Clinical trial NCT02168855: Cessation in Non-Daily Smokers
Official title: Cessation in Non-Daily Smokers: A RCT of NRT With Ecological Momentary Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Smoking cessation
Non-daily smokers
Ecological Momentary Assessment
nicotine replacement therapy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2014-06-20
Enrollment: 505
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Smoking Cessation, Continuous 6-month Abstinence
timeFrame: up to week 24
Secondary outcomes:
measure: Characteristics of Quit and Relapse Process - Craving
timeFrame: Six-week post-quit period
measure: Characteristics of Quit and Relapse Process - Negative Affect
timeFrame: Six-week post-quit period
measure: Characteristics of Quit and Relapse Process - Saw No Smoking Cues
timeFrame: Six-week post-quit period
measure: Characteristics of Quit and Relapse Process - No Others Smoking Nearby
timeFrame: Six-week post-quit period
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Smoking Research Group, University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh, Division of General Internal Medicine
name: Brian A Primack, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: