Nicotine Replacement for Smoking Cessation During Pregnancy

Phase 4 Completed 154 enrolled UConn Health Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab

RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start: 2012-08
Primary completion: 2017-09-30
Completion: 2017-10-25

Outcome

Missed primary endpoint

paper at 32-34 weeks gestation: 10% (7/70) vs. 18% (12/67), respectively, p=0.220 PMID 31380506 ↗

paper Although the nicotine inhaler group did not have a higher quit rate during pregnancy than the placebo group PMID 31380506 ↗

Publications

Oncken C, Dornelas EA, Kuo CL, Sankey HZ, Kranzler HR, Mead EL, Thurlow MSD. Randomized Trial of Nicotine Inhaler for Pregnant Smokers. Am J Obstet Gynecol MFM. 2019 Mar;1(1):10-18. doi: 10.1016/j.ajogmf.2019.03.006. Epub 2019 Mar 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nicotine	Unknown	—	Inhaled