NCT02975297 trial results

Inclusion Criteria: * Be English-speaking volunteers who desire to quit smoking and are willing to make a quit attempt during the course of the study; * Have smoked ≥10 cigarettes a day for at least one year and provide a breath carbon monoxide (CO) ≥10 ppm; * Have a negative pregnancy test, if female of childbearing potential; * Have HbA1C levels between 5.7 and 6.4% or BMI of or greater than 25 kg/square meters * Not currently using any therapy for glycemic control (either injectable \[i.e. insulin\] or oral agents); * Have vital signs as follows: resting pulse between 50 and 95 bpm, BP between 90-150 mmHg systolic and 45-95 mmHg diastolic; * Have hematology and chemistry laboratory tests that are within reference limits (within 10% above or below), with the following exception: pancreatic tests (lipase and amylase) must be within normal limits; * Have a medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the principal investigator. Exclusion Criteria: * Meet criteria for the following psychiatric and/or substance use disorders as assessed by the Mini International Neuropsychiatric Interview (MINI): items C (current manic or hypomanic episode only), I (alcohol abuse - Alcohol Addendum-past 3 months only; current alcohol dependence), J (substance abuse -Substance Abuse Addendum - past 3 months only; current substance dependence), K (current psychotic disorder or current mood disorder with psychotic features). * Individuals who meet criteria for non-exclusionary psychiatric disorders that are considered clinically unstable and/or unsuitable to participate as determined by the Principal Investigator and/or Study Physician. * Individuals rated as moderate (9-16) to high (17 or greater) on suicidality as assessed by Module B of the MINI. * Have personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2; * Have type 1 diabetes mellitus; * Have severe cardiovascular disease (history of myocardial infarction, life-threatening arrhythmia, or worsening angina pectoris); * Have active temporomandibular joint disease; * Have severe gastrointestinal disease (i.e. severe gastroparesis); * Have previous history of pancreatitis or are at risk for pancreatitis; * Have creatinine clearance (CrCl) \< 30; * Have any previous medically adverse reaction to study medications, nicotine, or menthol; * Be pregnant or lactating or unwilling to provide a negative pregnancy test before study entry; * Not using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide); * Have any illness which in the opinion of the primary investigator would preclude safe and/or successful completion of the study.