Smoking
Conditions
Keywords
Smoking cessation, Non-daily smokers, Ecological Momentary Assessment, nicotine replacement therapy
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.
Interventions
DRUGactive nicotine gum
2 mg, standard over-the-counter nicotine replacement therapy gum
BEHAVIORALStandard behavioral therapy
Standard behavioral therapy for smoking cessation
Sponsors
National Institute on Drug Abuse (NIDA)
Brian Primack
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Cessation, Continuous 6-month Abstinence | 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
| Measure | Time frame | Description |
|---|---|---|
| Characteristics of Quit and Relapse Process - Craving | 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. |
| Characteristics of Quit and Relapse Process - Negative Affect | 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. |
| Characteristics of Quit and Relapse Process - Saw No Smoking Cues | 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. |
| Characteristics of Quit and Relapse Process - No Others Smoking Nearby | 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. |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 181 |
| Inactive Gum Standard behavioral therapy: Standard behavioral therapy for smoking cessation | 188 |
| Total | 369 |
Baseline characteristics
| Characteristic | Inactive Gum | Active Nicotine Gum | Total |
|---|---|---|---|
| Age, Continuous | 45.87 years STANDARD_DEVIATION 15.02 | 42.72 years STANDARD_DEVIATION 13.76 | 44.32 years STANDARD_DEVIATION 14.48 |
| Cigarettes smoked per day on average, assessed over the last 28 days, including all days | 1.9 cigarettes per day STANDARD_DEVIATION 1.5 | 1.8 cigarettes per day STANDARD_DEVIATION 1.5 | 1.9 cigarettes per day STANDARD_DEVIATION 1.5 |
| Cigarettes smoked per day on average, assessed over the last 28 days, including only smoking days | 3.9 cigarettes per day STANDARD_DEVIATION 2.9 | 3.3 cigarettes per day STANDARD_DEVIATION 2 | 3.6 cigarettes per day STANDARD_DEVIATION 2.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 11 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 179 Participants | 170 Participants | 349 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 81 Participants | 67 Participants | 148 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 11 Participants | 19 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) White | 93 Participants | 94 Participants | 187 Participants |
| Sex: Female, Male Female | 102 Participants | 108 Participants | 210 Participants |
| Sex: Female, Male Male | 86 Participants | 73 Participants | 159 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 181 | 0 / 188 |
| other Total, other adverse events | 93 / 181 | 65 / 188 |
| serious Total, serious adverse events | 9 / 181 | 14 / 188 |
Outcome results
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.
Time frame: up to week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Nicotine Gum | Smoking Cessation, Continuous 6-month Abstinence | 13 Participants |
| Inactive Gum | Smoking Cessation, Continuous 6-month Abstinence | 10 Participants |
p-value: 0.4695% CI: [0.58, 3.29]Regression, Logistic
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.
Time frame: Six-week post-quit period
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Active Nicotine Gum | Characteristics of Quit and Relapse Process - Craving | Background | 16.68 score on a scale | Standard Error 1.61 |
| Active Nicotine Gum | Characteristics of Quit and Relapse Process - Craving | Temptations to smoke | 57.09 score on a scale | Standard Error 2.5 |
p-value: <0.000195% CI: [1.83, 1.98]Mixed Models Analysis
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.
Time frame: Six-week post-quit period
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Active Nicotine Gum | Characteristics of Quit and Relapse Process - Negative Affect | Background | 49.13 T-score | Standard Error 0.63 |
| Active Nicotine Gum | Characteristics of Quit and Relapse Process - Negative Affect | Temptations to smoke | 51.96 T-score | Standard Error 0.84 |
p-value: <0.000195% CI: [1.51, 1.83]Mixed Models Analysis
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.
Time frame: Six-week post-quit period
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active Nicotine Gum | Characteristics of Quit and Relapse Process - No Others Smoking Nearby | Background | 90.42 percentage of assessments |
| Active Nicotine Gum | Characteristics of Quit and Relapse Process - No Others Smoking Nearby | Temptations to smoke | 66.82 percentage of assessments |
p-value: <0.000195% CI: [0.15, 0.23]Regression, Logistic
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.
Time frame: Six-week post-quit period
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active Nicotine Gum | Characteristics of Quit and Relapse Process - Saw No Smoking Cues | Background | 83.64 percentage of assessments |
| Active Nicotine Gum | Characteristics of Quit and Relapse Process - Saw No Smoking Cues | Temptations to smoke | 59.11 percentage of assessments |
p-value: <0.000195% CI: [0.14, 0.21]Regression, Logistic