Expired Study
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Overland Park, Kansas 66212


Purpose:

This study will evaluate the abuse potential of ALKS 5461.


Criteria:

Inclusion Criteria: - Have a body mass index (BMI) within the range of 18.0 to 30.0 kg/m2, inclusive, and a minimum weight of at least 50.0 kg - Be a current recreational opioid user who has used opioids for non-therapeutic purposes (ie for psychoactive effects) at least 10 times in their lifetime - Agree to use an approved method of contraception for the duration of the study unless surgically sterile or postmenopausal - Be willing and able to abide by all study requirements and restrictions - Additional criteria may apply Exclusion Criteria: - Have evidence of drug or alcohol dependence within the past 2 years - Have a positive drug screen for opioids, amphetamines, cocaine, or benzodiazepines upon admission to the clinic - Have a history of severe allergic reaction (including anaphylaxis) to any food, medication, or bee sting - Be currently pregnant, breastfeeding, or planning to become pregnant during the study - Currently have or have a history of allergy or hypersensitivity to opioid agonists, opioid antagonists or related drugs (eg, oxycodone, morphine, naltrexone, and naloxone) - Have a positive test result for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) - Have donated or lost more than 500 mL whole blood - Additional criteria may apply.


NCT ID:

NCT02413281


Primary Contact:

Study Director
Sanjeev Pathak, MD
Alkermes, Inc.


Backup Contact:

N/A


Location Contact:

Overland Park, Kansas 66212
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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