Phase 4
N=137
Nicotine Replacement for Smoking Cessation During Pregnancy
Nicotine Dependence · Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT01656733 ↗Enrolled (actual)
137
Serious AEs
49.6%
Results posted
Sep 2019
Primary outcome: Primary: Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days — 12; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nicotrol Inhaler (Drug); Placebo Inhaler (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- Female
- Sponsor
- UConn Health
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days |
12; 7 | — |
| SECONDARY Exhaled Carbon Monoxide |
5.50; 6.7 | — |
| SECONDARY Birth Weight |
3036.78; 3141.12 | — |
| SECONDARY Gestational Age |
38.61; 39.11 | — |
Summary
This is a clinical trial to determine if the nicotine inhaler in combination with counseling will help pregnant women quit smoking, and whether it is safe when compared to placebo (an inactive inhaler).
Eligibility Criteria
Inclusion Criteria
- smoking at least 5 cigarettes per day for the preceding 7 days
- previous attempt to quit smoking during pregnancy by self report
- 13-26 weeks gestation
- at least 16 years of age
- able to speak English or Spanish
- intent to carry pregnancy to term
- stable residence
Exclusion Criteria
- current drug or alcohol abuse or dependence (other than methadone maintenance)
- twins or other multiple gestation
- unstable psychiatric disorder
- unstable medical problems (e.g., pre-eclampsia, threatened abortion, hyperemesis gravidarum)
- known congenital abnormality
Data sourced from ClinicalTrials.gov (NCT01656733). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.