You are here

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

Last updated on March 22, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Toronto, Ontario, M5V 2T3 Canada
Contact
1-800-718-1021
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 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
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 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.

NCT01746901
Pfizer
Completed
A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers
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
The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused.
Abuse Liability Study
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Healthy
  • Drug: Placebo
    Placebo solution + Placebo ALO-02 (intact)
  • Drug: intact ALO-02 60 mg/7.2 mg
    Placebo solution + ALO-02 60 mg/7.2 mg (intact)
  • Drug: crushed ALO-02 60 mg/7.2 mg
    crushed ALO-02 60 mg/7.2 mg in solution + placebo ALO-02 (intact)
  • Drug: crushed oxycodone IR 60 mg
    crushed oxycodone immediate-release (IR) 60 mg in solution + placebo ALO-02 (intact)
  • Drug: crushed ALO-02 40 mg/4.8 mg
    crushed ALO-02 40 mg/4.8 mg in solution + placebo ALO-02 (intact)
  • Drug: crushed oxycodone IR 40 mg
    crushed oxycodone immediate-release (IR) 40 mg in solution + placebo ALO-02 (intact)
  • Placebo Comparator: Treatment A
    Intervention: Drug: Placebo
  • Experimental: Treatment B
    Intervention: Drug: intact ALO-02 60 mg/7.2 mg
  • Experimental: Treatment C
    Intervention: Drug: crushed ALO-02 60 mg/7.2 mg
  • Active Comparator: Treatment D
    Intervention: Drug: crushed oxycodone IR 60 mg
  • Experimental: Treatment E
    Intervention: Drug: crushed ALO-02 40 mg/4.8 mg
  • Active Comparator: Treatment F
    Intervention: Drug: crushed oxycodone IR 40 mg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
August 2013
August 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01746901
B4531008
No
Not Provided
Not Provided
Pfizer
Pfizer
INC Research
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 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]



Call Now