Trial Outcomes & Findings for Risk and Benefits of Electronic Cigarettes to Older Smokers at High Risk for Lung Cancer (NCT NCT05144542)
NCT ID: NCT05144542
Last Updated: 2026-08-05
Results Overview
Mean cigarettes per day during the week of baseline combustible cigarette smoking and during the final week of electronic cigarette provision (week 27)
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
135 participants
Primary outcome timeframe
Study Week 1 and Week 27
Results posted on
2026-08-05
Participant Flow
Participants were adults residing in the state of Texas
Participant milestones
| Measure |
Electronic Cigarettes Arm
Assigned to vape electronic cigarettes for up to 26 weeks
|
|---|---|
|
Overall Study
STARTED
|
135
|
|
Overall Study
COMPLETED
|
107
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Electronic Cigarettes Arm
Assigned to vape electronic cigarettes for up to 26 weeks
|
|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
|
Overall Study
Withdrawal by Subject
|
17
|
Baseline Characteristics
Risk and Benefits of Electronic Cigarettes to Older Smokers at High Risk for Lung Cancer
Baseline characteristics by cohort
| Measure |
Electronic Cigarettes Arm
n=135 Participants
Assigned to vape electronic cigarettes for up to 26 weeks
|
|---|---|
|
Age, Continuous
|
56.51 years
STANDARD_DEVIATION 5.46 • n=20 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
124 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
135 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Study Week 1 and Week 27Mean cigarettes per day during the week of baseline combustible cigarette smoking and during the final week of electronic cigarette provision (week 27)
Outcome measures
| Measure |
Electronic Cigarettes Arm
n=135 Participants
Assigned to vape electronic cigarettes for up to 26 weeks
|
|---|---|
|
Combustible Cigarettes Per Day
Baseline Combustible Cigarette Smoking (study week 1)
|
15.36 cigarettes per day
Standard Deviation 8.93
|
|
Combustible Cigarettes Per Day
Electronic Cigarette Provision (study week 27)
|
7.52 cigarettes per day
Standard Deviation 7.54
|
SECONDARY outcome
Timeframe: Study Week 27Mean electronic cigarette sessions per day during the week of baseline combustible cigarette smoking and during the final week of electronic cigarette provision (week 27)
Outcome measures
| Measure |
Electronic Cigarettes Arm
n=135 Participants
Assigned to vape electronic cigarettes for up to 26 weeks
|
|---|---|
|
Electronic Cigarette Sessions Per Day
|
11.13 Electronic Cigarette Sessions per Day
Standard Deviation 11.99
|
SECONDARY outcome
Timeframe: Study Week 1 and Week 27Geometric means of the natural log of urine anabasine levels collected at study week 1 (end of combustible cigarette smoking baseline) and week 27 (end of electronic cigarette provision).
Outcome measures
| Measure |
Electronic Cigarettes Arm
n=135 Participants
Assigned to vape electronic cigarettes for up to 26 weeks
|
|---|---|
|
Anabasine
Baseline Combustible Cigarette Smoking (study week 1)
|
40.9 ln(ng/mL)
Interval 33.13 to 50.48
|
|
Anabasine
Electronic Cigarette Provision (study week 27)
|
37.56 ln(ng/mL)
Interval 27.5 to 51.31
|
SECONDARY outcome
Timeframe: Study Week 1 and Week 27The Fagerström Test for Cigarette Dependence (FTCD) is a measure of cigarette dependence. Scores range from 0 to 10, with higher scores indicating greater dependence.
Outcome measures
| Measure |
Electronic Cigarettes Arm
n=135 Participants
Assigned to vape electronic cigarettes for up to 26 weeks
|
|---|---|
|
Fagerström Test for Cigarette Dependence
Baseline Combustible Cigarette Smoking (study week 1)
|
4.39 score on a scale
Standard Deviation 3.99
|
|
Fagerström Test for Cigarette Dependence
Electronic Cigarette Provision (study week 27)
|
2.94 score on a scale
Standard Deviation 2.48
|
Adverse Events
Electronic Cigarettes Arm
Serious events: 7 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Electronic Cigarettes Arm
n=135 participants at risk
Assigned to vape electronic cigarettes for up to 26 weeks
|
|---|---|
|
Psychiatric disorders
Anxiety
|
0.74%
1/135 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.74%
1/135 • 26 weeks
|
|
Psychiatric disorders
Depression
|
0.74%
1/135 • 26 weeks
|
|
Injury, poisoning and procedural complications
Fracture
|
0.74%
1/135 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
0.74%
1/135 • 26 weeks
|
|
Nervous system disorders
Stroke
|
1.5%
2/135 • 26 weeks
|
Other adverse events
| Measure |
Electronic Cigarettes Arm
n=135 participants at risk
Assigned to vape electronic cigarettes for up to 26 weeks
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.0%
4/135 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.7%
5/135 • 26 weeks
|
|
General disorders
Chest Pain - Non Cardiac
|
8.9%
12/135 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
3.0%
4/135 • 26 weeks
|
|
Psychiatric disorders
Depression
|
2.2%
3/135 • 26 weeks
|
|
General disorders
Edema
|
1.5%
2/135 • 26 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
2/135 • 26 weeks
|
|
General disorders
Fatigue
|
27.4%
37/135 • 26 weeks
|
|
General disorders
Fever
|
1.5%
2/135 • 26 weeks
|
|
General disorders
Flu Like Symptoms
|
3.7%
5/135 • 26 weeks
|
|
Injury, poisoning and procedural complications
Fracture
|
2.2%
3/135 • 26 weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
1.5%
2/135 • 26 weeks
|
|
Vascular disorders
Hypertension
|
4.4%
6/135 • 26 weeks
|
|
Infections and infestations
Infection
|
2.2%
3/135 • 26 weeks
|
|
Gastrointestinal disorders
Nausea
|
1.5%
2/135 • 26 weeks
|
|
Infections and infestations
Pneumonia
|
2.2%
3/135 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
14.8%
20/135 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Shortness Of Breath
|
20.7%
28/135 • 26 weeks
|
|
Infections and infestations
Sinusitis
|
2.2%
3/135 • 26 weeks
|
|
Surgical and medical procedures
Surgical And Medical Procedures - Other
|
3.0%
4/135 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.5%
2/135 • 26 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place