A Study to Evaluate the Intranasal Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-103)

Inclusion criteria

• . Males or females, aged 18 to 55 years, inclusive, in good general health.
• . Body mass index (BMI) within the range of 18.0 to 33.0 kg/m2, inclusive, and a minimum weight of 50.0 kg.
• . Current opioid users who have used opioids for recreational (non-therapeutic) purposes (i.e., for psychoactive effects) at least 10 times in the past year and at least once in the 12 weeks before Screening.
• . Must have experience with intranasal opioids for the purpose of recreational (non-therapeutic) use on at least 3 occasions in the year prior to Screening.
• . Must not be physically dependent on opioids, as demonstrated by successful completion of the Naloxone Challenge Test.
• . Must meet Drug Discrimination Test eligibility criteria (Section 8.3).
• . Female subjects must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at randomization. Post-menopausal women (i.e., no menstrual period for at least one year) must have a follicle-stimulation hormone (FSH) level \>30 milli-international unit (mIU)/mL at Screening.
• . Female subjects must use a medically acceptable method of birth control (oral or transdermal contraceptives, condom, spermicidal foam, intrauterine device (IUD), progestin implant or injection, heterosexual abstinence, vaginal ring or sterilization of partner) from the time of Screening through 2 weeks after the last study treatment.

Exclusion criteria