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OpenTrials
Completed

NCT Number: NCT00888979

Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy

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.

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Key information

Conditions

Tobacco Use Disorder Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hartford Hospital

Hartford, Connecticut, 06102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotrol Inhaler

Drug

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

Primary outcomes

  1. Number of Days of Inhaler Use

    Time frame: Baseline to 4 weeks

Secondary outcomes

  1. Cartridge Use

    Time frame: Baseline to 4 weeks

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

    Time frame: Baseline to 4 weeks

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Collaborators

  • UConn Health

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2014
First posted
Apr 28, 2009
Registry last updated
Jan 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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