Trial Outcomes & Findings for Low Nicotine Content Cigarettes in Vulnerable Populations: Women of Reproductive Age (NCT NCT04092387)
NCT ID: NCT04092387
Last Updated: 2025-03-18
Results Overview
Cigarettes per day will be assessed for use of cigarettes with different nicotine content.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
326 participants
Primary outcome timeframe
16 weeks
Results posted on
2025-03-18
Participant Flow
Participant milestones
| Measure |
RC 1 Only
Research cigarettes #1
Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes
|
RC 2 Only
Research Cigarettes #2
Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes
|
RC 2 + EC 1
Research Cigarettes #2 plus E-cigarettes #1
Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes
E-Cigarettes: Comparing effects of combining RC2 with EC 1 versus EC2
|
RC 2 + EC 2
Research Cigarettes #2 plus E-cigarettes #2
Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes
E-Cigarettes: Comparing effects of combining RC2 with EC 1 versus EC2
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
83
|
85
|
74
|
84
|
|
Overall Study
COMPLETED
|
67
|
66
|
57
|
70
|
|
Overall Study
NOT COMPLETED
|
16
|
19
|
17
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low Nicotine Content Cigarettes in Vulnerable Populations: Women of Reproductive Age
Baseline characteristics by cohort
| Measure |
RC 1 Only
n=83 Participants
Research cigarettes #1
Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes
|
RC 2 Only
n=85 Participants
Research Cigarettes #2
Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes
|
RC 2 + EC 1
n=74 Participants
Research Cigarettes #2 plus E-cigarettes #1
Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes
E-Cigarettes: Comparing effects of combining RC2 with EC 1 versus EC2
|
RC 2 + EC 2
n=84 Participants
Research Cigarettes #2 plus E-cigarettes #2
Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes
E-Cigarettes: Comparing effects of combining RC2 with EC 1 versus EC2
|
Total
n=326 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.77 years
STANDARD_DEVIATION 10.98 • n=99 Participants
|
39.85 years
STANDARD_DEVIATION 9.28 • n=107 Participants
|
41.51 years
STANDARD_DEVIATION 12.39 • n=206 Participants
|
39.38 years
STANDARD_DEVIATION 10.59 • n=7 Participants
|
40.09 years
STANDARD_DEVIATION 10.79 • n=31 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
59 Participants
n=7 Participants
|
243 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
83 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black, non-Latino
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
33 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Latino
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White, non-Latino
|
66 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
68 Participants
n=7 Participants
|
262 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Non-Latino other or multiracial
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
83 participants
n=99 Participants
|
85 participants
n=107 Participants
|
74 participants
n=206 Participants
|
84 participants
n=7 Participants
|
326 participants
n=31 Participants
|
|
Population
Females with lower educational level
|
20 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
80 Participants
n=31 Participants
|
|
Population
OUD
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
74 Participants
n=31 Participants
|
|
Population
Affective disorders
|
44 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
172 Participants
n=31 Participants
|
|
Educational level
<High school
|
9 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
|
Educational level
High school graduate, equivalency, or some college
|
51 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
201 Participants
n=31 Participants
|
|
Educational level
Associate's degree
|
8 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
43 Participants
n=31 Participants
|
|
Educational level
≥College graduate
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
52 Participants
n=31 Participants
|
|
Marital status
Married
|
8 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
51 Participants
n=31 Participants
|
|
Marital status
Never married
|
49 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
180 Participants
n=31 Participants
|
|
Marital status
Divorced, separated, or widowed
|
26 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
95 Participants
n=31 Participants
|
|
Primarily smokes mentholated cigarettes
|
32 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
131 Participants
n=31 Participants
|
|
Cigarettes smoked per day
|
16.42 cigarettes per day
STANDARD_DEVIATION 8.02 • n=99 Participants
|
18.44 cigarettes per day
STANDARD_DEVIATION 9.47 • n=107 Participants
|
17.86 cigarettes per day
STANDARD_DEVIATION 9.11 • n=206 Participants
|
16.90 cigarettes per day
STANDARD_DEVIATION 8.85 • n=7 Participants
|
17.40 cigarettes per day
STANDARD_DEVIATION 8.87 • n=31 Participants
|
|
Urine cotinine level
|
4499.25 ng/mL
STANDARD_DEVIATION 3120.20 • n=99 Participants
|
5235.67 ng/mL
STANDARD_DEVIATION 3251.28 • n=107 Participants
|
5156.57 ng/mL
STANDARD_DEVIATION 4150.44 • n=206 Participants
|
5293.33 ng/mL
STANDARD_DEVIATION 3799.45 • n=7 Participants
|
5043.55 ng/mL
STANDARD_DEVIATION 3680.12 • n=31 Participants
|
|
Breath CO level
|
20.90 ppm
STANDARD_DEVIATION 14.02 • n=99 Participants
|
19.30 ppm
STANDARD_DEVIATION 12.39 • n=107 Participants
|
21.03 ppm
STANDARD_DEVIATION 13.38 • n=206 Participants
|
20.66 ppm
STANDARD_DEVIATION 13.44 • n=7 Participants
|
20.46 ppm
STANDARD_DEVIATION 13.28 • n=31 Participants
|
|
Age started smoking regularly
|
16.61 years
STANDARD_DEVIATION 3.97 • n=99 Participants
|
15.92 years
STANDARD_DEVIATION 3.91 • n=107 Participants
|
16.24 years
STANDARD_DEVIATION 3.84 • n=206 Participants
|
16.79 years
STANDARD_DEVIATION 5.15 • n=7 Participants
|
16.39 years
STANDARD_DEVIATION 4.26 • n=31 Participants
|
|
FTND score
|
5.12 scores on a scale
STANDARD_DEVIATION 2.24 • n=99 Participants
|
5.31 scores on a scale
STANDARD_DEVIATION 2.20 • n=107 Participants
|
5.26 scores on a scale
STANDARD_DEVIATION 2.31 • n=206 Participants
|
4.70 scores on a scale
STANDARD_DEVIATION 2.07 • n=7 Participants
|
5.09 scores on a scale
STANDARD_DEVIATION 2.21 • n=31 Participants
|
|
Used other tobacco products, past 30 days
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
|
Used e-cigarettes, past 30 days
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
42 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Participants who completed week 16 of study
Cigarettes per day will be assessed for use of cigarettes with different nicotine content.
Outcome measures
| Measure |
RC 1 Only
n=67 Participants
Research cigarettes #1
Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes
|
RC 2 Only
n=66 Participants
Research Cigarettes #2
Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes
|
RC 2 + EC 1
n=57 Participants
Research Cigarettes #2 plus E-cigarettes #1
Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes
E-Cigarettes: Comparing effects of combining RC2 with EC 1 versus EC2
|
RC 2 + EC 2
n=70 Participants
Research Cigarettes #2 plus E-cigarettes #2
Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes
E-Cigarettes: Comparing effects of combining RC2 with EC 1 versus EC2
|
|---|---|---|---|---|
|
Number of Cigarettes Smoked Per Day
|
22.54 cigarettes per day
Standard Error 1.59
|
14.32 cigarettes per day
Standard Error 1.32
|
11.76 cigarettes per day
Standard Error 1.18
|
7.63 cigarettes per day
Standard Error 0.90
|
Adverse Events
RC 1 Only
Serious events: 9 serious events
Other events: 71 other events
Deaths: 0 deaths
RC 2 Only
Serious events: 4 serious events
Other events: 74 other events
Deaths: 0 deaths
RC 2 + EC 1
Serious events: 4 serious events
Other events: 62 other events
Deaths: 1 deaths
RC 2 + EC 2
Serious events: 2 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RC 1 Only
n=83 participants at risk
Research cigarettes #1
Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes
|
RC 2 Only
n=85 participants at risk
Research Cigarettes #2
Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes
|
RC 2 + EC 1
n=74 participants at risk
Research Cigarettes #2 plus E-cigarettes #1
Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes
E-Cigarettes: Comparing effects of combining RC2 with EC 1 versus EC2
|
RC 2 + EC 2
n=84 participants at risk
Research Cigarettes #2 plus E-cigarettes #2
Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes
E-Cigarettes: Comparing effects of combining RC2 with EC 1 versus EC2
|
|---|---|---|---|---|
|
Psychiatric disorders
Psychiatric disorders - Other
|
3.6%
3/83 • Number of events 3 • 16 weeks
|
0.00%
0/85 • 16 weeks
|
0.00%
0/74 • 16 weeks
|
0.00%
0/84 • 16 weeks
|
|
Gastrointestinal disorders
Esophageal perforation
|
1.2%
1/83 • Number of events 1 • 16 weeks
|
0.00%
0/85 • 16 weeks
|
0.00%
0/74 • 16 weeks
|
0.00%
0/84 • 16 weeks
|
|
General disorders
Irritability
|
1.2%
1/83 • Number of events 1 • 16 weeks
|
0.00%
0/85 • 16 weeks
|
0.00%
0/74 • 16 weeks
|
0.00%
0/84 • 16 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
1.2%
1/83 • Number of events 1 • 16 weeks
|
0.00%
0/85 • 16 weeks
|
0.00%
0/74 • 16 weeks
|
0.00%
0/84 • 16 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy, puerperium and perinatal conditions
|
1.2%
1/83 • Number of events 1 • 16 weeks
|
0.00%
0/85 • 16 weeks
|
0.00%
0/74 • 16 weeks
|
0.00%
0/84 • 16 weeks
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
1.2%
1/83 • Number of events 1 • 16 weeks
|
1.2%
1/85 • Number of events 1 • 16 weeks
|
0.00%
0/74 • 16 weeks
|
0.00%
0/84 • 16 weeks
|
|
Vascular disorders
Hypertension
|
1.2%
1/83 • Number of events 1 • 16 weeks
|
0.00%
0/85 • 16 weeks
|
1.4%
1/74 • Number of events 1 • 16 weeks
|
0.00%
0/84 • 16 weeks
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/83 • 16 weeks
|
1.2%
1/85 • Number of events 1 • 16 weeks
|
0.00%
0/74 • 16 weeks
|
0.00%
0/84 • 16 weeks
|
|
General disorders
Fever
|
0.00%
0/83 • 16 weeks
|
1.2%
1/85 • Number of events 1 • 16 weeks
|
0.00%
0/74 • 16 weeks
|
0.00%
0/84 • 16 weeks
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/83 • 16 weeks
|
1.2%
1/85 • Number of events 1 • 16 weeks
|
0.00%
0/74 • 16 weeks
|
0.00%
0/84 • 16 weeks
|
|
General disorders
Death NOS
|
0.00%
0/83 • 16 weeks
|
0.00%
0/85 • 16 weeks
|
1.4%
1/74 • Number of events 1 • 16 weeks
|
0.00%
0/84 • 16 weeks
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
0.00%
0/83 • 16 weeks
|
0.00%
0/85 • 16 weeks
|
1.4%
1/74 • Number of events 1 • 16 weeks
|
0.00%
0/84 • 16 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/83 • 16 weeks
|
0.00%
0/85 • 16 weeks
|
1.4%
1/74 • Number of events 1 • 16 weeks
|
0.00%
0/84 • 16 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/83 • 16 weeks
|
0.00%
0/85 • 16 weeks
|
0.00%
0/74 • 16 weeks
|
1.2%
1/84 • Number of events 1 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/83 • 16 weeks
|
0.00%
0/85 • 16 weeks
|
0.00%
0/74 • 16 weeks
|
1.2%
1/84 • Number of events 1 • 16 weeks
|
Other adverse events
| Measure |
RC 1 Only
n=83 participants at risk
Research cigarettes #1
Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes
|
RC 2 Only
n=85 participants at risk
Research Cigarettes #2
Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes
|
RC 2 + EC 1
n=74 participants at risk
Research Cigarettes #2 plus E-cigarettes #1
Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes
E-Cigarettes: Comparing effects of combining RC2 with EC 1 versus EC2
|
RC 2 + EC 2
n=84 participants at risk
Research Cigarettes #2 plus E-cigarettes #2
Varying the nicotine content of cigarettes: 1) Altering the nicotine content of the tobacco research cigarettes
E-Cigarettes: Comparing effects of combining RC2 with EC 1 versus EC2
|
|---|---|---|---|---|
|
Psychiatric disorders
OASIS Score Increase
|
38.6%
32/83 • Number of events 51 • 16 weeks
|
36.5%
31/85 • Number of events 43 • 16 weeks
|
41.9%
31/74 • Number of events 42 • 16 weeks
|
36.9%
31/84 • Number of events 40 • 16 weeks
|
|
Psychiatric disorders
BDI Category Increase
|
34.9%
29/83 • Number of events 51 • 16 weeks
|
34.1%
29/85 • Number of events 40 • 16 weeks
|
35.1%
26/74 • Number of events 34 • 16 weeks
|
29.8%
25/84 • Number of events 41 • 16 weeks
|
|
Psychiatric disorders
Psychiatric disorders
|
32.5%
27/83 • Number of events 53 • 16 weeks
|
32.9%
28/85 • Number of events 43 • 16 weeks
|
25.7%
19/74 • Number of events 27 • 16 weeks
|
28.6%
24/84 • Number of events 37 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
27.7%
23/83 • Number of events 38 • 16 weeks
|
31.8%
27/85 • Number of events 44 • 16 weeks
|
24.3%
18/74 • Number of events 40 • 16 weeks
|
21.4%
18/84 • Number of events 35 • 16 weeks
|
|
General disorders
General disorders and administration
|
21.7%
18/83 • Number of events 25 • 16 weeks
|
28.2%
24/85 • Number of events 27 • 16 weeks
|
21.6%
16/74 • Number of events 20 • 16 weeks
|
26.2%
22/84 • Number of events 27 • 16 weeks
|
|
Infections and infestations
Infections and infestations
|
19.3%
16/83 • Number of events 17 • 16 weeks
|
27.1%
23/85 • Number of events 24 • 16 weeks
|
10.8%
8/74 • Number of events 11 • 16 weeks
|
11.9%
10/84 • Number of events 13 • 16 weeks
|
|
Nervous system disorders
Nervous system disorders
|
8.4%
7/83 • Number of events 8 • 16 weeks
|
21.2%
18/85 • Number of events 23 • 16 weeks
|
20.3%
15/74 • Number of events 19 • 16 weeks
|
11.9%
10/84 • Number of events 11 • 16 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
10.8%
9/83 • Number of events 14 • 16 weeks
|
20.0%
17/85 • Number of events 25 • 16 weeks
|
18.9%
14/74 • Number of events 20 • 16 weeks
|
20.2%
17/84 • Number of events 23 • 16 weeks
|
|
Vascular disorders
Vascular disorders
|
12.0%
10/83 • Number of events 13 • 16 weeks
|
15.3%
13/85 • Number of events 15 • 16 weeks
|
10.8%
8/74 • Number of events 10 • 16 weeks
|
19.0%
16/84 • Number of events 30 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
13.3%
11/83 • Number of events 14 • 16 weeks
|
18.8%
16/85 • Number of events 16 • 16 weeks
|
9.5%
7/74 • Number of events 7 • 16 weeks
|
14.3%
12/84 • Number of events 12 • 16 weeks
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
7.2%
6/83 • Number of events 7 • 16 weeks
|
4.7%
4/85 • Number of events 7 • 16 weeks
|
5.4%
4/74 • Number of events 4 • 16 weeks
|
6.0%
5/84 • Number of events 8 • 16 weeks
|
|
Surgical and medical procedures
Surgical and medical procedures
|
2.4%
2/83 • Number of events 2 • 16 weeks
|
3.5%
3/85 • Number of events 3 • 16 weeks
|
6.8%
5/74 • Number of events 5 • 16 weeks
|
4.8%
4/84 • Number of events 4 • 16 weeks
|
|
Cardiac disorders
Cardiac disorders
|
4.8%
4/83 • Number of events 6 • 16 weeks
|
2.4%
2/85 • Number of events 4 • 16 weeks
|
4.1%
3/74 • Number of events 4 • 16 weeks
|
3.6%
3/84 • Number of events 5 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place