Exenatide Once Weekly for Smoking Cessation

Exenatide Once Weekly for Smoking Cessation: A Randomized Clinical Trial

The purpose of this study is to identify a potential new treatment for smoking cessation.

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.