Tobacco Cessation: Treatment Delivery and Predictors of Outcome

• Participants will be individuals who present to the NIDA IRP seeking help to quit tobacco use (smoked or smokeless). We will enroll up to 1000 participants. All individuals who give signed consent and attend at least one study visit will be considered evaluable. We will not replace study dropouts.

INCLUSION CRITERIA:

1. 18 years of age or older
2. Seeking help for cessation of tobacco use

EXCLUSION CRITERIA:

1. Inability to give informed consent.
2. Current use (within the past 30 days) of any of the 7 FDA-approved first-line smoking-cessation treatments (varenicline, bupropion, or NRTs such as a nicotine inhaler, lozenge, patch, gum, or nasal spray), unless administered as part of another NIDA IRP protocol.
3. Any newly diagnosed or untreated acute medical illness that requires immediate medical attention. This includes any new medical diagnosis (for example, diabetes or hypertension) in someone who is not under the care of a physician and/or that is not well controlled. An untreated acute medical illness would include acute hepatitis, acute pancreatitis, acute respiratory distress syndrome, etc. Individuals may be considered for participation once a newly diagnosed condition is well controlled or an acute condition has resolved.

ADDITIONAL EXCLUSION FOR NRT:

1. Current major medical conditions that in the view of the investigators would compromise the integrity of the data or the safety of the participant, including moderate to severe cardiovascular disease (30 days post-MI, severe or worsening angina pectoris), life-threatening arrhythmias, acute phase cerebrovascular accident, COPD (emphysema and chronic bronchitis).
2. Current uncontrolled psychiatric condition that in the view of the investigators would compromise the integrity of the data or the safety of the participant, including bipolar disorders and any psychotic disorder. Uncontrolled psychiatric condition includes but is not limited to: psychiatric medication change in the last 3 months; or psychiatric exacerbation or related hospitalization in the last 3 months. Individuals with controlled Major Depressive Disorder under the care of a psychiatrist or internist may be considered for inclusion.
3. Pregnancy
4. Lab values outside of the values listed in Table 1 below.
5. Nicotine patch only: allergy to adhesive tape, generalized chronic dermatological disorders, weight <45kg, and/or lactation

ADDITIONAL EXCLUSION CRITERIA FOR VARENICLINE OR BUPROPION:

1. Pregnancy or nursing
2. Current diagnosis of schizophrenia or any other DSM-IV psychotic disorder, bipolar disorder, panic disorder, eating disorder (current or prior diagnoses), Major Depressive Disorder within the past year requiring treatment, or history of suicide attempt
3. History of seizures, except for febrile seizures in childhood
4. Current physical dependence on alcohol or sedative-hypnotics, e.g. benzodiazepines
5. Lab values outside of the values listed in Table 1 below
6. Unstable cardiovascular disease or cardiovascular events occurring within two months before screening
7. For bupropion only: current administration of monoamine oxidase inhibitors (MAO-I); at least 14 days must elapse between discontinuation of an MAO-I and initiation of treatment with bupropion; current administration (within past 30 days) Wellbutrin, Wellbutrin SR, Wellbutrin XL.