A Study in a Human Laboratory Model of Smoking Behavior

The study will be performed in subjects who are heavy cigarette smokers currently not seeking treatment for tobacco use disorder.

The study is a crossover design study (within-subject analysis), which allows for subjects to be their own control.

Each period of the crossover consists of a 7-day out-patient treatment period followed by a single in-patient testing day on Day 8. Subjects will participate in a laboratory session following the McKee Smoking Lapse Test and be discharged from the clinic to undergo a 7 day washout period followed by the second period of the crossover design and a 7-day follow-up visit.

Inclusion criteria

• Provides written informed consent and agrees to complete required clinic visits
• Male or female 21 to 60 years of age inclusive
• Body mass index (BMI) 18.5 to 40 kg/m2 inclusive
• Heavy Smokers
• Currently not seeking smoking cessation therapy
• In otherwise good general health without any unstable medical conditions (as determined by medical history, medication history, physical examination, 12-lead ECG, vital signs, and clinical laboratory testing)
• Able to read, write, and speak in English
• Females must be either:

• Post-menopausal (amenorrhea for at least 12 consecutive months), surgically sterile -or-
• Women of childbearing potential (WOCBP) must meet the criteria below:

• Uses an acceptable double-barrier method of contraception as determined by the Investigator -and-
• Is not lactating, has a negative serum beta human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test prior to dosing on Days 1 and 8 of each treatment period.
• Male subjects must agree to use a condom if partner is of childbearing potential

Exclusion criteria

Subjects meeting the following criteria are not eligible for the study:

• Any substance use disorder other than nicotine or caffeine as assessed by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) substance use disorder checklist in addition to the Mini-International Neuropsychiatric Interview (MINI) (to capture both DSM-V substance use disorder diagnoses)
• Current neurological conditions that interfere with study conduct, assessment or treatment in any significant fashion
• Any lifetime history of bipolar I, II; schizophrenia or any other psychotic disorders; personality disorders, impulse control disorders as assessed by the MINI
• Current psychiatric conditions that interfere with study conduct, assessment or treatment in any significant fashion, such as major depressive disorder (MDD), eating disorders, post-traumatic stress disorder, etc., without permission of the medical monitor
• Recent active or past history of gastric disease such as peptic ulcer disease, gastritis, upper gastrointestinal bleeding, or any gastrointestinal malignancy or precancerous condition
• Active, comorbid disease that might limit the ability of the subject to participate in the study as determined by the Investigator (i.e., poorly controlled diabetes mellitus, congestive heart failure, etc.)
• Clinically significant clinical laboratory test taken during screening, without permission of the Medical Monitor
• Elevated AST or ALT ≥ 2 times the upper limit of normal (ULN)
• Human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C positive as determined by serology testing at Screening
• History of severe allergies or multiple adverse drug reactions
• Known hypersensitivity to CERC-501
• Current use of a proton pump inhibitor or histamine 2 blocker without permission of the Medical Monitor
• Use of any investigational medication within 2 months prior to the start of this study or scheduled to receive an investigational drug other than the study drug during the course of this study