Trial Outcomes & Findings for Smartphone Based Smoking Cessation Intervention (NCT NCT03740490)
NCT ID: NCT03740490
Last Updated: 2025-08-17
Results Overview
Biochemically confirmed 7-day point prevalence abstinence using the CO criteria cutoff of ≤ 6 ppm
COMPLETED
PHASE2/PHASE3
454 participants
27 Weeks
2025-08-17
Participant Flow
Participant milestones
| Measure |
Smart-T + NRT
Smart-T provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. The Smart-T app contains multiple components including an EMA delivery and data transfer system, automated messages based upon EMA responses, and on-demand content. All participants will receive free nicotine replacement therapy (NRT).
Smart-T + NRT: Smart-Treatment App and Nicotine Replacement Therapy
|
NCI QuitGuide + NRT
The National Cancer Institute's QuitGuide app is a free smartphone app and is one of few apps that includes many of the recommendations detailed in the Clinical Practice Guideline. The QuitGuide app aims to help smokers understand their smoking patterns and develop the skills needed to quit smoking. QuitGuide provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. All participants will receive free nicotine replacement therapy (NRT).
QuitGuide + NRT: NCI QuitGuide Treatment App and Nicotine Replacement Therapy
|
|---|---|---|
|
Overall Study
STARTED
|
225
|
229
|
|
Overall Study
COMPLETED
|
170
|
183
|
|
Overall Study
NOT COMPLETED
|
55
|
46
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Smartphone Based Smoking Cessation Intervention
Baseline characteristics by cohort
| Measure |
Smart-T + NRT
n=225 Participants
Smart-T provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. The Smart-T app contains multiple components including an EMA delivery and data transfer system, automated messages based upon EMA responses, and on-demand content. All participants will receive free nicotine replacement therapy (NRT).
Smart-T + NRT: Smart-Treatment App and Nicotine Replacement Therapy
|
NCI QuitGuide + NRT
n=229 Participants
The National Cancer Institute's QuitGuide app is a free smartphone app and is one of few apps that includes many of the recommendations detailed in the Clinical Practice Guideline. The QuitGuide app aims to help smokers understand their smoking patterns and develop the skills needed to quit smoking. QuitGuide provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. All participants will receive free nicotine replacement therapy (NRT).
QuitGuide + NRT: NCI QuitGuide Treatment App and Nicotine Replacement Therapy
|
Total
n=454 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
52.0 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
52.0 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
166 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
333 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
215 Participants
n=5 Participants
|
226 Participants
n=7 Participants
|
441 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
52 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
143 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
289 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 27 WeeksBiochemically confirmed 7-day point prevalence abstinence using the CO criteria cutoff of ≤ 6 ppm
Outcome measures
| Measure |
Smart-T + NRT
n=225 Participants
Smart-T provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. The Smart-T app contains multiple components including an EMA delivery and data transfer system, automated messages based upon EMA responses, and on-demand content. All participants will receive free nicotine replacement therapy (NRT).
Smart-T + NRT: Smart-Treatment App and Nicotine Replacement Therapy
|
NCI QuitGuide + NRT
n=229 Participants
The National Cancer Institute's QuitGuide app is a free smartphone app and is one of few apps that includes many of the recommendations detailed in the Clinical Practice Guideline. The QuitGuide app aims to help smokers understand their smoking patterns and develop the skills needed to quit smoking. QuitGuide provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. All participants will receive free nicotine replacement therapy (NRT).
QuitGuide + NRT: NCI QuitGuide Treatment App and Nicotine Replacement Therapy
|
|---|---|---|
|
Biochemically-Verified Smoking Cessation
|
37 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 27 weeksPopulation: Mean difference in smoking urge change score between treatment groups (Smart-T vs. QuitGuide), based on a mixed-effects regression model. Confidence interval reflects the model-estimated difference between groups, not within-group means.
Urge was assessed using a single ecological momentary assessment (EMA) question: "I feel the urge to smoke." Participants rated this item on a 5-point Likert scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). Change scores were calculated by subtracting the pre-message rating from the post-message rating for each prompt. The possible range for the change score is -4 to +4. Higher scores indicate an increase in urge to smoke (worse outcome).
Outcome measures
| Measure |
Smart-T + NRT
n=216 Participants
Smart-T provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. The Smart-T app contains multiple components including an EMA delivery and data transfer system, automated messages based upon EMA responses, and on-demand content. All participants will receive free nicotine replacement therapy (NRT).
Smart-T + NRT: Smart-Treatment App and Nicotine Replacement Therapy
|
NCI QuitGuide + NRT
n=220 Participants
The National Cancer Institute's QuitGuide app is a free smartphone app and is one of few apps that includes many of the recommendations detailed in the Clinical Practice Guideline. The QuitGuide app aims to help smokers understand their smoking patterns and develop the skills needed to quit smoking. QuitGuide provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. All participants will receive free nicotine replacement therapy (NRT).
QuitGuide + NRT: NCI QuitGuide Treatment App and Nicotine Replacement Therapy
|
|---|---|---|
|
Change in Urge to Quit Smoking
|
0.053 Score on a scale
Standard Deviation 0.243
|
0.017 Score on a scale
Standard Deviation 0.232
|
SECONDARY outcome
Timeframe: 27 weeksPopulation: Mean difference in stress change score between treatment groups (Smart-T vs. QuitGuide), based on a mixed-effects regression model. Confidence interval reflects the model-estimated difference between groups, not within-group means.
Stress was assessed using a single ecological momentary assessment (EMA) question: "I feel stressed." Participants rated this item on a 5-point Likert scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). Change scores were calculated by subtracting the pre-message rating from the post-message rating for each prompt. The possible range for the change score is -4 to +4. Higher scores indicate an increase in stress (worse outcome).
Outcome measures
| Measure |
Smart-T + NRT
n=216 Participants
Smart-T provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. The Smart-T app contains multiple components including an EMA delivery and data transfer system, automated messages based upon EMA responses, and on-demand content. All participants will receive free nicotine replacement therapy (NRT).
Smart-T + NRT: Smart-Treatment App and Nicotine Replacement Therapy
|
NCI QuitGuide + NRT
n=220 Participants
The National Cancer Institute's QuitGuide app is a free smartphone app and is one of few apps that includes many of the recommendations detailed in the Clinical Practice Guideline. The QuitGuide app aims to help smokers understand their smoking patterns and develop the skills needed to quit smoking. QuitGuide provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. All participants will receive free nicotine replacement therapy (NRT).
QuitGuide + NRT: NCI QuitGuide Treatment App and Nicotine Replacement Therapy
|
|---|---|---|
|
Change in Stress
|
-0.005 Score on a scale
Standard Deviation 0.164
|
-0.031 Score on a scale
Standard Deviation 0.193
|
SECONDARY outcome
Timeframe: 27 weeksPopulation: Mean difference in cigarette availability change score between treatment groups (Smart-T vs. QuitGuide), based on a mixed-effects regression model. Confidence interval reflects the model-estimated difference between groups, not within-group means.
Perceived cigarette availability was assessed using a single ecological momentary assessment (EMA) question: "Cigarettes are available to me right now." Participants rated this item on a 5-point Likert scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). Change scores were calculated by subtracting the pre-message rating from the post-message rating for each prompt. The possible range for the change score is -4 to +4. Higher scores indicate an increase in perceived cigarette availability (worse outcome).
Outcome measures
| Measure |
Smart-T + NRT
n=216 Participants
Smart-T provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. The Smart-T app contains multiple components including an EMA delivery and data transfer system, automated messages based upon EMA responses, and on-demand content. All participants will receive free nicotine replacement therapy (NRT).
Smart-T + NRT: Smart-Treatment App and Nicotine Replacement Therapy
|
NCI QuitGuide + NRT
n=220 Participants
The National Cancer Institute's QuitGuide app is a free smartphone app and is one of few apps that includes many of the recommendations detailed in the Clinical Practice Guideline. The QuitGuide app aims to help smokers understand their smoking patterns and develop the skills needed to quit smoking. QuitGuide provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. All participants will receive free nicotine replacement therapy (NRT).
QuitGuide + NRT: NCI QuitGuide Treatment App and Nicotine Replacement Therapy
|
|---|---|---|
|
Change in Perceived Cigarette Availability
|
0.011 Score on a scale
Standard Deviation 0.181
|
-0.010 Score on a scale
Standard Deviation 0.116
|
SECONDARY outcome
Timeframe: 27 weeksPopulation: Mean difference in cessation motivation change score between treatment groups (Smart-T vs. QuitGuide), based on a mixed-effects regression model. Confidence interval reflects the model-estimated difference between groups, not within-group means.
Motivation to quit smoking was assessed using a single ecological momentary assessment (EMA) question: "I want to quit smoking." Participants rated this item on a 5-point Likert scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). Change scores were calculated by subtracting the pre-message rating from the post-message rating for each prompt. The possible range for the change score is -4 to +4. Higher scores indicate an increase in motivation to quit smoking (better outcome).
Outcome measures
| Measure |
Smart-T + NRT
n=216 Participants
Smart-T provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. The Smart-T app contains multiple components including an EMA delivery and data transfer system, automated messages based upon EMA responses, and on-demand content. All participants will receive free nicotine replacement therapy (NRT).
Smart-T + NRT: Smart-Treatment App and Nicotine Replacement Therapy
|
NCI QuitGuide + NRT
n=220 Participants
The National Cancer Institute's QuitGuide app is a free smartphone app and is one of few apps that includes many of the recommendations detailed in the Clinical Practice Guideline. The QuitGuide app aims to help smokers understand their smoking patterns and develop the skills needed to quit smoking. QuitGuide provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. All participants will receive free nicotine replacement therapy (NRT).
QuitGuide + NRT: NCI QuitGuide Treatment App and Nicotine Replacement Therapy
|
|---|---|---|
|
Change in Motivation to Quit Smoking
|
-0.005 Score on a scale
Standard Deviation 0.139
|
-0.002 Score on a scale
Standard Deviation 0.118
|
Adverse Events
Smart-T + NRT
NCI QuitGuide + NRT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michael Businelle
Stephenson Cancer Center, University of Oklahoma Health Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place