Trial Outcomes & Findings for Nicotine Replacement for Smoking Cessation During Pregnancy (NCT NCT01656733)
NCT ID: NCT01656733
Last Updated: 2019-09-30
Results Overview
Number of participants who self report an average of zero cigarettes smoked per day in preceding 7 days
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
154 participants
Primary outcome timeframe
32-34 weeks gestation (Visit 6)
Results posted on
2019-09-30
Participant Flow
Participants were recruited beginning August 20, 2012. Enrollment sites included Hartford Hospital (Hartford, CT) and Baystate Medical Center (Springfield, MA).
154 participants gave written consent for study participation and 137 were randomized. Therefore, 17 participants were excluded for the following reasons: no show after screen (10), high PHQ9 (2), moved out of area (2), current drug use (1), advanced gestational age (1), and stress too high to continue (1).
Participant milestones
| Measure |
Placebo Inhaler
Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
Nicotrol Inhaler: Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper Placebo Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
|
Nicotrol Inhaler
Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
Nicotrol Inhaler: Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper Placebo Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
70
|
|
Overall Study
Visit 1 (1 Week After Quit Date)
|
45
|
42
|
|
Overall Study
Visit 2 (2 Weeks After Quit Date)
|
32
|
44
|
|
Overall Study
Visit 3 (3 Weeks After Quit Date)
|
33
|
34
|
|
Overall Study
Visit 4 (4 Weeks After Quit Date)
|
32
|
30
|
|
Overall Study
Visit 5 (6 Weeks After Quit Date)
|
37
|
36
|
|
Overall Study
Visit 6 ( 32-36 Weeks Gestation)
|
39
|
47
|
|
Overall Study
Participants With Perinatal Outcomes
|
67
|
66
|
|
Overall Study
Visit 7 (1 Month Postpartum) Phone Call
|
47
|
50
|
|
Overall Study
Visit 8 (6 Months Postpartum)
|
30
|
28
|
|
Overall Study
COMPLETED
|
67
|
66
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
| Measure |
Placebo Inhaler
Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
Nicotrol Inhaler: Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper Placebo Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
|
Nicotrol Inhaler
Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
Nicotrol Inhaler: Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper Placebo Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
|
|---|---|---|
|
Overall Study
No permission to collect birth outcomes
|
0
|
1
|
|
Overall Study
Delivery at another hospital
|
0
|
2
|
|
Overall Study
Spontaneous abortion
|
0
|
1
|
Baseline Characteristics
Nicotine Replacement for Smoking Cessation During Pregnancy
Baseline characteristics by cohort
| Measure |
Placebo Inhaler
n=67 Participants
Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
|
Nicotrol Inhaler
n=70 Participants
Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.24 years
STANDARD_DEVIATION 6.30 • n=99 Participants
|
26.97 years
STANDARD_DEVIATION 5.45 • n=107 Participants
|
27.59 years
STANDARD_DEVIATION 5.90 • n=206 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
137 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
33 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic, White
|
25 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic, Black
|
8 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Highest level of education completed
Grade School Completed
|
20 participants
n=99 Participants
|
18 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Highest level of education completed
High School Completed
|
31 participants
n=99 Participants
|
36 participants
n=107 Participants
|
67 participants
n=206 Participants
|
|
Highest level of education completed
College or post college completed
|
16 participants
n=99 Participants
|
16 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
Number of Cigs/day
|
8.04 cigarettes per day
STANDARD_DEVIATION 4.59 • n=99 Participants
|
8.66 cigarettes per day
STANDARD_DEVIATION 4.71 • n=107 Participants
|
8.36 cigarettes per day
STANDARD_DEVIATION 4.64 • n=206 Participants
|
|
Number of cigarettes per day last two weeks
|
5.03 cigarettes per day
STANDARD_DEVIATION 4.69 • n=99 Participants
|
3.48 cigarettes per day
STANDARD_DEVIATION 3.29 • n=107 Participants
|
4.14 cigarettes per day
STANDARD_DEVIATION 3.99 • n=206 Participants
|
PRIMARY outcome
Timeframe: 32-34 weeks gestation (Visit 6)Number of participants who self report an average of zero cigarettes smoked per day in preceding 7 days
Outcome measures
| Measure |
Placebo Inhaler
n=67 Participants
Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
|
Nicotrol Inhaler
n=70 Participants
Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
|
|---|---|---|
|
Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days
|
12 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 32-34 weeks gestationPopulation: Overall number of participants includes only those that attended the 32-34 gestation week visit
As measured by parts per million (ppm) on CO breathalyzer
Outcome measures
| Measure |
Placebo Inhaler
n=40 Participants
Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
|
Nicotrol Inhaler
n=46 Participants
Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
|
|---|---|---|
|
Exhaled Carbon Monoxide
|
5.50 parts per million
Standard Deviation 5.42
|
6.7 parts per million
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: At deliveryPopulation: Could not obtain birth outcomes on 4 individuals in nicotine group for various reasons.
Birth weight in grams
Outcome measures
| Measure |
Placebo Inhaler
n=67 Participants
Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
|
Nicotrol Inhaler
n=66 Participants
Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
|
|---|---|---|
|
Birth Weight
|
3036.78 Grams
Standard Deviation 583.8
|
3141.12 Grams
Standard Deviation 561.94
|
SECONDARY outcome
Timeframe: At deliveryPopulation: Could not obtain birth outcomes on 4 individuals in nicotine group for various reasons.
Measure of age of pregnancy at delivery
Outcome measures
| Measure |
Placebo Inhaler
n=67 Participants
Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
|
Nicotrol Inhaler
n=66 Participants
Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
|
|---|---|---|
|
Gestational Age
|
38.61 weeks
Standard Deviation 2.53
|
39.11 weeks
Standard Deviation 2.42
|
Adverse Events
Placebo Inhaler
Serious events: 40 serious events
Other events: 0 other events
Deaths: 0 deaths
Nicotrol Inhaler
Serious events: 28 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Inhaler
n=67 participants at risk
Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
Nicotrol Inhaler: Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper Placebo Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
|
Nicotrol Inhaler
n=70 participants at risk
Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
Nicotrol Inhaler: Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper Placebo Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Low Birth Weigh (<2500 grams)
|
14.9%
10/67 • Adverse event data was collected from baseline visit up to delivery of infant.
|
5.7%
4/70 • Adverse event data was collected from baseline visit up to delivery of infant.
|
|
Pregnancy, puerperium and perinatal conditions
Preterm delivery
|
14.9%
10/67 • Adverse event data was collected from baseline visit up to delivery of infant.
|
4.3%
3/70 • Adverse event data was collected from baseline visit up to delivery of infant.
|
|
Pregnancy, puerperium and perinatal conditions
Spontaneous Abortion
|
0.00%
0/67 • Adverse event data was collected from baseline visit up to delivery of infant.
|
1.4%
1/70 • Adverse event data was collected from baseline visit up to delivery of infant.
|
|
Pregnancy, puerperium and perinatal conditions
Perinatal Mortality
|
0.00%
0/67 • Adverse event data was collected from baseline visit up to delivery of infant.
|
0.00%
0/70 • Adverse event data was collected from baseline visit up to delivery of infant.
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal Abstinence Syndrome
|
16.4%
11/67 • Adverse event data was collected from baseline visit up to delivery of infant.
|
18.6%
13/70 • Adverse event data was collected from baseline visit up to delivery of infant.
|
|
Pregnancy, puerperium and perinatal conditions
Maternal Hospitalizationfor Medical Condition
|
1.5%
1/67 • Adverse event data was collected from baseline visit up to delivery of infant.
|
4.3%
3/70 • Adverse event data was collected from baseline visit up to delivery of infant.
|
|
Cardiac disorders
Fetal Cardiac Anomaly
|
1.5%
1/67 • Adverse event data was collected from baseline visit up to delivery of infant.
|
0.00%
0/70 • Adverse event data was collected from baseline visit up to delivery of infant.
|
|
Congenital, familial and genetic disorders
Right Club Foot
|
1.5%
1/67 • Adverse event data was collected from baseline visit up to delivery of infant.
|
0.00%
0/70 • Adverse event data was collected from baseline visit up to delivery of infant.
|
|
Respiratory, thoracic and mediastinal disorders
Infant Respiratory Distress
|
7.5%
5/67 • Adverse event data was collected from baseline visit up to delivery of infant.
|
2.9%
2/70 • Adverse event data was collected from baseline visit up to delivery of infant.
|
|
Endocrine disorders
Infant Low Blood Sugar
|
1.5%
1/67 • Adverse event data was collected from baseline visit up to delivery of infant.
|
1.4%
1/70 • Adverse event data was collected from baseline visit up to delivery of infant.
|
|
Cardiac disorders
Infant Bradycardia
|
0.00%
0/67 • Adverse event data was collected from baseline visit up to delivery of infant.
|
1.4%
1/70 • Adverse event data was collected from baseline visit up to delivery of infant.
|
Other adverse events
| Measure |
Placebo Inhaler
n=67 participants at risk
Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
Nicotrol Inhaler: Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper Placebo Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
|
Nicotrol Inhaler
n=70 participants at risk
Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
Nicotrol Inhaler: Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper Placebo Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/67 • Adverse event data was collected from baseline visit up to delivery of infant.
|
11.4%
8/70 • Adverse event data was collected from baseline visit up to delivery of infant.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/67 • Adverse event data was collected from baseline visit up to delivery of infant.
|
1.4%
1/70 • Adverse event data was collected from baseline visit up to delivery of infant.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/67 • Adverse event data was collected from baseline visit up to delivery of infant.
|
1.4%
1/70 • Adverse event data was collected from baseline visit up to delivery of infant.
|
|
General disorders
Bad taste
|
0.00%
0/67 • Adverse event data was collected from baseline visit up to delivery of infant.
|
1.4%
1/70 • Adverse event data was collected from baseline visit up to delivery of infant.
|
|
General disorders
Increased mucus in throat
|
0.00%
0/67 • Adverse event data was collected from baseline visit up to delivery of infant.
|
1.4%
1/70 • Adverse event data was collected from baseline visit up to delivery of infant.
|
Additional Information
Cheryl Oncken, MD, MPH
University of Connecticut School of Medicine
Phone: 860-679-3425
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place