Restoring Cognitive Control (ReCon) in Acute Nicotine Withdrawal
Condition: Impulse Control Disorders
MeSH terms: Disruptive, Impulse Control, and Conduct Disorders
Intervention: SXC-2023; Placebos
Intervention description: SXC-2023 oral capsules; Matching Placebo oral capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 25 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: SXC-2023; Cognitive Control; Impulsivity; Delay Aversion; Top Down Processing; Behavioral Addiction

Summary:

      The purpose of this study is to explore the safety, tolerability and activity of SXC-2023 or
      placebo when dosed for 5 days in adults with tobacco use disorder who voluntarily abstain
      from the use of cigarettes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult, female or male, 28-55 years of age, inclusive at screening.

          2. BMI ≥ 16.0 and ≤ 35.0 kg/m2 at screening.

          3. Has provided signed written informed consent and has willingness and ability to comply
             with all aspects of the protocol, including abstaining from the use of
             tobacco/nicotine products for two 5-day periods.

          4. Non-treatment seeking smokers regularly using tobacco with a FTND score ≥4 at
             screening and self-reported use of ≥10 cigarettes/day at screening.

          5. Has smoked for >5 years at screening.

          6. Meets Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5)
             criteria for tobacco use disorder.

          7. Must have a score ≥ 4 on the FTND and an expired-air CO level ≥10 ppm during initial
             screening and prior to first dose.

          8. For a female of childbearing potential: either be sexually inactive (abstinent as a
             life style) for 28 days prior to the first dosing and throughout the study or be using
             one of the following acceptable birth control methods:

               -  Oral contraceptives used for at least 3 months prior to the first dose.

               -  Non-hormone releasing intrauterine device for at least 3 months prior to the
                  first dose and with either a physical (e.g., condom, diaphragm, or other) or a
                  chemical (e.g., spermicide) barrier method from the time of screening and
                  throughout the study.

               -  Double physical barrier method (e.g., condom and diaphragm) from 14 days prior to
                  the first dose and throughout the study.

          9. Female of non-childbearing potential: must have undergone one of the following
             sterilization procedures, at least 6 months prior to the first dose:

               1. hysteroscopic sterilization;

               2. bilateral tubal ligation or bilateral salpingectomy;

               3. hysterectomy;

               4. bilateral oophorectomy; Or be postmenopausal with amenorrhea for at least 1 year
                  prior to the first dose with serum follicle stimulating hormone levels consistent
                  with postmenopausal status or have medically documented history of biological or
                  congenital sterility.

         10. Has not used Aricept 30 days prior to screening.

        Exclusion Criteria:

          1. Subject is mentally or legally incapacitated or has significant emotional problems or
             clinically significant abnormality at the time of the screening visit or expected
             during the conduct of the study.

          2. Subject suffered a concussion 6 months or less prior to screening.

          3. Females who are pregnant or breastfeeding.

          4. Positive for active hepatitis, human immunodeficiency virus (HIV), coagulopathy, or
             hepatic illness.

          5. Use of Selective Serotonin or Norepinephrine Reuptake Inhibitors for psychiatric
             illness (e.g. depression, anxiety, etc.), unless subject has been on a stable dose for
             at least 30 days prior to screening.

          6. Use of antipsychotics or use of antiepileptics within 30 days prior to screening.

          7. Use of NAC within 30 days prior to screening.

          8. Use of Chantix or related smoking cessation medications (e.g., NicoDerm patch,
             Nicorette gum, etc) within 30 days prior to the first dose.

          9. Use of sulfasalazine (Azulfidine®) within 30 days prior to the first dose.

         10. DSM-5 criteria for alcohol/substance use disorder (except for tobacco use disorder).

         11. History or presence of clinically significant psychiatric condition (except for
             tobacco use disorder) or disease in the opinion of the PI or designee.

         12. History of any illness that, in the opinion of the PI or designee, might confound the
             results of the study or poses an additional risk to the subject by their participation
             in the study.

         13. History of seizures.

         14. Any history of psychiatric hospitalization in the past year.

         15. Currently participating in a clinical study.

         16. Previously participated in any Phase 1 Promentis studies or dosed in this Phase 2A
             study.

         17. FTND score <4 and expelled CO levels <10 ppm at screening and prior to first dose.

         18. Any clinically significant laboratory, ECG and/or vital sign abnormalities at
             screening.

         19. Unable to read/understand/speak English.