Trial · NCT02168855
Cessation in Non-Daily Smokers
NCT02168855, Not applicable, Completed, Brian Primack; results first posted 2020-05-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cessation in Non-Daily Smokers. Trials, record NCT02168855. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02168855
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cessation in Non-Daily Smokers
- NCT number
- NCT02168855
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 505 participants, actual
- Lead sponsor
- Brian Primack
- Conditions
- Smoking
- Interventions
- active nicotine gum, Standard behavioral therapy
- First posted
- 2014-06-20
- Last updated
- 2020-05-06
- Results first posted
- 2020-05-06
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Smoking Cessation, Continuous 6-month Abstinence | up to week 24 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Characteristics of Quit and Relapse Process - Craving | Six-week post-quit period | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Characteristics of Quit and Relapse Process - Negative Affect | Six-week post-quit period | 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. | T-score | LEAST_SQUARES_MEAN |
| SECONDARY | Characteristics of Quit and Relapse Process - Saw No Smoking Cues | Six-week post-quit period | 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. | percentage of assessments | NUMBER |
| SECONDARY | Characteristics of Quit and Relapse Process - No Others Smoking Nearby | Six-week post-quit period | 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. | percentage of assessments | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Smoking Cessation, Continuous 6-month Abstinence | Active Nicotine Gum | 13 | Participants | ||
| Smoking Cessation, Continuous 6-month Abstinence | Inactive Gum | 10 | Participants | ||
| Characteristics of Quit and Relapse Process - Craving | Inactive Gum | Background | 16.68 | Standard Error 1.61 | score on a scale |
| Characteristics of Quit and Relapse Process - Craving | Inactive Gum | Temptations to smoke | 57.09 | Standard Error 2.50 | score on a scale |
| Characteristics of Quit and Relapse Process - Negative Affect | Inactive Gum | Background | 49.13 | Standard Error 0.63 | T-score |
| Characteristics of Quit and Relapse Process - Negative Affect | Inactive Gum | Temptations to smoke | 51.96 | Standard Error 0.84 | T-score |
| Characteristics of Quit and Relapse Process - Saw No Smoking Cues | Background | Background | 83.64 | percentage of assessments | |
| Characteristics of Quit and Relapse Process - Saw No Smoking Cues | Background | Temptations to smoke | 59.11 | percentage of assessments | |
| Characteristics of Quit and Relapse Process - No Others Smoking Nearby | Background | Background | 90.42 | percentage of assessments | |
| Characteristics of Quit and Relapse Process - No Others Smoking Nearby | Background | Temptations to smoke | 66.82 | percentage of assessments |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Active Nicotine Gum | 181 | |
| Overall Study | STARTED | Inactive Gum | 188 | |
| Overall Study | COMPLETED | Active Nicotine Gum | 169 | |
| Overall Study | COMPLETED | Inactive Gum | 177 | |
| Overall Study | NOT COMPLETED | Active Nicotine Gum | 12 | |
| Overall Study | NOT COMPLETED | Inactive Gum | 11 |
Source ClinicalTrials.gov
Adverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gastric upset | Gastrointestinal disorders | Active Nicotine Gum | 28 | 181 | 28 |
| other | Gastric upset | Gastrointestinal disorders | Inactive Gum | 13 | 188 | 13 |
| other | Weight gain | Metabolism and nutrition disorders | Active Nicotine Gum | 14 | 181 | 14 |
| other | Weight gain | Metabolism and nutrition disorders | Inactive Gum | 15 | 188 | 15 |
| other | Headache | General disorders | Active Nicotine Gum | 15 | 181 | 15 |
| other | Headache | General disorders | Inactive Gum | 13 | 188 | 13 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Active Nicotine Gum | 10 | 181 | 10 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Inactive Gum | 14 | 188 | 14 |
| other | Irritability | General disorders | Active Nicotine Gum | 13 | 181 | 13 |
| other | Irritability | General disorders | Inactive Gum | 7 | 188 | 7 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Active Nicotine Gum | 0 | 181 |
| Total, all-cause mortality | Inactive Gum | 0 | 188 |
| Total, other adverse events | Active Nicotine Gum | 93 | 181 |
| Total, other adverse events | Inactive Gum | 65 | 188 |
| Total, serious adverse events | Active Nicotine Gum | 9 | 181 |
| Total, serious adverse events | Inactive Gum | 14 | 188 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DA034629 | Cessation in Non-Daily Smokers: A RCT of NRT with Ecological Momentary Assessment | PRIMACK, BRIAN A.; TINDLE, HILARY A. | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL INSTITUTE ON DRUG ABUSE | 2013 to 2018 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Active Nicotine Gum vs Inactive Gum: Smoking Cessation, Continuous 6-month Abstinence | Trial comparisons |
| Active Nicotine Gum vs Inactive Gum: deaths from any cause | Trial comparisons |
| Active Nicotine Gum vs Inactive Gum: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02168855
GET https://conductscience.org/api/trials/v1/NCT02168855/events?page=2