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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02218021

Enrollment

Registered

2014-08-15

Start date

2014-08-31

Completion date

2014-11-30

Last updated

2014-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Alkermes, ALKS 33, ALKS 5461, Samidorphan

Brief summary

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

Interventions

DRUGSamidorphan

DRUGPlacebo

DRUGOxycodone

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

* 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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026