Does CERC-501 Attenuate Stress-precipitated Smoking Lapse?
Condition: Smoking
Intervention: CERC-501; Placebo
Intervention description: CERC-501; Placebo
Intervention MeSH terms: Aticaprant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 17.0
Sex: All
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human
      Laboratory Model of Stress-precipitated Smoking Behavior.
    

Eligibility criteria:

        Inclusion Criteria

          1. Provides written informed consent and agrees to complete required clinic visits

          2. Male or female 21 to 60 years of age inclusive

          3. Body mass index (BMI) 18.5 to 40 kg/m2 inclusive

          4. Smokes at least 10 cigarettes per day on average for the past 6 months

          5. Fagerstrom score ≥3 at screening

          6. Currently not seeking smoking cessation therapy

          7. Urine dip test for cotinine concentration >150 ng/mL

          8. In otherwise good general health without any unstable medical conditions (as
             determined by medical history, medication history, physical examination, 10- or 12
             lead ECG, vital signs, and clinical laboratory testing)

          9. Able to read, write, and speak English

         10. Females must be either:

               1. Post-menopausal (amenorrhea for at least 12 consecutive months), surgically
                  sterile -or-

               2. Women of childbearing potential (WOCBP) must meet the criteria below:

             i. Uses an acceptable double-barrier method of contraception as determined by the
             Investigator -and- ii. 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.

         11. Male subjects must agree to use a condom if partner is of childbearing potential

        Exclusion Criteria

          1. Have used tobacco or other nicotine containing products other than cigarettes (e.g.,
             nicotine patches, pipe, cigars, snuff, chewing tobacco or e-cigarettes) within the
             past 30 days

          2. Any substance use disorder other than nicotine or caffeine as assessed by the
             Structured Clinical Interview-IV Axis I Disorders (SCID) for Diagnostic and
             Statistical Manual of Mental Disorders (DSM)

          3. Current neurological conditions that interfere with study conduct, assessment or
             treatment in any significant fashion

          4. Any lifetime history of bipolar I, II; schizophrenia or any other psychotic disorders;
             personality disorders, impulse control disorders as assessed by the SCID-IV

          5. 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. We will screen for worsening of
             symptoms of depression and/or suicidality at each medication appointment and lab
             sessions by having participants complete the Beck Depression Inventory (BDI) and the
             Columbia-Suicide Severity Rating Scale (C-SSRS). If there is a worsening of symptoms
             of depression and/or suicidality, the participants will speak a licensed psychologist
             for evaluation.

          6. Recent active or past history of gastric disease such as peptic ulcer disease,
             gastritis, upper gastrointestinal bleeding, or any gastrointestinal malignancy or
             precancerous condition

          7. Active, comorbid disease that might limit the ability of the subject to participate in
             the study as determined by the Study MD (i.e., poorly controlled diabetes mellitus,
             congestive heart failure, etc.)

          8. Clinically significant clinical laboratory test taken during screening

          9. Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2 times
             the upper limit of normal (ULN)

         10. Human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C positive as determined
             by serology testing at Screening

         11. Positive ethanol breath test at screening or prior to dosing on Days 1 and 8 of each
             treatment period

         12. Positive urine drug test at screening or and/or prior to dosing on Days 1 and 8 of
             each treatment period except for cannabis

         13. History of severe allergies or multiple adverse drug reactions

         14. Known hypersensitivity to CERC-501

         15. Current use of a proton pump inhibitor or histamine 2 blocker

         16. 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

         17. Current use of any psychoactive medications including: antipsychotics,
             benzodiazepines, mood stabilizers, selective serotonin reuptake inhibitor/serotonin
             norepinephrine reuptake inhibitor (SSRI/SNRI) or other antidepressants mood
             stabilizers