| Eligibility |
Inclusion Criteria:
1. Has signed the informed consent form (ICF) and is able to read and understand the
information provided in the ICF.
2. Smokers 21 to 65 years of age (inclusive) at screening.
3. Smokes an average of at least 10 commercially available cigarettes per day for the
last 12 months.
4. Has an expired air carbon monoxide (CO) reading of at least 10 ppm at screening.
5. At screening, express a desire to quit smoking within the next 30 days.
6. Body mass index (BMI) of 18 to 40 kg/m2, inclusive at screening.
7. Willing and able to comply with the requirements of the study.
8. Owns a smartphone with text message and data capabilities compatible with necessary
surveys.
Exclusion Criteria:
1. Participants of childbearing potential (CBP) who are breastfeeding and/or have a
positive pregnancy test result.
2. Participant presenting with, or having a history of, uncontrolled hypertension
(systolic blood pressure >150 mmHg or diastolic blood pressure > 95 mmHg) or
symptomatic hypotension.
3. Participants with known ischemic heart disease or history of myocardial infarction,
congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting,
coronary artery bypass surgery, or other serious cardiac problems that would place
him/her at increased vulnerability to the sympathomimetic effects of stimulant
medication.
4. History of seizures (after the age of 17 years).
5. Participants of CBP or sexually active participants unless they agree to practice 2
different methods of birth control or remain abstinent during the course of the trial
and for 30 days after the last dose of Investigation Medicinal Product (IMP) for
participants of CBP, and 30 days after the last dose of IMP for participants with
partners who are of CBP. Unless the participant is sterile (i.e., participants who
have had a bilateral oophorectomy or hysterectomy or who have been postmenopausal for
at least 12 consecutive months; or participants who have had a bilateral orchidectomy)
or remains abstinent, 2 of the following precautions must be used: vasectomy, tubal
ligation, vaginal diaphragm, intrauterine device, birth control pills, birth control
injection, birth control implant, birth control patch, condom with spermicide, or
sponge with spermicide. Participants who do not agree to refrain from donating sperm
from screening through 30 days after the last dose of IMP.
6. Participant has a history of dermatologic adverse reactions secondary to any drug
exposure or any active/uncontrolled dermatologic disease.
7. Currently taking antidepressants (e.g., selective serotonin reuptake inhibitors
(SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), Tricyclic
antidepressants (TCAs), or monoamine oxidase inhibitors (MAOIs)), antipsychotics (such
as butyrophenones, thioxanthenes, atypical antipsychotics or other heterocyclics),
benzodiazepines, hypnotics, or medications that prolong corrected QT Interval (QTc).
MAOI's taken within 30 days of screening.
8. Screening (Visit 1) or Baseline (Visit 2) Columbia-Suicide Severity Rating Scale
(C-SSRS) score greater than 0 (any answer "Yes") for the SUICIDAL IDEATION section or
greater than 0 for the SUICIDAL BEHAVIOR section (any answer "Yes").
9. Substance use disorder within 12 months prior to screening.
10. Participants that have a positive alcohol test (via breathalyzer or blood), a positive
drug screen for illicit drugs (Table 6.3.5) at screening or baseline.
Participants who test positive for marijuana at screening may be enrolled if they have
no evidence of a substance use disorder and if they agree to refrain from use for the
duration of the trial.
11. Any participant who has any other medical or physical condition(s) that, in the
opinion of the investigator, may prevent the participant from completing the trial or
would go against the participant's best interest with participation in the trial. This
would include any significant illness or unstable medical condition that could lead to
difficulty complying with the protocol.
12. Participants with abnormal laboratory tests, vital sign results, or ECG findings which
in the investigator's judgment are medically significant and that would impact the
safety of the participant or the interpretation of the trial results.
13. Participants with a history of prior exposure to centanafadine.
14. Use of smokeless tobacco (chewing tobacco, snuff), cigars (except for "Black & Mild"
cigars or Cigarillos), pipes, hookah, e-cigarettes, nicotine replacement therapy, or
other smoking cessation treatments (e.g., bupropion as Zyban, or varenicline) within
14 days of screening.
15. Participants who participated in a clinical trial and were exposed to interventional
trial medication within the last 30 days prior to screening or who participated in
more than 2 interventional clinical trials within the past year.
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