Randomized Trial of Nicotine Inhaler for Pregnant Smokers

Area of Science:

• Obstetrics and Gynecology
• Public Health
• Addiction Medicine

Background:

• Smoking during pregnancy is a significant public health concern requiring effective interventions.
• Standard nicotine replacement treatments (NRTs) like patches and gum have not demonstrated efficacy for smoking cessation in pregnancy.
• The nicotine inhaler may offer an advantage by mimicking the sensory aspects of smoking.

Purpose of the Study:

• To evaluate the efficacy and safety of the nicotine inhaler for smoking cessation among pregnant women.
• To determine if the nicotine inhaler increases quit rates, reduces smoking, improves birth weight and gestational age, and decreases preterm birth or low birth weight infants compared to placebo.

Main Methods:

• A randomized, double-blind, placebo-controlled trial involving pregnant smokers (≥5 cigarettes/day).
• Participants received behavioral counseling and a 6-week treatment with either nicotine or placebo inhaler, followed by a 6-week taper.
• Outcomes assessed included biochemically-validated cessation rates, smoking reduction, birth weight, gestational age, and incidence of preterm birth and low birth weight infants.

Main Results:

• Smoking cessation rates at 32-34 weeks gestation were similar between the nicotine (10%) and placebo (18%) groups.
• While cigarettes per day decreased in both groups, the nicotine inhaler showed a greater reduction initially but not at term.
• The incidence of preterm delivery (4% vs. 15%) and low birth weight infants (6% vs. 15%) was significantly lower in the nicotine group compared to placebo.

Conclusions:

• The nicotine inhaler did not significantly increase smoking cessation rates during pregnancy compared to placebo.
• However, the study observed a notable reduction in the incidence of preterm delivery among women using the nicotine inhaler.
• These findings suggest a potential benefit of the nicotine inhaler in improving certain adverse birth outcomes, independent of cessation rates.