Behavioral Activation for Smoking Cessation and the Prevention of Post-Cessation Weight Gain

This is an interventional treatment trial for Smoking Cessation focused on measuring Smoking Cessation, Weight Loss Read More

Inclusion Criteria:

• Male and female treatment-seeking smokers who are between 18 and 65 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months.
• Plan to live in the area for the duration of the study (i.e. ~30 weeks/8 months).
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
• Smokers who wish to make a permanent quit attempt in the next 1-2 months (treatment-seeking), because our prior work suggests that motivated subjects are more sensitive to medication effects on smoking behavior.
• Able to communicate fluently in English (i.e. speaking, writing, and reading).
• Provide a Carbon Monoxide (CO) breath test reading greater than or equal to 5 parts per million (ppm) at the Intake Visit.

Exclusion Criteria:

Smoking Behavior.

• Regular use of nicotine containing products other than cigarettes (e.g. chewing tobacco, snuff, snus, cigars, e-cigs, etc.). Participants agreeing to abstain from using nicotine containing products other than cigarettes and the study-provided TN for the duration of trial will be considered eligible.
• Current enrollment or plans to enroll in another research and/or smoking cessation program over the duration of the study (i.e. ~30 weeks/8 months).
• Anticipated use (within the next ~30 weeks/8 months) of any nicotine substitutes and/or smoking cessation treatments/medications unless provided through the study.
• Provide a CO breath test reading less than 8 ppm at Intake Visit.

Alcohol and Drug.

• History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse. Counseling and support groups (e.g. Alcoholics Anonymous and Narcotics Anonymous) will not be considered medical treatment for the purposes of this protocol.
• Current alcohol consumption that exceeds 25 standard drinks/week.
• Breath alcohol reading (BrAC) greater than .000 at the Intake Visit.
• A positive urine drug screen (UDS) for cocaine, opiates, amphetamines, methamphetamines, phencyclidine (PCP), ecstasy (MDMA), barbiturates, benzodiazepines, methadone, and/or oxycodone at the Intake Visit.

Medical.

• Women who are pregnant, breast feeding, or planning a pregnancy over the duration of the study period. Women must agree to use an adequate form of contraception or abstain from sexual intercourse for the duration and for at least one month after the end of the study.
• Current treatment of cancer or diagnosed with cancer (except basal or squamous-cell carcinoma not treated with chemotherapy and/or radiation) in the past 6 months.
• Poorly controlled, brittle, or pump-dependent Type I diabetes.
• Current peptic ulcer bleeding.
• Allergy to adhesive tape.
• Skin problems or sensitivities. Eligibility will be evaluated on a case-by-case basis by the Study Physician.
• Active hepatitis or poorly controlled kidney and/or liver disease.
• Uncontrolled hypertension (systolic blood pressure [SBP] greater than 159 and/or diastolic blood pressure [DBP] greater than 99
• History of abnormal heart rhythms, tachycardia, and/or cardiovascular disease (e.g. stroke, angina, heart attack) may result in ineligibility. These conditions will be evaluated on a case-by-case basis by the Study Physician.
• History of epilepsy or seizures. Eligibility will be evaluated on a case-by-case basis by the Study Physician.
• Serious or unstable disease within the past 6 months. Notable diseases will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician.
• Any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing proper completion of the study procedures. Notable impairments will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician.
• Low or borderline intellectual functioning - determined by receiving a score of less than 75 on the Shipley Institute of Living Scale (SILS), which correlates with the Wechsler Adult Intelligence Scale-Revised (WAIS-R) Estimated Intelligence Quotient (IQ) Test.
• Applicable food allergies or disorders:

Galactosemia, Notable milk allergy (lactose intolerant participants may proceed unless they experience severe symptoms), Notable soy allergy, Peanut allergy

Psychiatric.

• Current diagnosis of major depression. Subjects with a history of major depression, in remission for 6 months or longer (may be stable on antidepressant medications), are eligible.
• Lifetime history of a suicide attempt.
• Lifetime history of schizophrenia, psychosis, and/or bipolar disorder.

Medication.

Current use or recent discontinuation (within the last 14 days) of:

• Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin Standard-Release, Chantix).
• Anti-psychotic medications.
• Prescription stimulants (e.g., Provigil, Ritalin, Adderall).
• Systemic steroids.

Current use of:

• Nicotine replacement therapy (NRT).
• Heart medications such as digoxin, quinidine, and nitroglycerin.

Daily use of:

• Opiate-containing medications for chronic pain.
• Inhaled corticosteroids.
• Benzodiazepines and/or Barbiturates.

General Exclusion.

• Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact subject safety, study data, and/or the study design as determined by the Principal Investigator and/or Study Physician.
• Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance as determined by the Principal Investigator and/or Study Physician. Subjects may be deemed ineligible for any of the aforementioned reasons at any point throughout the study, as well as during the initial telephone screen.
• Significant non-compliance with protocol and/or study design as determined by the Principal Investigator and/or Study Physician. Subjects may be deemed ineligible at any point throughout the study.
• Subjects failing to complete an in-person Baseline Visit will be excluded (no Principal Investigator determination required).