Clinical trial NCT01825447: A Study to Characterize the Abuse Liability of Intravenous Oxycodone Alone or in Combination With Intravenous Naltrexone in Healthy, Non-Dependent, Recreational Opioid Users
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: abuse potential
abuse liability
drug liking
oxycodone
naltrexone
intravenous
pharmacodynamic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Lifetree Clinical Research Center, Salt Lake City, Utah
First posted: 2013-04-05
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours
timeFrame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Drug Liking: Peak Effect (Emax)
timeFrame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: High: Area Under Effect Curve (AUE) From 0-2 Hours
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: High: Peak Effect (Emax)
timeFrame: 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:
measure: Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour
timeFrame: 5 min, 15 min, 30 min, 45 min, 1 h post-dose
measure: Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours
timeFrame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
measure: High: Area Under Effect Curve (AUE) From 0-1 Hour
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
measure: High: Area Under Effect Curve (AUE) From 0-8 Hours
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
measure: Take Drug Again: Peak Effect (Emax)
timeFrame: 12, 24 h post-dose
measure: Take Drug Again: Mean Effect (Emean)
timeFrame: 12, 24 h post-dose
measure: Overall Drug Liking: Peak Effect (Emax)
timeFrame: 12, 24 h post-dose
measure: Overall Drug Liking: Mean Effect (Emean)
timeFrame: 12, 24 h post-dose
measure: Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour
timeFrame: 5 min, 15 min, 30 min, 45 min, 1 h post-dose
measure: Any Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours
timeFrame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
measure: Any Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours
timeFrame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
measure: Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour
timeFrame: 5 min, 15 min, 30 min, 45 min, 1 h post-dose
measure: Good Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours
timeFrame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h
measure: Good Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours
timeFrame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
measure: Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour
timeFrame: 5 min, 15 min, 30 min, 45 min, 1 h post-dose
measure: Bad Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours
timeFrame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h
measure: Bad Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours
timeFrame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
measure: Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
measure: Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
measure: Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
measure: Nausea: Area Under Effect Curve (AUE) From 0-1 Hour
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
measure: Nausea: Area Under Effect Curve (AUE) From 0-2 Hours
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
measure: Nausea: Area Under Effect Curve (AUE) From 0-8 Hours
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
measure: Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
measure: Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
measure: Sleepy: Area Under Effect Curve (AUE) From 0-8 Hours
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
measure: Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
measure: Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
measure: Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
measure: Any Drug Effects: Peak Effect (Emax)
timeFrame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Good Drug Effects: Peak Effect (Emax)
timeFrame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Bad Drug Effects: Peak Effect (Emax)
timeFrame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Feel Sick: Peak Effect (Emax)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Nausea: Peak Effect (Emax)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Sleepy: Peak Effect (Emax)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Dizzy: Peak Effect (Emax)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
measure: Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
measure: Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
measure: Pupillometry: Peak Effect (Emax)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Pupillometry: Time to Maximum (Peak) Effect (TEmax)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Drug Liking: Time to Maximum (Peak) Effect (TEmax)
timeFrame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: High: Time to Maximum (Peak) Effect (TEmax)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)
timeFrame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)
timeFrame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)
timeFrame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Sleepy: Time to Maximum (Peak) Effect (TEmax)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Dizzy: Time to Maximum (Peak) Effect (TEmax)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Nausea: Time to Maximum (Peak) Effect (TEmax)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Feel Sick: Time to Maximum (Peak) Effect (TEmax)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Plasma Concentration of Oxycodone 5 Minutes Post-Dose (C5min)
timeFrame: pre-dose, 5 min post-dose
measure: Plasma Concentration of Oxymorphone 5 Minutes Post-Dose (C5min)
timeFrame: pre-dose, 5 min post-dose
measure: Plasma Concentration of Noroxycodone 5 Minutes Post-Dose (C5min)
timeFrame: pre-dose, 5 min post-dose
measure: Plasma Concentration of Naltrexone 5 Minutes Post-Dose (C5min)
timeFrame: pre-dose, 5 min post-dose
measure: Plasma Concentration of 6-beta-naltrexol 5 Minutes Post-Dose (C5min)
timeFrame: pre-dose, 5 min post-dose
measure: Plasma Decay Half-Life (t1/2) of Oxycodone
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Plasma Decay Half-Life (t1/2) of Oxymorphone
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Plasma Decay Half-Life (t1/2) of Noroxycodone
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Plasma Decay Half-Life (t1/2) of Naltrexone
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Plasma Decay Half-Life (t1/2) of 6-beta-naltrexol
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the Oxycodone Concentration-Time Curve (AUC0-1h)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the Oxymorphone Concentration-Time Curve (AUC0-1h)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the Noroxycodone Concentration-Time Curve (AUC0-1h)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the Naltrexone Concentration-Time Curve (AUC0-1h)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-1h)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the Oxycodone Concentration-Time Curve (AUC0-2h)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the Oxymorphone Concentration-Time Curve (AUC0-2h)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the Noroxycodone Concentration-Time Curve (AUC0-2h)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the Naltrexone Concentration-Time Curve (AUC0-2h)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-2h)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the Oxycodone Concentration-Time Curve (AUC0-8h)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the Oxymorphone Concentration-Time Curve (AUC0-8h)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the Noroxycodone Concentration-Time Curve (AUC0-8h)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the Naltrexone Concentration-Time Curve (AUC0-8h)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-8h)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Oxycodone Concentration (AUClast)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Oxymorphone Concentration (AUClast)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Noroxycodone Concentration (AUClast)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Naltrexone Concentration (AUClast)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the Curve From Time Zero to Last Quantifiable 6-beta-naltrexol Concentration (AUClast)
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Oxycodone
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Oxymorphone
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Noroxycodone
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Naltrexone
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for 6-beta-naltrexol
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Systemic Clearance (Cl) of Oxycodone
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Systemic Clearance (Cl) of Oxymorphone
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Systemic Clearance (Cl) of Noroxycodone
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Systemic Clearance (Cl) of Naltrexone
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Systemic Clearance (Cl) of 6-beta-naltrexol
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Volume of Distribution at Steady State (Vss) for Oxycodone
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Volume of Distribution at Steady State (Vss) for Oxymorphone
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Volume of Distribution at Steady State (Vss) for Noroxycodone
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Volume of Distribution at Steady State (Vss) for Naltrexone
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
measure: Volume of Distribution at Steady State (Vss) for 6-beta-naltrexol
timeFrame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: