NCT01775189

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Feb 2013

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
4 years until next milestone

Results Posted

Study results publicly available

July 17, 2017

Completed
Last Updated

July 17, 2017

Status Verified

February 1, 2017

Enrollment Period

5 months

First QC Date

January 22, 2013

Results QC Date

October 6, 2016

Last Update Submit

April 17, 2017

Conditions

Healthy

Keywords

Relative abuse potential studyChronic painoxycodonenaltrexoneopioid-related disordersdrug abusers

Outcome Measures

Primary Outcomes (4)

  • Drug Liking: Peak Effect (Emax)

    Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the extreme left with "strong disliking" (score of 0 mm) and on the extreme right with "strong liking" (score of 100 mm). Peak Effect (Emax) = Maximum observed score.

    Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

  • Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour

    Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the extreme left with "strong disliking" (score of 0 mm) and on the extreme right with "strong liking" (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours.

    Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2 hours post-dose

  • High: Peak Effect (Emax)

    High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.

    Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

  • High: Area Under Effect Curve (AUE) From 0-2 Hour

    High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours.

    Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 hours post-dose

Secondary Outcomes (31)

  • Take Drug Again: Peak Effect (Emax)

    Intervention period: 12, 24 hours post-dose

  • Take Drug Again: Mean Effect (Emean)

    Intervention period: 12, 24 hours post-dose

  • Take Drug Again Effect at Hours 12 and 24

    Intervention period: 12, 24 hours post-dose

  • Overall Drug Liking: Peak Effect (Emax)

    Intervention period: 12, 24 hours post-dose

  • Overall Drug Liking: Mean Effect (Emean)

    Intervention period: 12, 24 hours post-dose

  • +26 more secondary outcomes

Other Outcomes (23)

  • Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hour

    Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

  • Drug Liking: Time to Maximum (Peak) Effect (TEmax)

    Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

  • High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hours

    Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

  • +20 more other outcomes

Study Arms (4)

Treatment A

PLACEBO COMPARATOR
Drug: ALO-02 weight-matched placebo

Treatment B

EXPERIMENTAL
Drug: crushed ALO-02 30 mg/3.6 mg

Treatment C

PLACEBO COMPARATOR
Drug: oxycodone weight-matched placebo

Treatment D

ACTIVE COMPARATOR
Drug: crushed oxycodone IR 30 mg

Interventions

ALO-02 weight-matched placeboDRUG

crushed sugar spheres (powder) x 1 dose

Treatment A
crushed ALO-02 30 mg/3.6 mgDRUG

crushed ALO-02 30 mg/3.6 mg capsule x 1 dose

Treatment B
oxycodone weight-matched placeboDRUG

crushed lactose tablets (powder) x 1 dose

Treatment C
crushed oxycodone IR 30 mgDRUG

Three (3) crushed immediate-release (IR) oxycodone 10 mg tablets x 1 dose

Treatment D

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INC Research Toronto Inc.

Toronto, Ontario, M5V 2T3, Canada

Location

Related Publications (1)

  • 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.

    PMID: 26011742DERIVED

Related Links

MeSH Terms

Conditions

Chronic PainOpioid-Related DisordersDrug Misuse

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2013

First Posted

January 24, 2013

Study Start

February 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 17, 2017

Results First Posted

July 17, 2017

Record last verified: 2017-02

Locations

CA(1)