Cessation in Non-Daily Smokers

Study Overview
=================
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.

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

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Drug: active nicotine gum
* Behavioral: Standard behavioral therapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smoking cessation, Non-daily smokers, Ecological Momentary Assessment, nicotine replacement therapy