Trial Outcomes & Findings for Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy (NCT NCT00888979)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Baseline to 4 weeks

Results posted on

2017-01-09

Participant milestones
Measure	Nicotrol Inhaler With Behavioral Counseling Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
Overall Study STARTED	10
Overall Study Received the Inhaler/Counseling	8
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	4

Withdrawal data not reported

Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy

Baseline characteristics by cohort
Measure	Nicotrol Inhaler With Behavioral Counseling n=8 Participants Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	26 years n=99 Participants
Gender Female	8 Participants n=99 Participants
Gender Male	0 Participants n=99 Participants
Region of Enrollment United States	8 participants n=99 Participants

Timeframe: Baseline to 4 weeks

Outcome measures
Measure	Nicotrol Inhaler With Behavioral Counseling n=6 Participants Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
Number of Days of Inhaler Use	26.4 days Standard Deviation 3

Timeframe: Baseline to 4 weeks

Outcome measures
Measure	Nicotrol Inhaler With Behavioral Counseling n=6 Participants Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
Cartridge Use	2 cartridges per day Standard Deviation 1.5

Timeframe: Baseline to 4 weeks

Outcome measures
Measure	Nicotrol Inhaler With Behavioral Counseling n=6 Participants Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks.	-5.7 reduction in number of CPD Standard Deviation 2.3

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events
Measure	Nicotrol Inhaler With Behavioral Counseling n=8 participants at risk Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
Pregnancy, puerperium and perinatal conditions preterm premature rupture of membranes	12.5% 1/8 • Number of events 1 • Baseline to delivery, up to 27 weeks)

Other adverse events
Measure	Nicotrol Inhaler With Behavioral Counseling n=8 participants at risk Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
Gastrointestinal disorders Nausea	25.0% 2/8 • Number of events 2 • Baseline to delivery, up to 27 weeks)
Nervous system disorders Headache	25.0% 2/8 • Number of events 3 • Baseline to delivery, up to 27 weeks)
General disorders Lightheadedness	12.5% 1/8 • Number of events 1 • Baseline to delivery, up to 27 weeks)
Gastrointestinal disorders heartburn	12.5% 1/8 • Number of events 1 • Baseline to delivery, up to 27 weeks)

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