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Completed

NCT Number: NCT02218021

A Study of the Abuse Liability Potential of Samidorphan in Healthy, 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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Alkermes Investigational Site

Overland Park, Kansas, 66212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Samidorphan

Drug

Placebo

Drug

Oxycodone

Drug

Primary outcomes

  1. Pharmacodynamics: Abuse potential measured by visual analog scales (VAS)

    Time frame: Approximately 4 weeks

Secondary outcomes

  1. Safety: Incidence of adverse events (AEs)

    Time frame: Approximately 5.5 weeks

  2. Pharmacokinetics: Plasma concentrations of samidorphan and metabolite

    Time frame: Approximately 4 weeks

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 15, 2014
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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