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

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NCT01746901

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Study Location
INC Research Toronto, Inc.
Toronto, Ontario, M5V 2T3, Canada
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Contact
1-800-718-1021
[email protected]
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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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers
Official Title  ICMJE 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 Nondependent,Recreational Opioid Users.
Brief Summary The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused.
Detailed Description Abuse Liability Study
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2017)		81
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2012)		30
Actual Study Completion Date  ICMJE August 9, 2013
Actual Primary Completion Date August 9, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01746901
Other Study ID Numbers  ICMJE B4531008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Syneos Health
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP