Cessation in Non-Daily Smokers

Our aim is to study the effect of as-needed oral Nicotine Replacement Therapy (NRT) - 2 mg
nicotine gum - for smoking cessation in non-daily, or intermittent, smokers (ITS), and to
study the process of relapse in ITS, using Ecological Momentary Assessment (EMA). This is a
double-blind, randomized, placebo-controlled trial of oral NRT for smoking cessation in ITS.
600 ITS who are interested in quitting will be recruited through multiple channels. Enrollees
will be randomized 1:1 to active 2 mg nicotine gum or an inert control gum. Participants will
attend 6 sessions with brief behavioral support, with a planned quit day at week 2. Short and
long term abstinence will be assessed and biochemically validated. EMA data collection
includes two weeks of baseline data on ad lib smoking patterns and 6 weeks of post-quit data.
This will capture data on craving, withdrawal, and relapse among ITS, and relate relapse
contexts to baseline smoking patterns.

Inclusion Criteria:

- 18 years old or older

- Smoking for at least 3 years

- Smoking non-daily for at least one year (< or = 27 days/month)

- Smoke at least weekly

- Intention to quit smoking within the next month and a desire to receive behavioral and
medication treatment

- Willing and able to come to the laboratory for 8 visits over a 14-week period, as well
as a ninth and final visit 6 months after their quit date

- Willing to monitor behavior via an electronic diary for 8 weeks

- Able to read and write English (in order to understand questionnaires and study
instructions)

Exclusion Criteria:

- Regular use of any form of tobacco other than cigarettes

- Recent or severe mental illness (uncontrolled severe depression or mood symptoms,
active hallucinations, and or hospitalization in the past month for a psychiatric
condition)

- Night and/or 'swing' shift work (which complicates EMA schedules)

- Known plans to relocate or move from the Pittsburgh area within the coming 6 months

- Received cessation treatment within past year

- Use of bupropion or varenicline in past 2 months

- Past use of nicotine gum (to avoid un-blinding)

- Contraindication to NRT

- (for women) Current pregnancy or breastfeeding or plan to become pregnant during the
next 2 months

- Member of the same household already participating