Nicotine Replacement Therapy, Counseling, Varenicline, and Bupropion for Smoking Cessation, the PISCES I Trial

Inclusion Criteria

• Age: >=18 years old
• Smoking 5 or more cigarettes, little cigars and/or cigarillos per day, on average, within the past 30 days preceding the screening visit and expired carbon monoxide (CO) >= 6 ppm and/or a urine NicCheck test > 0 (or a reading of positive if an alternate nicotine test used)
• Interested in treatment that might change smoking behavior or help them quit smoking
• Able to follow verbal and written instructions in English and complete all aspects of the study
• Provide informed consent and agree to all assessments and study procedures
• Have an address and telephone number where they may be reached
• Willing and able to use a smartphone or device of their own to complete required assessments. If participant does not have a reliable device, they will be excluded only if we have no devices on hand to loan
• Subjects must report current stable residence in the state of Texas and must not have plans to move out of state in the next 6 months. Stable residence is a domicile in which an individual can operate as if it were his or her own homestead and does not include shelters, halfway houses, treatment centers, or group homes
• Be the only participant in their household currently receiving treatment on this protocol
• Agree to be treated via telehealth (live audio-video conference and phone) and to be contacted via text and/or email
• Willing to refrain from the use of other nicotine/tobacco products for the duration of the study

Exclusion Criteria

• Current enrollment or plans to enroll in another smoking cessation program during the study time frame, including plans to use other smoking cessation medications (i.e., over the counter [OTC] or prescription medication for smoking cessation) or smoking cessation treatments
• Serious or unstable medical or psychiatric disorder within the past 3 months, as determined by the study physician
• Being pregnant, engaging in breast-feeding, or being of childbearing potential and engaging in sexual activity that could lead to pregnancy and is not protected by a medically acceptable, effective method of birth control while enrolled in the study, as determined by self-report. Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD). Contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use
• Current use of certain medications: * Smoking cessation meds (last 7 days; e.g., bupropion, NRT, varenicline). Episodic use of NRT in the last 7 days may be considered if the participant agrees to only use study medication once randomized * Certain medications may be exclusionary and others are precautionary, to be evaluated on a case-by-case basis by study physician * Daily use of opioids for 30 days or more on phone screen or at screening is exclusionary, however as needed (PRN) use is allowed (i.e., 3 out of 7 days per week or less or if more frequent use in less than a month’s duration)
• History of hypersensitivity or allergic reaction to varenicline, NRT, or any component of these formulations as determined by the medical team
• Self-report of a history or current diagnosis of schizophrenia or bipolar disorder unless cleared by study physician
• Current substance use disorder (Drug Abuse Screening Test [DAST] score > 3 or use > 0 in the past year and refuses to refrain from use for the duration of the study; Alcohol Use Disorders Identification Test [USAUDIT] score > 24)
• Individuals who report depressive symptoms in the moderately severe or severe range on the Patient Health Questionnaire – Mood Module (PHQ-9) (scores of 15 or above); or who report current suicidal ideation on the PHQ-9
• Individuals who report anxiety symptoms in the severe range on the Generalized Anxiety Disorder Scale (GAD-7) (scores of 15 or above); or meet criteria for panic syndrome on the PHQ Panic module
• Psychiatric hospitalization within 1 year of screening date
• Any otherwise not specified medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the principal investigator and/or study physician
• Participant considered by the investigator as unsuitable candidate for full participation in both the treatment and follow-up phases of the study