Daily Liraglutide for Nicotine Dependence

Inclusion Criteria

Eligible subjects will be males and females:

• 18 years of age or older who 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/m2 with one weight-related comorbidity (e.g. high blood pressure, high cholesterol, dyslipidemia) or greater than or equal to 30 kg/m2 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/HIPAA form.
• If current or past diagnosis of bipolar disorder, eligible if:
• No psychotic features
• 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

Subjects who present with and/or self-report the following criteria will not be eligible to participate in the study.

Smoking Behavior:

• 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.

Alcohol/Drug Use:

• 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.
• A positive urine drug screen for cocaine, methamphetamines, phencyclidine (PCP), barbiturates, and/or ecstasy (MDMA).
• Participants believed to have a false-positive result on the drug screen may continue with the study with investigator approval.

Medical:

• 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 in-person 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 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 HbA1c level of 6.5% or higher).
• Uncontrolled hypertension (BP systo