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A Study to Evaluate Withdrawal Effects Following Dosing of Oxycodone/Naltrexone in Methadone-Maintained Subjects

NCT02391571 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2016-08-10

No results posted yet for this study

Summary

This single-center study is a randomized, double-blind, active-controlled, multiple-dose, parallel group study to evaluate the potential withdrawal effects, safety and tolerability, and pharmacokinetic and pharmacodynamic effects of multiple doses of oral intact Oxycodone/Naltrexone capsules compared to oxycodone in methadone-maintained opioid-dependent subjects. The study will consist of a Screening Phase, an inpatient Treatment Phase (including a methadone stabilization period, a placebo administration period, a treatment administration period and a safety/washout period), and a Follow-up Phase.

Conditions

  • Withdrawal Symptoms

Interventions

DRUG

Oxycodone/Naltrexone Capsules

Oxycodone/Naltrexone to be taken with stable dose of Methadone

DRUG

Oxycodone

Oxycodone to be taken with stable dose of Methadone

DRUG

Placebo

2 day placebo run in prior to test and active drug phase of study

Sponsors & Collaborators

  • Elite Laboratories, Inc

    lead INDUSTRY

Principal Investigators

  • Debra Kelsh, MD · Vince and Associates

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02391571 on ClinicalTrials.gov