A Study of the Abuse Liability Potential of Samidorphan in Healthy, Non-Dependent, Recreational Opioid Users
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 2/7/2015 |
| Start Date: | August 2014 |
| End Date: | October 2014 |
| Contact: | Erin E. Daniel, MS |
| Email: | erin.daniel@covance.com |
| Phone: | 215-321-3786 |
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.
healthy, non-dependent, adult, recreational opioid users.
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
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