A Study of the Abuse Liability Potential of Samidorphan in Healthy, Non-Dependent, Recreational Opioid Users

December 1, 2014 updated by: Alkermes, Inc.

A Randomized, Double-Blind, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Abuse Potential and Safety of Orally Administered Samidorphan in Non-Dependent Recreational Opioid Users

The purpose of this study is to evaluate the abuse potential and safety of samidorphan in healthy, non-dependent, adult, recreational opioid users.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Alkermes Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be in good general physical health
  • Body mass index of 18-34 kg/m2, inclusive with minimum weight of 50 kg
  • Recreational opioid use experience for non-therapeutic purposes (at >/= 10 times in lifetime and >/= 1 in previous 3 months
  • Agree to use an approved method of birth control for the duration of the study
  • Additional criteria may apply

Exclusion Criteria:

  • Currently pregnant or breastfeeding
  • History of or current infection with hepatitis B virus, hepatitis C virus or HIV
  • Current or history of any clinically significant medical or psychiatric condition
  • Current or history of in the last 2 years of dependence on alcohol or any illicit drugs
  • Have used any prescription or over-the-counter medication, including natural health products (with the exception of prescription birth control or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days
  • Have a history of intolerance or hypersensitivity to opioid antagonists, opioid agonists or related drugs (eg, naltrexone, naloxone, oxycodone, morphine)
  • Additional criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Experimental: Samidorphan Dose 1
Experimental: Samidorphan Dose 2
Experimental: Samidorphan Dose 3
Active Comparator: Oxycodone Dose 1
Active Comparator: Oxycodone Dose 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacodynamics: Abuse potential measured by visual analog scales (VAS)
Time Frame: Approximately 4 weeks
Approximately 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety: Incidence of adverse events (AEs)
Time Frame: Approximately 5.5 weeks
Approximately 5.5 weeks
Pharmacokinetics: Plasma concentrations of samidorphan and metabolite
Time Frame: Approximately 4 weeks
Approximately 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Sanjeev Pathak, MD, Alkermes, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

August 14, 2014

First Submitted That Met QC Criteria

August 14, 2014

First Posted (Estimate)

August 15, 2014

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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