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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID

NCT02218021

Run by

Alkermes, Inc.

People needed

59

Starts

2014-08-01

Expected to finish

2014-11-01

Last updated by the study team

2014-12-02

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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