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Clinical Trials/NCT01825447
NCT01825447CompletedPhase 1

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

Pfizer1 site in 1 country89 target enrollmentStarted: July 2013Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Pfizer
Enrollment
89
Locations
1
Primary Endpoint
High: Area Under Effect Curve (AUE) From 0-2 Hours
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Treatment A

Placebo Comparator

Intervention: Placebo (Drug)

Treatment B

Experimental

Intervention: Oxycodone + Naltrexone (Drug)

Treatment C

Active Comparator

Intervention: Oxycodone (Drug)

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)(5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose)
  • Take Drug Again: Mean Effect (Emean)(12, 24 h post-dose)
  • Overall Drug Liking: Peak Effect (Emax)(12, 24 h post-dose)
  • Overall Drug Liking: Mean Effect (Emean)(12, 24 h post-dose)
  • Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour(5 min, 15 min, 30 min, 45 min, 1 h post-dose)
  • Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour(5 min, 15 min, 30 min, 45 min, 1 h post-dose)
  • Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours(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(pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose)
  • High: Area Under Effect Curve (AUE) From 0-8 Hours(pre-dose, 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 0-8 Hours(pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose)
  • Nausea: Time to Maximum (Peak) Effect (TEmax)(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)(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)(pre-dose, 5 min post-dose)
  • Plasma Concentration of Oxymorphone 5 Minutes Post-Dose (C5min)(pre-dose, 5 min post-dose)
  • Plasma Concentration of Noroxycodone 5 Minutes Post-Dose (C5min)(pre-dose, 5 min post-dose)
  • Plasma Concentration of Naltrexone 5 Minutes Post-Dose (C5min)(pre-dose, 5 min post-dose)
  • Plasma Concentration of 6-beta-naltrexol 5 Minutes Post-Dose (C5min)(pre-dose, 5 min post-dose)
  • Plasma Decay Half-Life (t1/2) of Oxycodone(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(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(pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose)
  • Take Drug Again: Peak Effect (Emax)(12, 24 h post-dose)
  • Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour(5 min, 15 min, 30 min, 45 min, 1 h post-dose)
  • Good Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours(5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h)
  • Any Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours(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(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(pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose)
  • Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours(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(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)(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)(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)(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)(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)(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)(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)(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(pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose)
  • Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours(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(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)(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)(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)(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)(pre-dose, 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)(5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose)
  • Good Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours(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(5 min, 15 min, 30 min, 45 min, 1 h post-dose)
  • Bad Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours(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(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(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(pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose)
  • Nausea: Area Under Effect Curve (AUE) From 0-1 Hour(pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose)
  • Nausea: Area Under Effect Curve (AUE) From 0-2 Hours(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(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(pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose)
  • Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours(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(pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose)
  • Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)(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(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(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(pre-dose, 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)(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)(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(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(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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(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(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(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(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(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(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(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(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(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(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(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(pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose)

Investigators

Sponsor
Pfizer
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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