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

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NCT01825447

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Salt Lake City, Utah, 84106 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01825447
Pfizer
Completed
A Study to Characterize the Abuse Liability of Intravenous Oxycodone Alone or in Combination With Intravenous Naltrexone in Healthy, Non-Dependent, Recreational Opioid Users

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[email protected]

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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 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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: Placebo
    0.9% sodium chloride for injection x 1 dose administered intravenously (IV) push over 4 min.
  • Drug: Oxycodone + Naltrexone
    Oxycodone hydrochloride (HCl) 20 mg IV and naltrexone HCl 2.4 mg IV administered simultaneously x 1 dose IV push over 4 min.
  • Drug: Oxycodone
    Oxycodone HCl 20 mg for injection x 1 dose IV push over 4 min.
  • Placebo Comparator: Treatment A
    Intervention: Drug: Placebo
  • Experimental: Treatment B
    Intervention: Drug: Oxycodone + Naltrexone
  • Active Comparator: Treatment C
    Intervention: Drug: Oxycodone
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
September 2013
September 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01825447
B4981002
No
Not Provided
Not Provided
Pfizer
Pfizer
Lifetree Clinical Research Center, Salt Lake City, Utah
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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