A Study of the Abuse Liability Potential of ALKS 5461 in Healthy, Non-Dependent, Recreational Opioid Users

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

This study will evaluate the abuse potential of ALKS 5461.

Key facts

Study ID: NCT02413281
Run by: Alkermes, Inc.
People needed: 56
Starts: 2015-03-01
Expected to finish: 2015-09-01
Last updated by the study team: 2015-11-10

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Alkermes Investigational Site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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