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CompletedNCT02218021Updated Dec 2, 2014

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

A Phase 1 interventional study of Samidorphan and Placebo in Healthy Volunteers, sponsored by Alkermes, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-02.

Sponsored by Alkermes, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Alkermes
  • ALKS 33
  • ALKS 5461
  • Samidorphan
03

In context

Lead sponsor

Alkermes, Inc. is the lead sponsor of 82 studies on the registry; 8 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    Samidorphan Dose 1

    Drug: Samidorphan

  • Experimental
    Samidorphan Dose 2

    Drug: Samidorphan

  • Experimental
    Samidorphan Dose 3

    Drug: Samidorphan

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Active comparator
    Oxycodone Dose 1

    Drug: Oxycodone

  • Active comparator
    Oxycodone Dose 2

    Drug: Oxycodone

Interventions

  • DrugSamidorphan
  • DrugPlacebo
  • DrugOxycodone
06

What researchers measure

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

07

Study locations

1 site
  • Alkermes Investigational Site
    Overland Park, Kansas 66212, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02218021
Lead sponsor
Alkermes, Inc.
Responsible party
Sponsor
First posted
Aug 15, 2014
Start date
Aug 2014
Primary completion
Nov 2014
Completion
Nov 2014
Last update
Dec 2, 2014

Study contacts

Sanjeev Pathak, MD
study director · Alkermes, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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