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A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers

This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Collaborator:
INC Research
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01746901
First received: December 7, 2012
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.


Condition Intervention Phase
Healthy
 Drug: Placebo
Drug: intact ALO-02 60 mg/7.2 mg
Drug: crushed ALO-02 60 mg/7.2 mg
Drug: crushed oxycodone IR 60 mg
Drug: crushed ALO-02 40 mg/4.8 mg
Drug: crushed oxycodone IR 40 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, 6-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 Orally 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:
  • Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0, 2 h post-dose ] [ Designated as safety issue: No ]
  • High: Peak Effect (Emax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 h post-dose ] [ Designated as safety issue: No ]
  • Drug Liking: Peak Effect (Emax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 h post-dose ] [ Designated as safety issue: No ]
  • High: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: pre-dose, 2 h post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum Observed Plasma Concentration (Cmax) of oxymorphone [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) of noroxycodone [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects: Peak Effect (Emax) [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
  • Nausea: Peak Effect (Emax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
  • Feel Sick: Peak Effect (Emax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
  • Sleepy: Peak Effect (Emax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
  • Dizzy: Peak Effect (Emax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
  • Pupillometry: Peak Effect (Emax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
  • Good Drug Effects: Peak Effect (Emax) [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects: Peak Effect (Emax) [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) of oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 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, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
  • Area under the Concentration-Time Curve (AUC0-1h) for oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 1 h post-dose ] [ Designated as safety issue: No ]
  • Area under the Concentration-Time Curve (AUC0-2h) for oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2 h post-dose ] [ Designated as safety issue: No ]
  • Area under the Concentration-Time Curve (AUC0-8h) for oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 h post-dose ] [ Designated as safety issue: No ]
  • Area under the Concentration-Time Curve (AUC0-12h) for oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 h post-dose ] [ Designated as safety issue: No ]
  • Area under the Concentration-Time Curve (AUC0-24h) for oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24 h post-dose ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) for oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
  • Drug Liking: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 h post-dose ] [ Designated as safety issue: No ]
  • High: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 h post-dose ] [ Designated as safety issue: No ]
  • Good Effects: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 h post-dose ] [ Designated as safety issue: No ]
  • Any Effects: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 h post-dose ] [ Designated as safety issue: No ]
  • Bad Effects: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 h post-dose ] [ Designated as safety issue: No ]
  • Nausea: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 h post-dose ] [ Designated as safety issue: No ]
  • Feel Sick: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 h post-dose ] [ Designated as safety issue: No ]
  • Sleepy: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 h post-dose ] [ Designated as safety issue: No ]
  • Dizzy: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 h post-dose ] [ Designated as safety issue: No ]
  • Pupillometry: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 h post-dose ] [ Designated as safety issue: No ]
  • Take Drug Again: Peak Effect (Emax) [ Time Frame: 12, 24, 36 h post-dose ] [ Designated as safety issue: No ]
  • Take Drug Again: Mean Effect (Emean) [ Time Frame: 12, 24, 36 h post-dose ] [ Designated as safety issue: No ]
  • Take Drug Again: Minimum Effect (Emin) [ Time Frame: 12, 24, 36 h post-dose ] [ Designated as safety issue: No ]
  • Overall Drug Liking: Peak Effect (Emax) [ Time Frame: 12, 24, 36 h post-dose ] [ Designated as safety issue: No ]
  • Overall Drug Liking: Minimum Effect (Emin) [ Time Frame: 12, 24, 36 h post-dose ] [ Designated as safety issue: No ]
  • Overall Drug Liking: Mean Effect (Emean) [ Time Frame: 12, 24, 36 h post-dose ] [ Designated as safety issue: No ]
  • Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hours [ Time Frame: 0, 1 h post-dose ] [ Designated as safety issue: No ]
  • High: Area Under Effect Curve (AUE) From 0-1 Hours [ Time Frame: 0, 1 h post-dose ] [ Designated as safety issue: No ]
  • Bad Effects: Area Under Effect Curve (AUE) From 0-1 Hours [ Time Frame: 0, 1 h post-dose ] [ Designated as safety issue: No ]
  • Nausea: Area Under Effect Curve (AUE) From 0-1 Hours [ Time Frame: pre-dose, 1 h post-dose ] [ Designated as safety issue: No ]
  • Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hours [ Time Frame: pre-dose, 1 h post-dose ] [ Designated as safety issue: No ]
  • Sleepy: Area Under Effect Curve (AUE) From 0-1 Hours [ Time Frame: pre-dose, 1 h post-dose ] [ Designated as safety issue: No ]
  • Dizzy: Area Under Effect Curve (AUE) From 0-1 Hours [ Time Frame: pre-dose, 1 h post-dose ] [ Designated as safety issue: No ]
  • Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hours [ Time Frame: 0, 1 h post-dose ] [ Designated as safety issue: No ]
  • Good Effects: Area Under Effect Curve (AUE) From 0-1 Hours [ Time Frame: 0, 1 h post-dose ] [ Designated as safety issue: No ]
  • Any Effects: Area Under Effect Curve (AUE) From 0-1 Hours [ Time Frame: 0, 1 h post-dose ] [ Designated as safety issue: No ]
  • Bad Effects: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0, 2 h post-dose ] [ Designated as safety issue: No ]
  • Nausea: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: pre-dose, 2 h post-dose ] [ Designated as safety issue: No ]
  • Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: pre-dose, 2 h post-dose ] [ Designated as safety issue: No ]
  • Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: pre-dose, 2 h post-dose ] [ Designated as safety issue: No ]
  • Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: pre-dose, 2 h post-dose ] [ Designated as safety issue: No ]
  • Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0, 2 h post-dose ] [ Designated as safety issue: No ]
  • Good Effects: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0, 2 h post-dose ] [ Designated as safety issue: No ]
  • Any Effects: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0, 2 h post-dose ] [ Designated as safety issue: No ]
  • Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0, 8 h post-dose ] [ Designated as safety issue: No ]
  • Drug Liking: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 0, 12 h post-dose ] [ Designated as safety issue: No ]
  • Drug Liking: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0, 24 h post-dose ] [ Designated as safety issue: No ]
  • Drug Liking: Area Under Effect Curve (AUE) From 0-36 Hours [ Time Frame: 0, 36 h post-dose ] [ Designated as safety issue: No ]
  • High: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: pre-dose, 8 h post-dose ] [ Designated as safety issue: No ]
  • High: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: pre-dose, 12 h post-dose ] [ Designated as safety issue: No ]
  • High: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: pre-dose, 24 h post-dose ] [ Designated as safety issue: No ]
  • High: Area Under Effect Curve (AUE) From 0-36 Hours [ Time Frame: pre-dose, 36 h post-dose ] [ Designated as safety issue: No ]
  • Any Effects: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0, 8 h post-dose ] [ Designated as safety issue: No ]
  • Any Effects: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 0, 12 h post-dose ] [ Designated as safety issue: No ]
  • Any Effects: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0, 24 h post-dose ] [ Designated as safety issue: No ]
  • Any Effects: Area Under Effect Curve (AUE) From 0-36 Hours [ Time Frame: 0, 36 h post-dose ] [ Designated as safety issue: No ]
  • Good Effects: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0, 8 h post-dose ] [ Designated as safety issue: No ]
  • Good Effects: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 0, 12 h post-dose ] [ Designated as safety issue: No ]
  • Good Effects: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0, 24 h post-dose ] [ Designated as safety issue: No ]
  • Good Effects: Area Under Effect Curve (AUE) From 0-36 Hours [ Time Frame: 0, 36 h post-dose ] [ Designated as safety issue: No ]
  • Bad Effects: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0, 8 h post-dose ] [ Designated as safety issue: No ]
  • Bad Effects: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 0, 12 h post-dose ] [ Designated as safety issue: No ]
  • Bad Effects: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0, 24 h post-dose ] [ Designated as safety issue: No ]
  • Bad Effects: Area Under Effect Curve (AUE) From 0-36 Hours [ Time Frame: 0, 36 h post-dose ] [ Designated as safety issue: No ]
  • Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: pre-dose, 8 h post-dose ] [ Designated as safety issue: No ]
  • Feel Sick: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: pre-dose, 12 h post-dose ] [ Designated as safety issue: No ]
  • Feel Sick: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: pre-dose, 24 h post-dose ] [ Designated as safety issue: No ]
  • Feel Sick: Area Under Effect Curve (AUE) From 0-36 Hours [ Time Frame: pre-dose, 36 h post-dose ] [ Designated as safety issue: No ]
  • Nausea: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: pre-dose, 8 h post-dose ] [ Designated as safety issue: No ]
  • Nausea: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: pre-dose, 12 h post-dose ] [ Designated as safety issue: No ]
  • Nausea: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: pre-dose, 24 h post-dose ] [ Designated as safety issue: No ]
  • Nausea: Area Under Effect Curve (AUE) From 0-36 Hours [ Time Frame: pre-dose, 36 h post-dose ] [ Designated as safety issue: No ]
  • Sleepy: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: pre-dose, 8 h post-dose ] [ Designated as safety issue: No ]
  • Sleepy: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: pre-dose, 12 h post-dose ] [ Designated as safety issue: No ]
  • Sleepy: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: pre-dose, 24 h post-dose ] [ Designated as safety issue: No ]
  • Sleepy: Area Under Effect Curve (AUE) From 0-36 Hours [ Time Frame: pre-dose, 36 h post-dose ] [ Designated as safety issue: No ]
  • Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: pre-dose, 8 h post-dose ] [ Designated as safety issue: No ]
  • Dizzy: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: pre-dose, 12 h post-dose ] [ Designated as safety issue: No ]
  • Dizzy: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: pre-dose, 24 h post-dose ] [ Designated as safety issue: No ]
  • Dizzy: Area Under Effect Curve (AUE) From 0-36 Hours [ Time Frame: pre-dose, 36 h post-dose ] [ Designated as safety issue: No ]
  • Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0, 8 h post-dose ] [ Designated as safety issue: No ]
  • Pupillometry: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 0, 12 h post-dose ] [ Designated as safety issue: No ]
  • Pupillometry: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0, 24 h post-dose ] [ Designated as safety issue: No ]
  • Pupillometry: Area Under Effect Curve (AUE) From 0-36 Hours [ Time Frame: 0, 36 h post-dose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) of naltrexone [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 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, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 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, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 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, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 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, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 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, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2013
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Treatment A Drug: Placebo
Placebo solution + Placebo ALO-02 (intact)
Experimental: Treatment B Drug: intact ALO-02 60 mg/7.2 mg
Placebo solution + ALO-02 60 mg/7.2 mg (intact)
Experimental: Treatment C Drug: crushed ALO-02 60 mg/7.2 mg
crushed ALO-02 60 mg/7.2 mg in solution + placebo ALO-02 (intact)
Active Comparator: Treatment D Drug: crushed oxycodone IR 60 mg
crushed oxycodone immediate-release (IR) 60 mg in solution + placebo ALO-02 (intact)
Experimental: Treatment E Drug: crushed ALO-02 40 mg/4.8 mg
crushed ALO-02 40 mg/4.8 mg in solution + placebo ALO-02 (intact)
Active Comparator: Treatment F Drug: crushed oxycodone IR 40 mg
crushed oxycodone immediate-release (IR) 40 mg in solution + placebo ALO-02 (intact)

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 before Screening Visit, and at least once in 8 weeks before the Screening Visit.

Exclusion Criteria:

  • Diagnosis of substance and/or alcohol dependence.
  • Subject has participated in, is currently participating in, or is seeking treatment for substance and/or alcohol related disorder.
  • History of sleep apnea.
  • Positive urine drug screen (UDS) for other that marijuana.
  • Positive for Hepatitis B or C and HIV on Screening.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01746901

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: NCT01746901     History of Changes
Other Study ID Numbers: B4531008
Study First Received: December 7, 2012
Last Updated: May 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Relative abuse potential study; oxycodone; nalteone; Opioid-related disorders; drug abusers
Chronic pain

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 22, 2013