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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02218021
Recruitment Status : Completed
First Posted : August 15, 2014
Last Update Posted : December 2, 2014
Information provided by (Responsible Party):
Alkermes, Inc.

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Samidorphan Drug: Placebo Drug: Oxycodone Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : August 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Oxycodone

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Pharmacodynamics: Abuse potential measured by visual analog scales (VAS) [ Time Frame: Approximately 4 weeks ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02218021

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United States, Kansas
Alkermes Investigational Site
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Alkermes, Inc.
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Study Director: Sanjeev Pathak, MD Alkermes, Inc.
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Responsible Party: Alkermes, Inc. Identifier: NCT02218021    
Other Study ID Numbers: ALK33-012
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014
Keywords provided by Alkermes, Inc.:
ALKS 5461
Additional relevant MeSH terms:
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Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents