Clinical trial NCT01656733: Nicotine Replacement for Smoking Cessation During Pregnancy
Official title: Nicotine Replacement for Smoking Cessation During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nicotine Dependence
Smoking Cessation
Keywords: Smoking Cessation
Pregnancy
Nicotrol Inhaler
Placebo Inhaler
Nicotine Inhaler
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2012-08-03
Enrollment: 154
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: This project will examine the safety and efficacy of the nicotine inhaler as an aid to smoking cessation during pregnancy. The specific aims are: (1) To examine the efficacy of the nicotine inhaler compared to a matching placebo for smoking cessation during pregnancy; (2) To compare the nicotine inhaler with placebo on overall nicotine exposure (i.e., serum cotinine concentrations), and on birth outcomes (i.e., birth weight and gestational age); (3) To identify factors that determine which women benefit most from the use of the nicotine inhaler for smoking cessation during pregnancy; (4) To explore mechanisms by which the nicotine inhaler increases birth weight and gestational age.

Subjects will be recruited from two prenatal clinics that serve primarily a low-income, minority population.

Pregnant smokers (n=270) who smoke at least 5 cigarettes/ day will receive nurse-delivered behavioral counseling and be randomized to receive a 6-week course of treatment with either a nicotine inhaler or placebo, followed by a 6-week taper. Birth outcomes will be obtained on all participants

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

Primary outcomes:
measure: Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days
timeFrame: 32-34 weeks gestation (Visit 6)
Secondary outcomes:
measure: Exhaled Carbon Monoxide
timeFrame: 32-34 weeks gestation
measure: Birth Weight
timeFrame: At delivery
measure: Gestational Age
timeFrame: At delivery
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Women's Ambulatory Health Services at Hartford Hospital
state: Connecticut
city: Springfield
country: United States
facility: Wesson Women's Clinic at Baystate Medical Center
state: Massachusetts
Study officials:
affiliation: UConn Health
name: Cheryl Oncken, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.