Life (t1/2) of Naltrexone
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Plasma Decay Half-Life (t1/2) of 6-beta-naltrexol
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Oxycodone Concentration-Time Curve (AUC0-1h)
AUC is a measure of the plasma concentration of the drug over time.
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Oxymorphone Concentration-Time Curve (AUC0-1h)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Noroxycodone Concentration-Time Curve (AUC0-1h)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Naltrexone Concentration-Time Curve (AUC0-1h)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-1h)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Oxycodone Concentration-Time Curve (AUC0-2h)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Oxymorphone Concentration-Time Curve (AUC0-2h)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Noroxycodone Concentration-Time Curve (AUC0-2h)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Naltrexone Concentration-Time Curve (AUC0-2h)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-2h)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Oxycodone Concentration-Time Curve (AUC0-8h)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Oxymorphone Concentration-Time Curve (AUC0-8h)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Noroxycodone Concentration-Time Curve (AUC0-8h)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Naltrexone Concentration-Time Curve (AUC0-8h)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-8h)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Curve From Time Zero to Last Quantifiable Oxycodone Concentration (AUClast)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Curve From Time Zero to Last Quantifiable Oxymorphone Concentration (AUClast)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Curve From Time Zero to Last Quantifiable Noroxycodone Concentration (AUClast)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Curve From Time Zero to Last Quantifiable Naltrexone Concentration (AUClast)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Curve From Time Zero to Last Quantifiable 6-beta-naltrexol Concentration (AUClast)
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Oxycodone
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Oxymorphone
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Noroxycodone
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Naltrexone
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for 6-beta-naltrexol
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Systemic Clearance (Cl) of Oxycodone
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Systemic Clearance (Cl) of Oxymorphone
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Systemic Clearance (Cl) of Noroxycodone
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Systemic Clearance (Cl) of Naltrexone
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Systemic Clearance (Cl) of 6-beta-naltrexol
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Volume of Distribution at Steady State (Vss) for Oxycodone
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Volume of Distribution at Steady State (Vss) for Oxymorphone
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Volume of Distribution at Steady State (Vss) for Noroxycodone
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Volume of Distribution at Steady State (Vss) for Naltrexone
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Volume of Distribution at Steady State (Vss) for 6-beta-naltrexol
Measured: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Sep 2013

First posted5 Apr 2013 (estimated)
Study startJul 2013
Primary completionSep 2013
Study completionSep 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
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: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01825447
Sponsor's protocol ID: B4981002
Status last verified: Oct 2013
First submitted: 2 Apr 2013
Last updated: 8 Oct 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Single-Dose, Placebo-Controlled, Double-Blind, 3-Way Crossover Study to Determine the Relative Abuse Potential of Intravenous Oxycodone Hydrochloride Alone or in Combination With Intravenous Naltrexone Hydrochloride in Opioid Experienced Non-Dependent Subjects
ClinicalTrials.gov ID: NCT01825447
Acronym / sponsor ID: B4981002
Conditions: Healthy
Keywords: abuse potential, abuse liability, drug liking, oxycodone, naltrexone, intravenous, pharmacodynamic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: Lifetree Clinical Research Center, Salt Lake City, Utah
Study start: Jul 2013
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 5 Apr 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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Treatment A	Placebo comparator	Drug: Placebo
Treatment B	Experimental	Drug: Oxycodone + Naltrexone
Treatment C	Active comparator	Drug: Oxycodone

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy subjects
Non-dependent, recreational opioid users
Must include at least one of these routes of administration: intranasal use on at least 3 occassions in the past year or intravenous use on at least 1 occasion in the past year before Screening (Visit 1).

Key exclusion criteria (3 listed)

Diagnosis of substance and/or alcohol dependence
Subject has participated in, is currently participating in, or seeking treatment for substance and/or alcohol related disorder
History of sleep apnea.

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
Placebo0.9% sodium chloride for injection x 1 dose administered intravenously (IV) push over 4 min.	Drug	Treatment A
Oxycodone + NaltrexoneOxycodone hydrochloride (HCl) 20 mg IV and naltrexone HCl 2.4 mg IV administered simultaneously x 1 dose IV push over 4 min.	Drug	Treatment B
OxycodoneOxycodone HCl 20 mg for injection x 1 dose IV push over 4 min.	Drug	Treatment C

Primary outcome

Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours
Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
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-point bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of
Drug Liking: Peak Effect (Emax)
Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
High: Area Under Effect Curve (AUE) From 0-2 Hours
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
High VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
High: Peak Effect (Emax)
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

95 secondary outcomes

Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour
Time frame: 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours
Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
High: Area Under Effect Curve (AUE) From 0-1 Hour
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
High: Area Under Effect Curve (AUE) From 0-8 Hours
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Take Drug Again: Peak Effect (Emax)
Time frame: 12, 24 h post-dose
Take Drug Again: Mean Effect (Emean)
Time frame: 12, 24 h post-dose
Overall Drug Liking: Peak Effect (Emax)
Time frame: 12, 24 h post-dose
Overall Drug Liking: Mean Effect (Emean)
Time frame: 12, 24 h post-dose
Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour
Time frame: 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Any Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours
Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
Any Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours
Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour
Time frame: 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Good Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours
Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h
Good Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours
Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour
Time frame: 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours
Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours
Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Nausea: Area Under Effect Curve (AUE) From 0-1 Hour
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Nausea: Area Under Effect Curve (AUE) From 0-2 Hours
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
Nausea: Area Under Effect Curve (AUE) From 0-8 Hours
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
Sleepy: Area Under Effect Curve (AUE) From 0-8 Hours
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Any Drug Effects: Peak Effect (Emax)
Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Good Drug Effects: Peak Effect (Emax)
Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Bad Drug Effects: Peak Effect (Emax)
Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Feel Sick: Peak Effect (Emax)
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Nausea: Peak Effect (Emax)
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Sleepy: Peak Effect (Emax)
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Dizzy: Peak Effect (Emax)
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Pupillometry: Peak Effect (Emax)
Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

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 8 Oct 2013.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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 Oxycodone + Naltrexone and Oxycodone in people with Healthy, run by Pfizer 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 3 inclusion and 3 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 8 Oct 2013. 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: Area Under Effect Curve (AUE) From 0-2 Hours (time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose). 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?

On the ClinicalTrials.gov record for NCT01825447.

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 8 Oct 2013.