NCT01746901

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at 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

December 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2013

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

October 19, 2018

Completed
Last Updated

October 19, 2018

Status Verified

December 1, 2017

Enrollment Period

6 months

First QC Date

December 7, 2012

Results QC Date

September 30, 2016

Last Update Submit

December 21, 2017

Conditions

Healthy

Keywords

Relative abuse potential study; oxycodone; nalteone; Opioid-related disorders; drug abusersChronic pain

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.

    0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose in treatment phase

  • 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.

    0.25, 0.5, 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.

    0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose in treatment phase

  • 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.

    pre-dose, 0.25, 0.5, 1, 1.5, 2 hours post-dose

Secondary Outcomes (33)

  • Take Drug Again: Peak Effect (Emax)

    12, 24, 36 hours post-dose

  • Take Drug Again: Mean Effect (Emean)

    12, 24, 36 hours post-dose

  • Take Drug Again: Minimum Effect (Emin)

    12, 24, 36 hours post-dose

  • Take Drug Again Effect at Hours 12, 24 and 36

    12, 24, 36 hours post-dose

  • Overall Drug Liking: Peak Effect (Emax)

    12, 24, 36 hours post-dose

  • +28 more secondary outcomes

Other Outcomes (15)

  • Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour

    0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

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

    0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

  • High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour

    pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

  • +12 more other outcomes

Study Arms (6)

Treatment A

PLACEBO COMPARATOR
Drug: Placebo

Treatment B

EXPERIMENTAL
Drug: intact ALO-02 60 mg/7.2 mg

Treatment C

EXPERIMENTAL
Drug: crushed ALO-02 60 mg/7.2 mg

Treatment D

ACTIVE COMPARATOR
Drug: crushed oxycodone IR 60 mg

Treatment E

EXPERIMENTAL
Drug: crushed ALO-02 40 mg/4.8 mg

Treatment F

ACTIVE COMPARATOR
Drug: crushed oxycodone IR 40 mg

Interventions

PlaceboDRUG

Placebo solution + Placebo ALO-02 (intact)

Treatment A
intact ALO-02 60 mg/7.2 mgDRUG

Placebo solution + ALO-02 60 mg/7.2 mg (intact)

Treatment B
crushed ALO-02 60 mg/7.2 mgDRUG

crushed ALO-02 60 mg/7.2 mg in solution + placebo ALO-02 (intact)

Treatment C
crushed oxycodone IR 60 mgDRUG

crushed oxycodone immediate-release (IR) 60 mg in solution + placebo ALO-02 (intact)

Treatment D
crushed ALO-02 40 mg/4.8 mgDRUG

crushed ALO-02 40 mg/4.8 mg in solution + placebo ALO-02 (intact)

Treatment E
crushed oxycodone IR 40 mgDRUG

crushed oxycodone immediate-release (IR) 40 mg in solution + placebo ALO-02 (intact)

Treatment F

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 before Screening Visit, and at least once in 8 weeks before the Screening Visit.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INC Research Toronto, Inc.

Toronto, Ontario, M5V 2T3, Canada

Location

Related Links

MeSH Terms

Conditions

Opioid-Related DisordersDrug MisuseChronic Pain

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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

December 7, 2012

First Posted

December 11, 2012

Study Start

February 1, 2013

Primary Completion

August 9, 2013

Study Completion

August 9, 2013

Last Updated

October 19, 2018

Results First Posted

October 19, 2018

Record last verified: 2017-12

Locations

CA(1)