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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active nicotine gum | Active Comparator |
| |
| Inactive gum | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active nicotine gum | Drug | 2 mg, standard over-the-counter nicotine replacement therapy gum |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian A Primack, MD, PhD | University of Pittsburgh, Division of General Internal Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Smoking Research Group, University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
While 505 participants were enrolled in and began the study, only 369 of these were ultimately randomized to the active nicotine gum or inactive (placebo) gum arms. Those who were not randomized due to either participant-initiated drop out (n=36), research-team-initiated withdrawal due to noncompliance (n=83), or loss to followup (n=17).
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Nicotine Gum | active nicotine gum: 2 mg, standard over-the-counter nicotine replacement therapy gum Standard behavioral therapy: Standard behavioral therapy for smoking cessation |
| FG001 | Inactive Gum | Standard behavioral therapy: Standard behavioral therapy for smoking cessation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Nicotine Gum | active nicotine gum: 2 mg, standard over-the-counter nicotine replacement therapy gum Standard behavioral therapy: Standard behavioral therapy for smoking cessation |
| BG001 | Inactive Gum |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | up to week 24 |
|
Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months.
Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Nicotine Gum | active nicotine gum: 2 mg, standard over-the-counter nicotine replacement therapy gum Standard behavioral therapy: Standard behavioral therapy for smoking cessation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for gastrointestinal viral infection | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric upset | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Primack | University of Arkansas | 479-575-3208 | bprimack@uark.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 8, 2019 | Jan 9, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 2, 2016 | Jan 22, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| Standard behavioral therapy | Behavioral | Standard behavioral therapy for smoking cessation |
|
| 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 |
Standard behavioral therapy: Standard behavioral therapy for smoking cessation
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Cigarettes smoked per day on average, assessed over the last 28 days, including all days | Collected via self-reported "time-line follow-back" calendar, in which participants reported on each day in the previous 28 days the number of cigarettes they smoked. The average is calculated as the number of cigarettes smoked per days, including each day of the previous 28 days in the denominator, regardless of whether the participant reported smoking on each of those days. In other words, if a participant reported smoking on only 4 of the past 28 days, the average would be calculated by adding the total number of cigarettes smoked on those 4 days and dividing that number by 28. | Mean | Standard Deviation | cigarettes per day |
|
| Cigarettes smoked per day on average, assessed over the last 28 days, including only smoking days | Collected via self-reported "time-line follow-back" calendar, in which participants reported on each day in the previous 28 days the number of cigarettes they smoked. The average is then calculated, to arrive at this measure - the number of cigarettes smoked per day, at baseline, including in the denominator only the number of days the participant reported having smoked. In other words, if a participant reported smoking on only 4 of the past 28 days, the average would be calculated by adding the total number of cigarettes smoked on those 4 days, and dividing that number by 4. | Mean | Standard Deviation | cigarettes per day |
|
Standard behavioral therapy: Standard behavioral therapy for smoking cessation |
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|
|
| Secondary | 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. | This is the subset of placebo arm ITS participants who had achieved initial abstinence. These participants all submitted at least one background and one temptation report. To ensure the results were not influenced by using active nicotine gum, only participants receiving inactive gum (containing no nicotine) are included in this analysis. | Posted | Least Squares Mean | Standard Error | score on a scale | Six-week post-quit period |
|
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|
|
| Secondary | 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. | This is the subset of placebo arm ITS participants who had achieved initial abstinence. These participants all submitted at least one background and one temptation report. To ensure the results were not influenced by using active nicotine gum, only participants receiving inactive gum (containing no nicotine) are included in this analysis. | Posted | Least Squares Mean | Standard Error | T-score | Six-week post-quit period |
|
|
|
|
| Secondary | 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. | This is the subset of placebo arm ITS participants who had achieved initial abstinence. These participants all submitted at least one background and one temptation report. To ensure the results were not influenced by using active nicotine gum, only participants receiving inactive gum (containing no nicotine) are included in this analysis. | Posted | Number | percentage of assessments | Six-week post-quit period |
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|
|
| Secondary | 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. | This is the subset of placebo arm ITS participants who had achieved initial abstinence. These participants all submitted at least one background and one temptation report. To ensure the results were not influenced by using active nicotine gum, only participants receiving inactive gum (containing no nicotine) are included in this analysis. | Posted | Number | percentage of assessments | Six-week post-quit period |
|
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|
| 0 |
| 181 |
| 9 |
| 181 |
| 93 |
| 181 |
| EG001 | Inactive Gum | Standard behavioral therapy: Standard behavioral therapy for smoking cessation | 0 | 188 | 14 | 188 | 65 | 188 |
| Hospitalization for pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Foot surgery | Surgical and medical procedures | Non-systematic Assessment |
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| Surgery for Appendicitis | Surgical and medical procedures | Systematic Assessment |
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| Hemorrhoidectomy | Surgical and medical procedures | Systematic Assessment |
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| Hospitalization for lupus flare-up | Immune system disorders | Systematic Assessment |
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| Hospitalization for GERD flare-up | Gastrointestinal disorders | Systematic Assessment |
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| Surgery on ovaries | Surgical and medical procedures | Systematic Assessment |
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| Worsening of degenerative disc disease | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hospitalization for wrist injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Carpal tunnel surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Root canal | Surgical and medical procedures | Systematic Assessment |
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| Hospitalization for after car accident | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hospitalization for high blood pressure | Vascular disorders | Systematic Assessment |
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| Worsening of lung disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Broken hip | Injury, poisoning and procedural complications | Systematic Assessment |
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| Breast cancer | Reproductive system and breast disorders | Systematic Assessment |
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| Hospitalization for allergic skin reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hospitalization for thyroid disorder | Endocrine disorders | Systematic Assessment |
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| Corneal implant surgery | Eye disorders | Systematic Assessment |
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| Weight gain | Metabolism and nutrition disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Irritability | General disorders | Systematic Assessment |
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| Throat or mouth irritation | General disorders | Systematic Assessment |
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