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A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers

NCT01746901 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2018-10-19

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.

Conditions

  • Healthy

Interventions

DRUG

Placebo

Placebo solution + Placebo ALO-02 (intact)

DRUG

intact ALO-02 60 mg/7.2 mg

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

DRUG

crushed ALO-02 60 mg/7.2 mg

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

DRUG

crushed oxycodone IR 60 mg

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

DRUG

crushed ALO-02 40 mg/4.8 mg

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

DRUG

crushed oxycodone IR 40 mg

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

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
2013-08-09
Completion
2013-08-09

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
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 NCT01746901 on ClinicalTrials.gov