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Completed

NCT Number: NCT02168855

Cessation in Non-Daily Smokers

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).

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Key information

Conditions

Smoking Behavior Health Behavior Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Smoking Research Group, University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

active nicotine gum

Drug

2 mg, standard over-the-counter nicotine replacement therapy gum

Standard Behavioral Therapy

Behavioral

Standard behavioral therapy for smoking cessation

Primary outcomes

  1. Smoking Cessation, Continuous 6-month Abstinence

    Time frame: up to week 24

    Long term abstinence assessed and biochemically validated. The results reported are the number of participants self-reporting continuous abstinence throughout the 6-month, post-quit follow-up period. To be considered abstinent, a participant must have self-reported having not smoked during this period, demonstrated carbon monoxide levels less than or equal to 3 at each study visit, and cotinine values assessed via urinalysis at levels less than or equal to 25 ng/ml.

Secondary outcomes

  1. Characteristics of Quit and Relapse Process - Craving

    Time frame: Six-week post-quit period

    Ecological Momentary Assessment (EMA) methods will be used to study the craving, withdrawal, and relapse processes among ITS and relate relapse contexts to baseline smoking patterns. This measure assessed the intensity of craving experienced by participants during their attempt to quit smoking, via self-report. To ensure the results were not influenced by the use of active nicotine replacement gum, only the participants receiving inactive gum (containing no nicotine) are included in this analysis.

    The scale's range was 0-100, with higher values reflecting higher levels of self-reported craving (maximum score of 100), whereas a score of 0 indicates no craving. "Background" craving is defined as that experienced when a participant was not smoking or feeling a temptation to smoke. "Temptations to smoke" refers to situations where a participant was tempted to smoke and did, or tempted to and did not.

  2. Characteristics of Quit and Relapse Process - Negative Affect

    Time frame: Six-week post-quit period

    Ecological Momentary Assessment (EMA) methods will be used to study the craving, withdrawal, and relapse processes among ITS and relate relapse contexts to baseline smoking patterns. This measure assesses the intensity of negative affect participants experienced during their attempt to quit smoking. To ensure the results were not influenced by the use of active nicotine replacement gum, only the participants receiving inactive gum (containing no nicotine) are included in this analysis.

    The scale's range was 0-100, with higher values reflecting higher levels of self-reported negative affect (maximum score of 100), whereas a score of 0 would indicate no negative affect. 50 indicates the population mean with a standard deviation of 10. "Background" reports are defined as those experienced when a participant was not smoking or feeling a temptation to smoke. "Temptations to smoke" refers to situations where a participant was tempted to smoke and did, or tempted to and did not.

  3. Characteristics of Quit and Relapse Process - Saw No Smoking Cues

    Time frame: Six-week post-quit period

    Ecological Momentary Assessment (EMA) methods will be used to study the craving, withdrawal, and relapse processes among ITS and relate relapse contexts to baseline smoking patterns.To ensure the results were not influenced by the use of active nicotine replacement gum, only the participants receiving inactive gum (containing no nicotine) are included in this analysis.

    This measure reports the percentage of instances during which participants were not exposed to physical cues to smoke, such as cigarettes, ashtrays, or lighters), when experiencing temptations to smoke compared to experiencing no temptations to smoke. "Background" reports are defined as those experienced when a participant was not smoking or feeling a temptation to smoke. "Temptations to smoke" refers to situations where a participant was tempted to smoke and did, or tempted to and did not.

  4. Characteristics of Quit and Relapse Process - No Others Smoking Nearby

    Time frame: Six-week post-quit period

    Ecological Momentary Assessment (EMA) methods will be used to study the craving, withdrawal, and relapse processes among ITS and relate relapse contexts to baseline smoking patterns. To ensure the results were not influenced by the use of active nicotine replacement gum, only the participants receiving inactive gum (containing no nicotine) are included in this analysis.

    This measure reports the percentage of instances during which participants were not exposed to others smoking nearby, when experiencing temptations to smoke compared to experiencing no temptations to smoke. "Background" reports are defined as those experienced when a participant was not smoking or feeling a temptation to smoke. "Temptations to smoke" refers to situations where a participant was tempted to smoke and did, or tempted to and did not.

Sponsors and collaborators

Lead sponsor

Brian Primack

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Cessation in Non-Daily Smokers: A RCT of NRT With Ecological Momentary Assessment

Acronym: QUITS

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 20, 2014
Registry last updated
May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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