N/A
N=10
Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy
Tobacco Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00888979 ↗Enrolled (actual)
10
Serious AEs
12.5%
Results posted
Jan 2017
Primary outcome: Primary: Number of Days of Inhaler Use — 26.4 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nicotrol Inhaler (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Hartford Hospital
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Days of Inhaler Use |
26.4 | — |
| SECONDARY Cartridge Use |
2 | — |
| SECONDARY Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks. |
-5.7 | — |
Summary
We plan to examine the feasibility, acceptability, preliminary quit rates, overall nicotine exposure and adverse effects of the nicotine inhaler for smoking cessation in pregnancy.
Eligibility Criteria
Inclusion Criteria
- 13-26 weeks pregnant
- Smoking at least 5 cigarettes per day the preceding 7 days
- Motivated to quit smoking (at least 7 on a 10 pt. scale)
- Able to speak English
- Intend to carry pregnancy to term
- Stable residence
Exclusion Criteria
- Current drug or alcohol abuse or dependence (other than methadone maintenance
- Twins or multiple gestation
- Unstable psychiatric disorder
- Unstable medical problems
- Known congenital abnormality
- High risk pregnancy
Data sourced from ClinicalTrials.gov (NCT00888979). 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.