Liraglutide and Smoking Cessation Behavioral Counseling in Helping Smokers to Quit Smoking

Inclusion Criteria

• Self‐report smoking cigarettes (menthol and non‐menthol) at least 10 times per day, on average, for the past 6 months
• Interested in quitting smoking (defined as “intend to quit within one month”)
• Body mass index (BMI) greater than or equal to 27 kg/m^2 with one weight‐related comorbidity (e.g. high blood pressure, high cholesterol, dyslipidemia) or greater than or equal to 30 kg/m^2 per the manufacturer label for weight management
• Women of childbearing potential (based on medical history) must consent to use a medically accepted method of birth control (e.g., condoms and spermicide, oral contraceptive, Depo‐Provera injection, contraceptive patch, intrauterine device [IUD], tubal ligation) or agree to abstain from sexual intercourse during the time they are in the study
• Able to communicate (speak, read, and write) fluently in English
• Capable of giving written informed consent before any study‐related activities, which includes compliance with the requirements and restrictions listed in the combined consent/Health Insurance Portability and Accountability Act (HIPAA) form
• If current or past diagnosis of bipolar disorder, eligible if: * No psychotic features * Montgomery-Asberg Depression Rating Scale Questionnaire (MADRS): total score less than 8 (past 4 weeks); suicidal item score less than 1 (past 4 weeks) * Young Mania Rating Scale (Y‐MRS): total score less than 8 (past 4 weeks); irritability, speech content, disruptive or aggressive behavior items score less than 3 (past 4 weeks) * No psychiatric hospitalization or emergency room visits for psychiatric issues in the past 6 months * No aggressive or violent acts or behavior in the past 6 months

Exclusion Criteria

• Current enrollment in a smoking cessation program, or use of other smoking cessation medications (e.g. Chantix/varenicline, Zyban/bupropion, nicotine replacement therapy/gum/patch, etc.) in the last month or plans to do either in the next 2 months
• Daily use of chewing tobacco, snuff and/or snus, or electronic cigarettes
• Self‐report current alcohol consumption that exceeds 25 standard drinks/week over the past 6 months
• Current untreated and unstable diagnosis of severe substance use disorder (eligible if past use and/or if receiving treatment and stable for at least 30 days). Current untreated and unstable moderate substance use disorder requires study physician approval
• Providing a breath alcohol concentration (BrAC) reading greater than 0.00
• A positive urine drug screen for cocaine, methamphetamines, phencyclidine (PCP), barbiturates, and/or ecstasy (3,4-methylenedioxymethamphetamine [MDMA]) * Those who screen positive for amphetamines, benzodiazepines, methadone, oxycodone, and/or and opiates (low level cut‐off 300 ng/mL) and who are prescribed these medications will be reviewed on a case‐by‐case basis by the principal investigator (PI) and study physician. Participants believed to have a false‐positive result on the drug screen may continue with the study with investigator approval
• Females who self‐report current pregnancy, planning a pregnancy during the study, currently breastfeeding/lactating, or not using adequate contraceptive measures. All female participants will undergo a urine pregnancy test at intake and at every study visit
• Current diagnosis of unstable and untreated major depression, as determined by self‐report & Mini International Neuropsychiatric Interview (MINI) (eligible if stable for at least 30 days)
• Current or past diagnosis of psychotic disorder, as determined by self‐report or MINI. Mood disorder with psychotic features determined by MINI requires PI approval for eligibility
• Suicide risk on the Columbia‐Suicide Severity Rating Scale (C‐SSRS) indicated by active suicidal ideation (within the past 30 days), any suicidal attempt within the past 2 years, or 2 or more lifetime suicidal attempts
• Self‐reported kidney and/or liver disease or transplant
• Heart/cardiovascular disease (e.g., angina, coronary heart disease, stroke, etc.) in the past 6 months
• Type‐1 or type‐2 diabetes (previously diagnosed or indicated by glycosylated hemoglobin measurement [HbA1c] level of 6.5% or higher)
• Uncontrolled hypertension (blood pressure [BP] systolic greater than 159 and/or diastolic greater than 99) * Participants presenting with systolic (S)BP greater than 159 mmHg and/or diastolic (D)BP greater than 99 mmHg at the intake visit will be instructed to sit quietly for 10 minutes. Then the participant will have a second blood pressure reading taken after a 10 minute period. If, after the second reading the SBP greater than 159 mmHg and the DBP greater than 99 mmHg, the individual will be instructed to sit comfortably for 10 minutes and then have a third blood pressure reading. If, after the third reading the SBP greater than 159 mmHg and the DBP greater than 99 mmHg, the individual will be ineligible to participate
• Personal or family history of medullary thyroid carcinoma (MTC)
• Personal or family history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• History of pancreatitis
• History of gallbladder disease
• A blood glucose level less than 70 mg/dl at the intake visit
• Prior history, or plans, of surgical intervention for weight loss
• Known or suspected allergy to liraglutide, excipients, or related products
• Current or recent use (last 14 days) of weight loss medication, and/or use of medications known to impact weight (e.g. corticosteroids)
• Current, anticipated, or pending enrollment in another research program over the next 2‐3 months that could potentially affect subject safety and/or the study data/design as determined by the principal investigator and/or study physician
• Not planning to live in the area for the next 9 months
• Previous participation in this trial (i.e., previously randomized and started study medication)
• Any impairment (physical and/or neurological) including visual or other impairment preventing ability to complete study tasks
• Inability to provide informed consent or complete any of the study tasks as determined by the principal investigator