Exenatide Once Weekly 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 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: 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 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.