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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

NCT01775189 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2017-07-17

Study results available
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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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01775189 on ClinicalTrials.gov