- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02218021
A Study of the Abuse Liability Potential of Samidorphan in Healthy, Non-Dependent, Recreational Opioid Users
December 1, 2014 updated by: Alkermes, Inc.
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
The purpose of this study is to evaluate the abuse potential and safety of samidorphan in healthy, non-dependent, adult, recreational opioid users.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Overland Park, Kansas, United States, 66212
- Alkermes Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: Samidorphan Dose 1
|
|
Experimental: Samidorphan Dose 2
|
|
Experimental: Samidorphan Dose 3
|
|
Active Comparator: Oxycodone Dose 1
|
|
Active Comparator: Oxycodone Dose 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacodynamics: Abuse potential measured by visual analog scales (VAS)
Time Frame: Approximately 4 weeks
|
Approximately 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety: Incidence of adverse events (AEs)
Time Frame: Approximately 5.5 weeks
|
Approximately 5.5 weeks
|
Pharmacokinetics: Plasma concentrations of samidorphan and metabolite
Time Frame: Approximately 4 weeks
|
Approximately 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sanjeev Pathak, MD, Alkermes, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
August 14, 2014
First Submitted That Met QC Criteria
August 14, 2014
First Posted (Estimate)
August 15, 2014
Study Record Updates
Last Update Posted (Estimate)
December 2, 2014
Last Update Submitted That Met QC Criteria
December 1, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALK33-012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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