A Water Consumption Study of ALKS 5461 in Healthy Volunteers

Inclusion Criteria:

- Has a body mass index (BMI) of 18.0 - 30.0 kg/m^2

- Is in good physical health

- Agrees to use an approved method of contraception for the duration of the study

- Additional criteria may apply

Exclusion Criteria:

- Is currently pregnant or breastfeeding

- Has a history of substance abuse disorder

- Has used nicotine within 90 days prior to the study or anticipates a need to use
nicotine during the study period

- Has used any prescription or over-the-counter medication, including natural health
products or dietary supplements (with the exception of prescription contraceptives or
hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days
prior to study start

- Has used opioids within 30 days prior to screening, or has an anticipated need for
opioid medication at any point during the study

- Has used alcohol within 72 hours prior to any inpatient period

- Is a heavy caffeine drinker (regularly consuming 5 or more caffeinated beverages per
day)

- Has a history of intolerance or hypersensitivity to opioids (buprenorphine) or opioid
antagonists (naltrexone, naloxone)

- Additional criteria may apply