This study is designed to test an adaptive pharmacotherapy algorithm within the Duke Smoking
Cessation Program (DSCP). The investigators hypothesize that patients treated in the DSCP
with Algorithm-based pharmacotherapy vs. Varenicline will show significantly higher 12-week
post-quit 30-day continuous abstinence.
This research study is a cross-randomized, placebo-controlled trial to evaluate an
algorithm-based pharmacotherapy approach to treating tobacco use ('Algorithm') and the
efficacy of a high intensity behavioral treatment in comparison to the standard of care. The
Algorithm is designed to assist clinicians in identifying the appropriate pharmacotherapy
and behavioral interventions to treat tobacco use and to provide additional medications to
individuals who do not decrease tobacco use following two weeks of pre-quit pharmacotherapy
('Non-Responders'). The population group is recruited from patients being seen at the Duke
Smoking Cessation Program. Outcomes of abstinence variables will be analyzed using general
regression models using an ANOVA-based design; randomization status to both pharmacotherapy
and behavioral groups will be denoted using a proxy variable to test primary study effects.
An alpha criterion of 0.05 (two-tailed) will be used in all comparisons. Risk for the study
is low as all pharmacotherapies being evaluated are FDA-approved for tobacco use treatment.
Participants being screened are being treated at the Translational Smoking Cessation
Program (TSCP). Practically speaking, however, the TSCP will only be treating patients who
have self-reported as smokers, who are 18 years of age or older, and who would like to
1. Patient being treated at DSCP for tobacco use
2. Age 18 years or older
3. Actively smoking 5 or more cigarettes per day for at least one year
4. Fluency in spoken and written English
5. Willing to set a quit date within 6 weeks
6. Access to a telephone
7. Willingness to attend 7 weeks (24 hours) of group therapy on specific offered dates.
8. Willingness to take Varenicline, Bupropion and Nicotine Patch.
1. CO test under 7 ppm
2. 8 or above on the Alcohol Use Disorders Identification Test (AUDIT-10)
3. 6 or above on Drug Abuse Screening Test (DAST-10)
4. 3 or above on Patient Health Questionnaire (PHQ-2) Depression Scale
5. Daily use of a second form of tobacco or nicotine (e.g. e-cigarettes, cigars, chewing
6. Current use of a smoking cessation medication (e.g. nicotine replacement,
7. Intolerable side effects related to, refusal to take, or medical contraindication to
the use of Varenicline, nicotine patch, or Bupropion.
8. Symptomatic cognitive or emotive disorder such as untreated schizophrenia, severe
untreated depression, anxiety. This is determined by clinical assessment.
9. Disruptive behavior toward staff. Because subjects are requested to engage in group
behavioral treatment, this criterion is for the protection of other participants
within group treatment.
10. Report of pregnancy, attempting to get pregnant, or actively breast feeding.
11. Positive urine pregnancy test (only given to females with child bearing potential)