Trial Outcomes & Findings for Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women (NCT NCT04033237)
NCT ID: NCT04033237
Last Updated: 2025-10-30
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-10-30
Participant Flow
Participant milestones
| Measure |
Very Low Nicotine Content Cigarettes
Very low nicotine content cigarettes: Cigarettes containing 0.4 mg nicotine/g tobacco
|
Usual Brand
Participant's usual brand cigarettes
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women
Baseline characteristics by cohort
| Measure |
Very Low Nicotine Content Cigarettes
n=16 Participants
Very low nicotine content cigarettes: Cigarettes containing 0.4 mg nicotine/g tobacco
|
Usual Brand
n=14 Participants
Participant's usual brand cigarettes
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.31 Years
STANDARD_DEVIATION 4.80 • n=5 Participants
|
27.57 Years
STANDARD_DEVIATION 4.77 • n=7 Participants
|
27.97 Years
STANDARD_DEVIATION 4.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Latino White
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Latino other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Gestational age at screening
|
11.94 Weeks
STANDARD_DEVIATION 4.99 • n=5 Participants
|
13.43 Weeks
STANDARD_DEVIATION 6.26 • n=7 Participants
|
12.63 Weeks
STANDARD_DEVIATION 5.57 • n=5 Participants
|
|
Cigarettes per day pre-pregnancy
|
18.38 Cigarettes per day
STANDARD_DEVIATION 5.91 • n=5 Participants
|
23.93 Cigarettes per day
STANDARD_DEVIATION 14.08 • n=7 Participants
|
20.97 Cigarettes per day
STANDARD_DEVIATION 10.72 • n=5 Participants
|
|
Cigarettes per day
|
19.19 Cigarettes per day
STANDARD_DEVIATION 8.15 • n=5 Participants
|
16.21 Cigarettes per day
STANDARD_DEVIATION 8.05 • n=7 Participants
|
17.80 Cigarettes per day
STANDARD_DEVIATION 8.10 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Very Low Nicotine Content Cigarettes
n=12 Participants
Very low nicotine content cigarettes: Cigarettes containing 0.4 mg nicotine/g tobacco
|
Usual Brand
n=11 Participants
Participant's usual brand cigarettes
|
|---|---|---|
|
Total Cigarettes Per Day
|
16.31 Cigarettes per day
Standard Error 2.63
|
18.36 Cigarettes per day
Standard Error 2.32
|
Adverse Events
Very Low Nicotine Content Cigarettes
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Usual Brand
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Very Low Nicotine Content Cigarettes
n=16 participants at risk
Cigarettes containing 0.4 mg nicotine/g tobacco
|
Usual Brand
n=14 participants at risk
Participant's usual brand cigarettes
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Placenta previa
|
0.00%
0/16 • 12-week intervention period
|
7.1%
1/14 • Number of events 1 • 12-week intervention period
|
Other adverse events
| Measure |
Very Low Nicotine Content Cigarettes
n=16 participants at risk
Cigarettes containing 0.4 mg nicotine/g tobacco
|
Usual Brand
n=14 participants at risk
Participant's usual brand cigarettes
|
|---|---|---|
|
Cardiac disorders
Cardiac disorders
|
12.5%
2/16 • Number of events 2 • 12-week intervention period
|
0.00%
0/14 • 12-week intervention period
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
25.0%
4/16 • Number of events 9 • 12-week intervention period
|
14.3%
2/14 • Number of events 2 • 12-week intervention period
|
|
General disorders
General disorder and administration
|
18.8%
3/16 • Number of events 5 • 12-week intervention period
|
0.00%
0/14 • 12-week intervention period
|
|
Infections and infestations
Infections and infestations
|
25.0%
4/16 • Number of events 4 • 12-week intervention period
|
14.3%
2/14 • Number of events 2 • 12-week intervention period
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue
|
6.2%
1/16 • Number of events 1 • 12-week intervention period
|
21.4%
3/14 • Number of events 3 • 12-week intervention period
|
|
Nervous system disorders
Nervous system disorders
|
6.2%
1/16 • Number of events 3 • 12-week intervention period
|
7.1%
1/14 • Number of events 1 • 12-week intervention period
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy, puerperium and perinatal
|
6.2%
1/16 • Number of events 1 • 12-week intervention period
|
21.4%
3/14 • Number of events 4 • 12-week intervention period
|
|
Psychiatric disorders
Psychiatric disorders
|
12.5%
2/16 • Number of events 3 • 12-week intervention period
|
14.3%
2/14 • Number of events 2 • 12-week intervention period
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastina
|
6.2%
1/16 • Number of events 1 • 12-week intervention period
|
7.1%
1/14 • Number of events 1 • 12-week intervention period
|
|
Vascular disorders
Vascular disorders
|
12.5%
2/16 • Number of events 2 • 12-week intervention period
|
14.3%
2/14 • Number of events 2 • 12-week intervention period
|
|
Respiratory, thoracic and mediastinal disorders
Breath carbon monoxide >50ppm
|
12.5%
2/16 • Number of events 2 • 12-week intervention period
|
7.1%
1/14 • Number of events 1 • 12-week intervention period
|
|
Respiratory, thoracic and mediastinal disorders
Breath carbon monoxide >100% baseline level
|
0.00%
0/16 • 12-week intervention period
|
7.1%
1/14 • Number of events 1 • 12-week intervention period
|
|
Respiratory, thoracic and mediastinal disorders
Cigarettes per day >/= 100% baseline level
|
0.00%
0/16 • 12-week intervention period
|
7.1%
1/14 • Number of events 1 • 12-week intervention period
|
|
Psychiatric disorders
Increased Beck Depression Inventory score
|
43.8%
7/16 • Number of events 8 • 12-week intervention period
|
57.1%
8/14 • Number of events 11 • 12-week intervention period
|
|
Psychiatric disorders
Increased Overall Anxiety Severity and Impairment Scale score
|
25.0%
4/16 • Number of events 5 • 12-week intervention period
|
35.7%
5/14 • Number of events 7 • 12-week intervention period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place