You are here

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

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
INC Research Toronto Inc.
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 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.

NCT01775189
Pfizer
Completed
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

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 Users When ALO-02 Capsules Are Crushed and Snorted
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.
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.
Abuse Liability Study
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Healthy
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
July 2013
July 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 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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01775189
B4531009
No
Not Provided
Not Provided
Pfizer
Pfizer
INC Research
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2017

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