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Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nicotrol Inhaler
Sponsored by
Hartford Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring Smoking Cessation during Pregnancy, Nicotrol Inhaler

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 13-26 weeks pregnant
  • Smoking at least 5 cigarettes per day the preceding 7 days
  • Motivated to quit smoking (at least 7 on a 10 pt. scale)
  • Able to speak English
  • Intend to carry pregnancy to term
  • Stable residence

Exclusion Criteria:

  • Current drug or alcohol abuse or dependence (other than methadone maintenance
  • Twins or multiple gestation
  • Unstable psychiatric disorder
  • Unstable medical problems
  • Known congenital abnormality
  • High risk pregnancy

Sites / Locations

  • Hartford Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nicotrol with Behavioral Counseling

Arm Description

Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern

Outcomes

Primary Outcome Measures

Number of Days of Inhaler Use

Secondary Outcome Measures

Cartridge Use
Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks.

Full Information

First Posted
April 24, 2009
Last Updated
November 10, 2016
Sponsor
Hartford Hospital
Collaborators
UConn Health
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1. Study Identification

Unique Protocol Identification Number
NCT00888979
Brief Title
Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy
Official Title
Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hartford Hospital
Collaborators
UConn Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
We plan to examine the feasibility, acceptability, preliminary quit rates, overall nicotine exposure and adverse effects of the nicotine inhaler for smoking cessation in pregnancy.
Detailed Description
Subjects in this pilot study are healthy pregnant women who wish to quit smoking. They will set a quit date and use the nicotine inhaler for 4 weeks. They will receive behavioral counseling in addition to the inhaler for 4 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
Smoking Cessation during Pregnancy, Nicotrol Inhaler

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nicotrol with Behavioral Counseling
Arm Type
Experimental
Arm Description
Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
Intervention Type
Drug
Intervention Name(s)
Nicotrol Inhaler
Intervention Description
10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
Primary Outcome Measure Information:
Title
Number of Days of Inhaler Use
Time Frame
Baseline to 4 weeks
Secondary Outcome Measure Information:
Title
Cartridge Use
Time Frame
Baseline to 4 weeks
Title
Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks.
Time Frame
Baseline to 4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 13-26 weeks pregnant Smoking at least 5 cigarettes per day the preceding 7 days Motivated to quit smoking (at least 7 on a 10 pt. scale) Able to speak English Intend to carry pregnancy to term Stable residence Exclusion Criteria: Current drug or alcohol abuse or dependence (other than methadone maintenance Twins or multiple gestation Unstable psychiatric disorder Unstable medical problems Known congenital abnormality High risk pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl Oncken, MD MPH
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy

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