ClinicalTrials.gg
Sign In
CompletedNCT01656733Updated Sep 30, 2019Results posted

Nicotine Replacement for Smoking Cessation During Pregnancy

A Phase 4 interventional study of Nicotrol Inhaler and Placebo Inhaler in Nicotine Dependence and Smoking Cessation, sponsored by UConn Health. Completed at 2 sites in United States. Open to female participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-30.

Sponsored by UConn Health · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
16 Years and older
Sex
Female
01

Study 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).

Read the 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

02

Conditions studied

  • Nicotine Dependence
  • Smoking Cessation

Keywords

  • Smoking Cessation
  • Pregnancy
  • Nicotrol Inhaler
  • Placebo Inhaler
  • Nicotine Inhaler
03

In context

Tobacco Use Disorder

988 studies on the registry are indexed under Tobacco Use Disorder; 125 are open to participants now.

This study's enrollment of 154 is above the median of 90 across 863 interventional studies indexed under Tobacco Use Disorder.

Browse Tobacco Use Disorder studies →

Lead sponsor

UConn Health is the lead sponsor of 187 studies on the registry; 18 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.

Browse UConn Health studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
154 participants (actual)

Study arms

  • Experimental
    Nicotrol Inhaler

    Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.

    Drug: Nicotrol Inhaler

  • Placebo comparator
    Placebo Inhaler

    Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper

    Drug: Placebo Inhaler

Interventions

  • DrugNicotrol Inhaler

    Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper

    Also known as: Nicotine Inhaler

  • DrugPlacebo Inhaler

    Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper

06

What researchers measure

Primary outcomes

  1. Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days

    Number of participants who self report an average of zero cigarettes smoked per day in preceding 7 days

    Time frame: 32-34 weeks gestation (Visit 6)

Secondary outcomes

  1. Exhaled Carbon Monoxide

    As measured by parts per million (ppm) on CO breathalyzer

    Time frame: 32-34 weeks gestation

  2. Birth Weight

    Birth weight in grams

    Time frame: At delivery

  3. Gestational Age

    Measure of age of pregnancy at delivery

    Time frame: At delivery

07

Results

Posted Sep 30, 2019

Participant flow

Participants were recruited beginning August 20, 2012. Enrollment sites included Hartford Hospital (Hartford, CT) and Baystate Medical Center (Springfield, MA).

Participant flow — Overall Study
MilestonePlacebo InhalerNicotrol Inhaler
Started6770
Visit 1 (1 week after quit date)4542
Visit 2 (2 weeks after quit date)3244
Visit 3 (3 weeks after quit date)3334
Visit 4 (4 weeks after quit date)3230
Visit 5 (6 weeks after quit date)3736
Visit 6 ( 32-36 weeks gestation)3947
Participants with perinatal outcomes6766
Visit 7 (1 month postpartum) phone call4750
Visit 8 (6 months postpartum)3028
Completed6766
Not completed04
Withdrew: No permission to collect birth outcomes01
Withdrew: Delivery at another hospital02
Withdrew: Spontaneous abortion01

Outcome measures

PrimaryNumber of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days

Number of participants who self report an average of zero cigarettes smoked per day in preceding 7 days

Time frame:
32-34 weeks gestation (Visit 6)
Reported as:
Count of participants · Participants
Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days
ParticipantsPlacebo InhalerNicotrol Inhaler
Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days127
SecondaryExhaled Carbon Monoxide

As measured by parts per million (ppm) on CO breathalyzer

Time frame:
32-34 weeks gestation
Reported as:
Mean · parts per million
Exhaled Carbon Monoxide
parts per millionPlacebo InhalerNicotrol Inhaler
Exhaled Carbon Monoxide5.50 ± 5.426.7 ± 7.4
SecondaryBirth Weight

Birth weight in grams

Time frame:
At delivery
Reported as:
Mean · Grams
Birth Weight
GramsPlacebo InhalerNicotrol Inhaler
Birth Weight3036.78 ± 583.83141.12 ± 561.94
SecondaryGestational Age

Measure of age of pregnancy at delivery

Time frame:
At delivery
Reported as:
Mean · weeks
Gestational Age
weeksPlacebo InhalerNicotrol Inhaler
Gestational Age38.61 ± 2.5339.11 ± 2.42

Adverse events

Collected over Adverse event data was collected from baseline visit up to delivery of infant.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo Inhaler0/67 (0%)40/67 (59.7%)0/67 (0%)
Nicotrol Inhaler0/70 (0%)28/70 (40%)12/70 (17.1%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventPlacebo InhalerNicotrol Inhaler
Neonatal Abstinence SyndromePregnancy, puerperium and perinatal conditions11/6713/70
Low Birth Weigh (<2500 grams)Pregnancy, puerperium and perinatal conditions10/674/70
Preterm deliveryPregnancy, puerperium and perinatal conditions10/673/70
Infant Respiratory DistressRespiratory, thoracic and mediastinal disorders5/672/70
Maternal Hospitalizationfor Medical ConditionPregnancy, puerperium and perinatal conditions1/673/70
Fetal Cardiac AnomalyCardiac disorders1/670/70
Right Club FootCongenital, familial and genetic disorders1/670/70
Infant Low Blood SugarEndocrine disorders1/671/70
Spontaneous AbortionPregnancy, puerperium and perinatal conditions0/671/70
Infant BradycardiaCardiac disorders0/671/70
Most frequent other events
Most frequent other events
EventPlacebo InhalerNicotrol Inhaler
Throat irritationRespiratory, thoracic and mediastinal disorders0/678/70
CoughRespiratory, thoracic and mediastinal disorders0/671/70
NauseaGastrointestinal disorders0/671/70
Bad tasteGeneral disorders0/671/70
Increased mucus in throatGeneral disorders0/671/70

Baseline characteristics

Age, Continuous
Age, Continuous(years)Placebo InhalerNicotrol InhalerTotal
Mean28.24 ± 6.3026.97 ± 5.4527.59 ± 5.90
Sex: Female, Male
Sex: Female, Male(Participants)Placebo InhalerNicotrol InhalerTotal
Female6770137
Male000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Placebo InhalerNicotrol InhalerTotal
Hispanic or Latino332861
Non-Hispanic, White252651
Non-Hispanic, Black81422
Other011
Unknown112
Highest level of education completed
Highest level of education completed(participants)Placebo InhalerNicotrol InhalerTotal
Grade School Completed201838
High School Completed313667
College or post college completed161632
Number of Cigs/day
Number of Cigs/day(cigarettes per day)Placebo InhalerNicotrol InhalerTotal
Mean8.04 ± 4.598.66 ± 4.718.36 ± 4.64
Number of cigarettes per day last two weeks
Number of cigarettes per day last two weeks(cigarettes per day)Placebo InhalerNicotrol InhalerTotal
Mean5.03 ± 4.693.48 ± 3.294.14 ± 3.99
08

Study locations

2 sites
  • Women's Ambulatory Health Services at Hartford Hospital
    Hartford, Connecticut 06106, United States
  • Wesson Women's Clinic at Baystate Medical Center
    Springfield, Massachusetts 01199, United States
09

References and documents

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. PubMed 31380506 ↗

Study documents

  • Protocol and statistical analysis plan · Jan 18, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01656733
Lead sponsor
UConn Health
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Cheryl Oncken (Professor of Medicine, UConn Health) — Principal investigator
First posted
Aug 3, 2012
Start date
Aug 2012
Primary completion
Sep 30, 2017
Completion
Oct 25, 2017
Results posted
Sep 30, 2019
Last update
Sep 30, 2019

Study contacts

Cheryl Oncken, M.D., M.P.H.
principal investigator · UConn Health

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Nicotine Inhaler

Other studies in this condition

Tobacco Use Disorder →

Other studies from this sponsor

UConn Health →

Start the discussion