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A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Users When ALO-02 Capsules Are Crushed and Snorted

This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Collaborator:
INC Research
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01775189
First received: January 22, 2013
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused when they are crushed and snorted.


Condition Intervention Phase
Healthy
 Drug: ALO-02 weight-matched placebo
Drug: crushed ALO-02 30 mg/3.6 mg
Drug: oxycodone weight-matched placebo
Drug: crushed oxycodone IR 30 mg
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Randomized, Double-Blind, Double-Dummy, Placebo Controlled, Single-Dose, 4-Way Crossover Study to Determine the Relative Abuse Potential of ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended Release Capsules) Compared to Oxycodone Immediate Release and Placebo When Administered Intranasally to Non-Dependent, Recreational Opioid Users

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • High: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ] [ Designated as safety issue: No ]
  • Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ] [ Designated as safety issue: No ]
  • High: Peak Effect (Emax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Drug Liking: Peak Effect (Emax) [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 0, 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
  • Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ] [ Designated as safety issue: No ]
  • Drug Liking: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • High: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
  • High: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ] [ Designated as safety issue: No ]
  • High: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Take Drug Again: Peak Effect (Emax) [ Time Frame: 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Take Drug Again: Mean Effect (Emean) [ Time Frame: 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Overall Drug Liking: Peak Effect (Emax) [ Time Frame: 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Overall Drug Liking: Mean Effect (Emean) [ Time Frame: 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h ] [ Designated as safety issue: No ]
  • Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
  • Good Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ] [ Designated as safety issue: No ]
  • Good Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ] [ Designated as safety issue: No ]
  • Good Drug Effects: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
  • Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ] [ Designated as safety issue: No ]
  • Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ] [ Designated as safety issue: No ]
  • Feel Sick: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Nausea: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
  • Nausea: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ] [ Designated as safety issue: No ]
  • Nausea: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ] [ Designated as safety issue: No ]
  • Nausea: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
  • Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ] [ Designated as safety issue: No ]
  • Sleepy: Area Under Effect Curve (AUE) From 0-8 Hour [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ] [ Designated as safety issue: No ]
  • Sleepy: Area Under Effect Curve (AUE) From 0-24 Hour [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
  • Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ] [ Designated as safety issue: No ]
  • Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ] [ Designated as safety issue: No ]
  • Dizzy: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects: Peak Effect (Emax) [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Good Drug Effects: Peak Effect (Emax) [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects: Peak Effect (Emax) [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Feel Sick: Peak Effect (Emax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Nausea: Peak Effect (Emax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Sleepy: Peak Effect (Emax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Dizzy: Peak Effect (Emax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour for "burning" [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: Yes ]
  • Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-2 Hours for "burning" [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ] [ Designated as safety issue: Yes ]
  • Subject Rating Scale for Nasal Effects: Peak Effect (Emax) for "burning" [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ] [ Designated as safety issue: Yes ]
  • Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) for "burning" [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ] [ Designated as safety issue: Yes ]
  • Percentage of dose (drug powder) insufflated [ Time Frame: up to 5 min post-dose ] [ Designated as safety issue: No ]
  • Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Pupillometry: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Pupillometry: Peak Effect (Emax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Pupillometry: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Drug Liking: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • High: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Good Drug Effects: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Sleepy: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Dizzy: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Nausea: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Feel Sick: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) of Oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) of Oxymorphone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) of Noroxycodone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) of Naltrexone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) of 6-beta-naltrexol [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxymorphone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of Noroxycodone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of 6-beta-naltrexol [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) of Oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) of Oxymorphone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) of Noroxycodone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) of Naltrexone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) of 6-beta-naltrexol [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the Oxycodone Concentration-Time Curve (AUC0-1h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the Oxymorphone Concentration-Time Curve (AUC0-1h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the Noroxycodone Concentration-Time Curve (AUC0-1h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the Naltrexone Concentration-Time Curve (AUC0-1h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-1h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the Oxycodone Concentration-Time Curve (AUC0-2h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the Oxymorphone Concentration-Time Curve (AUC0-2h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the Noroxycodone Concentration-Time Curve (AUC0-2h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the Naltrexone Concentration-Time Curve (AUC0-2h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-2h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the Oxycodone Concentration-Time Curve (AUC0-8h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the Oxymorphone Concentration-Time Curve (AUC0-8h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the Noroxycodone Concentration-Time Curve (AUC0-8h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the Naltrexone Concentration-Time Curve (AUC0-8h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-8h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable Oxycodone Concentration (AUClast) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable Oxymorphone Concentration (AUClast) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable Noroxycodone Concentration (AUClast) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable Naltrexone Concentration (AUClast) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable 6-beta-naltrexol Concentration (AUClast) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: February 2013
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Treatment A Drug: ALO-02 weight-matched placebo
crushed sugar spheres (powder) x 1 dose
Experimental: Treatment B Drug: crushed ALO-02 30 mg/3.6 mg
crushed ALO-02 30 mg/3.6 mg capsule x 1 dose
Placebo Comparator: Treatment C Drug: oxycodone weight-matched placebo
crushed lactose tablets (powder) x 1 dose
Active Comparator: Treatment D Drug: crushed oxycodone IR 30 mg
Three (3) crushed immediate-release (IR) oxycodone 10 mg tablets x 1 dose

Detailed Description:

Abuse Liability Study

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects
  • Non-dependent, recreational opioid users. (Must use opioid for non-therapeutic purposes on at least 10 occassions within the last year and at least once in the 8 weeks before Visit 1 (Screening Visit).
  • Must have experience with intranasal opioid administration (snorted opioid drugs on at least 3 occassions within the last year before Visit 1 (Screening Visit).

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775189

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
Canada, Ontario
Pfizer Investigational Site Recruiting
Toronto, Ontario, Canada, M5V 2T3
Sponsors and Collaborators
Pfizer
INC Research
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01775189     History of Changes
Other Study ID Numbers: B4531009
Study First Received: January 22, 2013
Last Updated: May 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Relative abuse potential study
Chronic pain
oxycodone
 naltrexone
opioid-related disorders
drug abusers

Additional relevant MeSH terms:
Naltrexone
Oxycodone
Analgesics, Opioid
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
 Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotics
Central Nervous System Depressants
Analgesics

ClinicalTrials.gov processed this record on May 23, 2013