Exenatide for Smoking Cessation and Prevention of Weight Gain

Exclusion Criteria

• •Psychoactive substance abuse or dependence (excluding nicotine dependence) within the past 3 months (existing diagnosis or as determined by the structured interview)
• •Currently using chewing tobacco, snuff, snus or electronic cigarettes
• •Currently enrolled in a smoking cessation program/research study or using pharmacotherapy for smoking cessation (NRT, varenicline, or bupropion)
• •Currently enrolled in a behavioral weight management plan/research study, or taking medication used for weight management (i.e., orlistat, lorcaserin,\*naltrexone-bupropion, liraglutide, phentermine, benzhetamine, diethylpropion, phendimetrazine), or medication known to impact weight (i.e., corticosteroids) \*Note: Withdrawn from the market in Feb 2020, but some patients may still be taking it
• •Currently using oral or injectable glucose lowering medications
• •Urine drug test positive, before randomization, for any of the following substances: benzodiazepines, cocaine, opioids,\*amphetamines, methamphetamine, buprenorphine, barbiturates, 3,4-methylenedioxy-methamphetamine (MDMA), and/or THC. \*Note: If positive for opioids or oxycodone but recent opioid use for acute pain is reported by the study candidate, then the candidate can be included at the discretion of the Primary Investigator and/or Study Physician
• •Psychotic or bipolar disorder, or mood disorder with psychotic features, or eating disorder (existing diagnosis or as determined by the structured interview)
• •Moderate to high risk for suicidality (as determined by the structured interview)
• •Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
• •Type 1 or type 2 diabetes mellitus (previously diagnosed or indicated by HbA1C level of ≥6.5%)
• •Severe cardiovascular disease (history of myocardial infarction, life-threatening arrhythmia, or worsening angina pectoris)
• •Severe gastrointestinal disease (i.e., severe gastroparesis)
• •Previous history of pancreatitis or risk of pancreatitis
• •Creatinine clearance \<45 mL/min or end stage renal disease (ESRD)
• •Previous medically adverse reaction to the study medications or nicotine
• •Women who are currently pregnant, or plan to become pregnant, or lactating, or of childbearing potential and are not using medically accepted forms of contraception. Medically accepted forms of contraception are specified in the inclusion criterion 8.
• •Current, anticipated, or pending enrollment in another research study over the next 6 months that could potentially affect subject safety and/or the study data/design as determined by the PI and/or Study Physician
• •Unable to communicate (read, write, and speak) fluently in English
• •Have any illness or condition which in the opinion of the PI and/or the Study Physician would preclude safe and/or successful completion of the study.