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

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the abuse potential of ALKS 5461.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Buprenorphine

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.