NCT01656733

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2012

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2017

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

September 30, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

5.2 years

First QC Date

August 1, 2012

Results QC Date

January 31, 2019

Last Update Submit

September 27, 2019

Conditions

Nicotine DependenceSmoking Cessation

Keywords

Smoking CessationPregnancyNicotrol InhalerPlacebo InhalerNicotine Inhaler

Outcome Measures

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

    32-34 weeks gestation (Visit 6)

Secondary Outcomes (3)

  • Exhaled Carbon Monoxide

    32-34 weeks gestation

  • Birth Weight

    At delivery

  • Gestational Age

    At delivery

Study Arms (2)

Nicotrol Inhaler

EXPERIMENTAL

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

Drug: Nicotrol Inhaler

Placebo Inhaler

PLACEBO COMPARATOR

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

Drug: Placebo Inhaler

Interventions

Nicotrol InhalerDRUG

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

Also known as: Nicotine Inhaler
Nicotrol Inhaler
Placebo InhalerDRUG

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

Placebo Inhaler

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • smoking at least 5 cigarettes per day for the preceding 7 days
  • previous attempt to quit smoking during pregnancy by self report
  • weeks gestation
  • at least 16 years of age
  • able to speak English or Spanish
  • intent to carry pregnancy to term
  • stable residence

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Women's Ambulatory Health Services at Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Wesson Women's Clinic at Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Related Publications (1)

  • 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.

    PMID: 31380506DERIVED

MeSH Terms

Conditions

Tobacco Use DisorderSmoking Cessation

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Cheryl Oncken, MD, MPH
Organization
University of Connecticut School of Medicine
oncken@uchc.edu
860-679-3425

Study Officials

  • Cheryl Oncken, M.D., M.P.H.

    UConn Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

August 1, 2012

First Posted

August 3, 2012

Study Start

August 1, 2012

Primary Completion

September 30, 2017

Study Completion

October 25, 2017

Last Updated

September 30, 2019

Results First Posted

September 30, 2019

Record last verified: 2019-09

Locations

US(2)