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

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NCT01775189

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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 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
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.

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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 Users When ALO-02 Capsules Are Crushed and Snorted
Official Title  ICMJE A Randomized, Double-blind, 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.
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 when they are crushed and snorted.
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: ALO-02 weight-matched placebo
    crushed sugar spheres (powder) x 1 dose
  • Drug: crushed ALO-02 30 mg/3.6 mg
    crushed ALO-02 30 mg/3.6 mg capsule x 1 dose
  • Drug: oxycodone weight-matched placebo
    crushed lactose tablets (powder) x 1 dose
  • Drug: crushed oxycodone IR 30 mg
    Three (3) crushed immediate-release (IR) oxycodone 10 mg tablets x 1 dose
Study Arms  ICMJE
  • Placebo Comparator: Treatment A
    Intervention: Drug: ALO-02 weight-matched placebo
  • Experimental: Treatment B
    Intervention: Drug: crushed ALO-02 30 mg/3.6 mg
  • Placebo Comparator: Treatment C
    Intervention: Drug: oxycodone weight-matched placebo
  • Active Comparator: Treatment D
    Intervention: Drug: crushed oxycodone IR 30 mg
Publications * Setnik B, Bramson C, Bass A, Levy-Cooperman N, Malhotra B, Matschke K, Sommerville KW, Wolfram G, Geoffroy P. Intranasal administration of crushed ALO-02 (extended-release oxycodone with sequestered naltrexone): A randomized, controlled abuse-potential study in nondependent recreational opioid users. J Clin Pharmacol. 2015 Dec;55(12):1351-61. doi: 10.1002/jcph.552. Epub 2015 Jul 2.

*   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: September 11, 2013)		45
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2013)		32
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 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 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.
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 NCT01775189
Other Study ID Numbers  ICMJE B4531009
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 February 2017

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