The Long-Term Quitting (Smoking Cessation) Study

This study aims to identify effective Relapse Recovery (RR) treatments to assist smokers who
relapse after an initial quit attempt. The study will use a sequential, multiple assignment,
randomized trial (SMART) design with three phases. In a SMART design, randomization occurs at
more than one stage, with randomization at a later stage based on response to treatment at an
earlier stage. The three phases in this SMART study are as follows:

1. Phase 1 consists of the Quit Phase in which all participants (smokers motivated to quit
smoking) will be offered evidence-based cessation treatment (cessation medication plus
counseling). Participants who relapse will be eligible to proceed to the next phase
which involves Relapse Recovery (RR) Preparation treatment.

2. Phase 2 consists of RR Preparation Phase treatments in which relapsed participants from
the Quit Phase will be randomized to three arms: (a) Recycling Counseling (where
participants are encouraged to quit again as soon as possible); (b) Behavioral Reduction
Counseling + Nicotine Mini-Lozenge (which targets smoking reduction and preparation for
a new quit attempt); and (c) Preparation Phase Control (continuation of Quit Phase
treatment plus advice to seek additional help from the Wisconsin Tobacco Quit Line or
their clinic care provider).

3. Phase 3 consists of RR Cessation Phase treatments in which non-control (i.e. Recycling
or Behavioral Reduction) Preparation Phase participants who elect to make a new quit
attempt will be randomized to one of four treatment conditions in a 2X2 fully-crossed
factorial design: (a) Supportive Counseling + Skill Training; (b) Supportive Counseling
+ Brief Information; (c) Skill Training + Brief Information; and (d) Brief Information
Only. All participants will receive 8 weeks of combination nicotine replacement therapy
(Nicotine Patch + Nicotine Mini-Lozenge). Brief Information will consist of generic
information about the importance of taking the medication and how to use it, information
about side effects/safety and what to do in case of problems, and participants will also
be given encouragement.

Smoking status will be assessed 14 months after randomization to RR Preparation Phase
treatment. The investigators hypothesize that 7-day point point-prevalence abstinence rates
will be 15% for the Preparation Phase Control condition, 25% for the Recycling condition, and
35% for the Behavioral Reduction condition. The investigators propose that any increase in
abstinence of 15% or higher would be clinically significant. The investigators did not power
the study to demonstrate a significant difference between the two active RR Preparation Phase
treatments. Therefore, the investigators anticipate that only the RR Behavioral Reduction
treatment will significantly increase long-term abstinence rates (primary outcome:
Biochemically-confirmed 7-Day Point Prevalence Abstinence at 14 Months post-randomization to
Phase 2 Preparation treatment) over those produced by the Preparation Phase Control
condition. Because of limitations in statistical power, analyses of RR Cessation Phase
treatments will be exploratory only (secondary outcome: Self-Reported 7-Day Point Prevalence
Abstinence at 26 Weeks post-randomization to Phase 3 Cessation treatment).

Inclusion Criteria:

1. age >=18 years,

2. smoking >4 cigarettes/day for the previous 6 months,

3. able to read, write, and speak English,

4. have reliable phone access and agree to respond to Interactive Voice Response (IVR)
phone prompts, and

5. if currently using NRT, agreeing to use only study medication for the duration of the
study, we will not exclude participants based on their prior use of cessation
medication or if they use multiple tobacco products in order to enhance real-world
generalization (these will be statistically controlled in analyses),

6. motivation to quit smoking, and

7. planning to remain in the intervention catchment area for at least 2 years and 2
months, .

Exclusion Criteria:

1. Currently taking bupropion or varenicline,

2. unwillingness to cease other forms of nicotine replacement or Chantix (also called
Varenicline),

3. medical contraindications to using NRT including hospitalized (for at least one night)
for a stroke, heart attack, congestive heart failure or diabetes in the last 4 weeks,
history of a serious skin or allergic reaction to using the Nicotine patch,

4. diagnosis of or treatment for schizophrenia, a psychotic disorder or bipolar disorder
in the last 10 years and,

5. if the participant is a woman of childbearing potential, being pregnant or intending
to becoming pregnant or unwillingness to use an approved method of birth control
during treatment.