Clinical trial NCT03178422 (phase 2, status: completed)
Conditions: smoking cessation
ICD codes: Y36.881S, Y36.891S, Y36.880S, Y36.881A, Y36.881D, Y36.890S, Y36.891A
Drugs: cqss2, nicoderm cq patch
SMILES: CN1CCC[C@H]1C1=CN=CC=C1, CN1CCC[C@H]1C1=CN=CC=C1
Eligibility criteria:

        Inclusion Criteria:

        To be eligible for study participation, subjects must meet the following inclusion
        criteria:

          1. Ability to participate fully in all aspects of the study.

          2. Ability to understand and sign the study informed consent form.

          3. English-speaking, literate males and females.

          4. Age ≥18 years.

          5. Smokers consuming on average >10 cigarettes per day for the past 6 months, confirmed
             by self report.

          6. Carbon monoxide (CO) level ≥10 ppm, as determined by a Smokerlyzer breath test.

          7. Subject is in good health as determined by the Investigator.

          8. Subject has no known issues with completing all study visits.

          9. Subject must have regular access to Verizon Wireless at home as verified by
             www.opensignal.com or www.sensorly.com, at home wifi, or known connectivity to Verizon
             Wireless.

        Exclusion Criteria:

        Subjects will be excluded from this study if they do not fulfill the inclusion criteria, or
        if any of the following conditions are observed:

          1. Subjects with screening clinical laboratory tests (complete blood count [CBC] with
             differential and platelets, and chemistry profile) outside the normal range and
             considered to be clinically significant by the Investigator.

          2. Subjects with severe hepatic, renal, cardiovascular, endocrine, or hematologic
             diseases who demonstrate abnormal electrolyte, hematology, and/or liver function
             (albumin, total protein, bilirubin) results on the screening blood laboratory tests,
             or with a history or illness that may (in the opinion of the Investigator) confound
             the results of the study or pose additional risk. Because these disorders may occur
             either alone or in combination, this judgment is left to the discretion of the
             Investigator caring for the subject.

          3. Subjects who are immunocompromised; have an infection or suspected infection with
             tuberculosis (TB) or hepatitis C virus (HCV); or have a suspected infection with, or
             history of, human immunodeficiency virus (HIV) or hepatitis B virus (HBV).

          4. Subjects with positive screening urine test for drugs of abuse, including opiates,
             amphetamines, barbiturates, methadone, oxycodone, benzodiazepines, cocaine,
             phencyclidine, methamphetamine, ecstasy, or cannabinoids; or with a history of use of
             cocaine, heroin, recreational drugs (e.g., MDMA/"ecstasy"), methamphetamine, or
             hallucinogens at any time during the past 3 months; or use of marijuana on a weekly
             basis for the past 3 months.

          5. Subjects with recent history (past 3 months) of abuse of, or dependence on, a
             substance other than tobacco, including: heavy alcohol consumption (i.e., if male,
             drinking >4 alcoholic beverages per day for the past month and, if female, drinking >3
             alcoholic beverages per day for the past month).

          6. Subjects with physical examination (PE) abnormal findings considered to be clinically
             significant by the Investigator.

          7. Subjects with tattoos that could interfere with skin assessments.

          8. Subjects with any sign of infection, dermatologic disease, or condition that would
             inhibit transdermal absorption or might interfere with the evaluation of a test site
             reaction in locations where the investigational product may be used; or infection or
             condition (e.g., respiratory infection, strep throat) that would prevent full
             participation in the study.

          9. Electrocardiogram (ECG) readings outside the normal range and considered to be
             clinically significant by the Investigator.

         10. Subjects with:

               -  moderately severe or severe depression, as defined by a Patient Health
                  Questionnaire (PHQ-9) total score of ≥10, or

               -  suicidal ideation, as defined by a PHQ-9 score ≥1 in response to question 9,
                  "Thoughts that you would be better off dead, or of hurting yourself."

         11. Subjects with a history of psychosis, bipolar disorder, suicide attempt,
             schizophrenia, or any other significant psychiatric history that the Investigator
             believes may interfere with the subject's participation in the study.

         12. Subjects who have used an antipsychotic medication within the past 30 days. Subjects
             may be enrolled into the study if currently on a stable dose of antidepressant for the
             past 30 days and the dose is not expected to change throughout the duration of the
             study.

         13. Subjects who require any medications that may interfere with the absorption,
             metabolism, or excretion of the study drug.

         14. Subjects who have had a known reaction to nicotine replacement therapy (NRT) products
             or components.

         15. Subjects who score <6 on the Visual Analogue Scale (VAS) for Motivation to Quit
             Smoking.

         16. Women who are, or intend to become, pregnant during the course of this study, are
             currently breastfeeding, or women who refuse to use at least one method of birth
             control for the duration of the study.

         17. Subjects who have used any treatments for tobacco dependence within the past 30 days.

         18. Subjects who have used an investigational drug within the past 30 days or are involved
             in an ongoing clinical study.

         19. Subjects who plan on using forms of nicotine other than cigarettes (e.g.,
             e-cigarettes, smokeless tobacco) throughout the duration of the clinical study.

         20. Subjects with a history of illness that may (in the opinion of the Investigator)
             confound the results of the study or pose additional risk.

         21. Subjects with another household member or known relative participating in the study.

         22. Subjects who have participated and been treated in any previous Chrono Therapeutics
             clinical study.

         23. Subjects who work third shift or who otherwise stay awake all night and sleep during
             daylight hours.

         24. Subjects who do not have access to the internet (access can be through a personal
             computer, smartphone, library computer, etc.).