Cessation in Non-Daily Smokers (QUITS)

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

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).

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Drug: active nicotine gum; Behavioral: Standard behavioral therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 505
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Smoking Research Group, University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active nicotine gum	Drug: active nicotine gum; 2 mg, standard over-the-counter nicotine replacement therapy gum; Behavioral: Standard behavioral therapy; Standard behavioral therapy for smoking cessation
Placebo Comparator: Inactive gum	Behavioral: Standard behavioral therapy; Standard behavioral therapy for smoking cessation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Cessation, Continuous 6-month Abstinence	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.	up to week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characteristics of Quit and Relapse Process - Craving	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.	Six-week post-quit period
Characteristics of Quit and Relapse Process - Negative Affect	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.	Six-week post-quit period
Characteristics of Quit and Relapse Process - Saw No Smoking Cues	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.	Six-week post-quit period
Characteristics of Quit and Relapse Process - No Others Smoking Nearby	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.	Six-week post-quit period

Collaborators and Investigators

• Sponsor: Brian Primack
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Brian A Primack, MD, PhD, University of Pittsburgh, Division of General Internal Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: June 18, 2014
• First Submitted That Met QC Criteria: June 19, 2014
• First Posted (Estimate): June 20, 2014

Study Record Updates

• Last Update Posted (Actual): May 6, 2020
• Last Update Submitted That Met QC Criteria: April 24, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Smoking cessation; nicotine replacement therapy; Ecological Momentary Assessment; Non-daily smokers
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 1R01DA034629 (U.S. NIH Grant/Contract)