Nicotine replacement therapy (NRT) is a well-tolerated and efficacious smoking cessation
treatment, and yet many smokers fail to quit using NRT. Many of these smokers may benefit
from prescription treatment alternatives, including Zyban or Chantix. In this study, the
investigators propose to develop and evaluate a stepped-care treatment algorithm that would
evaluate whether smokers who receive treatment with NRT should be supplemented with Zyban or
switched to Chantix only based on: 1) their initial response to NRT; and 2) individual
genetic factors found to predict smoking cessation in other studies evaluating these
treatments. This study is a continuation of our previous studies showing that abstinence
rates can be increased by starting nicotine patch therapy two weeks before the quit date.
The investigators will provide pre-cessation NRT to all participants initially. Those who
do not show a favorable response on early indicators of success (e. g., smoking in the first
week after the target quit-smoking date) will receive "rescue" treatment by having their NRT
treatment supplemented with Zyban , by being switched to treatment with Chantix or will
remain on NRT (control).
The investigators hypothesize that "Rescue" treatment with Zyban in combination with NRT or
Chantix will increase success rates over leaving subjects on NRT when they are NRT
insufficient responders, i. e. they have shown an unfavorable response to NRT in the first
week pre-quit or the first week post-quit.
Inclusion Criteria:
- 18-65 years old
- smoked an average of at least 10 cigarettes per day for three cumulative years of a
brand that delivers (by Federal Trade Commission rated yields) at least 0. 5mg
nicotine
- expired carbon monoxide reading of at least 15ppm
- express a desire to quit smoking in the next 30 days
Exclusion Criteria:
- Hypertension (systolic >140 mm Hg, diastolic >100 mm Hg, coupled with a history of
hypertension); subjects with no previous diagnosis of hypertension may have a
screening blood pressure up to 160/100.
- Hypotension (systolic <90 mm Hg, diastolic <60 mm Hg).
- Participants with a history of hypertension may, however, be allowed to participate
in the study if the study physician or physician assistant determines that the
condition is stable, controlled by medication, and in no way jeopardizes the
individual's safety.
- Coronary heart disease;
- Lifetime history of heart attack;
- Cardiac rhythm disorder (irregular heart rhythm);
- Chest pains (unless history, exam, and ECG clearly indicate a non-cardiac source);
- Cardiac (heart) disorder (including but not limited to valvular heart disease, heart
murmur, heart failure);
- History of skin allergy;
- Active skin disorder (e. g., psoriasis) within the last five years, except minor skin
conditions (including but not limited to facial acne, minor localized infections, and
superficial minor wounds);
- Liver or kidney disorder (except kidney stones, gallstones);
- Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;
- Active ulcers in the past 30 days;
- Lung disorder (including but not limited to COPD, emphysema, and asthma);
- Brain abnormality (including but not limited to stroke, brain tumor, and seizure
disorder);
- History of migraine headaches in the past 5 years;
- History of fainting;
- Problems giving blood samples;
- Diabetes treated with insulin; non-insulin treated diabetes (unless glucose is less
than 180mg/dcl and HbA1c is less than 7%);
- Current cancer or treatment for cancer in the past six months (except basal or
squamous cell skin cancer);
- Other major medical condition;
- Current psychiatric disease (with the exception of anxiety disorders, OCD and ADHD);
- Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted
suicide;
- Current depression - The Patient Health Questionnaire PHQ-9 for Depression will be
used to screen for current (within 2 weeks) depression. Potential subjects who score
>9 (or who score >0 on item #9 ("Thoughts that you would be better off dead, or of
hurting yourself in some way") will be excluded from study participation, and, at the
discretion of the study physician, referred to appropriate psychiatric treatment;
- Bulimia or anorexia;
- Pregnant or nursing mothers;
- Use (within the past 30 days) of:
- Illegal drugs (or if the urine drug screen is positive),
- Experimental (investigational) drugs;
- Psychiatric medications including antidepressants, anti-psychotics or any other
medications that are known to affect smoking cessation (e. g. clonidine);
- Opiate medications for pain or sleep (non-opiate medication for pain or sleep will be
allowed)
- Smokeless tobacco (chewing tobacco, snuff), cigars or pipes;
- Wellbutrin, bupropion, Zyban, Chantix, nicotine replacement therapy or any other
smoking cessation aid.
- Alcohol abuse - The AUDIT (Alcohol Use Disorders Identification Test) questionnaire
will be used to assess alcohol abuse. Potential participants will be asked the first
two questions on the AUDIT questionnaire during the phone screen. If the person
scores "4" on both questions, a screening appointment will not be scheduled. During
the screening session the entire AUDIT questionnaire will be administered. Females
who score greater than or equal to 13 and males who score greater than or equal to 15
will be excluded from the study.
- Significant adverse reaction to Wellbutrin / Zyban or Chantix / Varenicline in the
past
