Cessation in Non-Daily Smokers (QUITS)

Brian Primack

Status

Completed

Conditions

Smoking

Treatments

Behavioral: Standard behavioral therapy

Drug: active nicotine gum

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02168855

1R01DA034629

Details and patient eligibility

About

The purpose of this study is to examine the effect of as-needed oral Nicotine Replacement Therapy (NRT) - 2 mg nicotine gum - for smoking cessation in non-daily, or intermittent, smokers, and to study the process of relapse in ITS, using Ecological Momentary Assessment (EMA).

Full description

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.

Enrollment

505 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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