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Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00888979
First Posted: April 28, 2009
Last Update Posted: January 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
UConn Health
Information provided by (Responsible Party):
Hartford Hospital
  Purpose
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.

Condition Intervention
Tobacco Use Disorder Drug: Nicotrol Inhaler

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy

Resource links provided by NLM:


Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • Number of Days of Inhaler Use [ Time Frame: Baseline to 4 weeks ]

Secondary Outcome Measures:
  • Cartridge Use [ Time Frame: Baseline to 4 weeks ]
  • Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks. [ Time Frame: Baseline to 4 weeks ]

Enrollment: 10
Study Start Date: April 2009
Study Completion Date: April 2014
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nicotrol with Behavioral Counseling
Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
Drug: Nicotrol Inhaler
10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888979


Locations
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Sponsors and Collaborators
Hartford Hospital
UConn Health
Investigators
Principal Investigator: Cheryl Oncken, MD MPH UConn Health
  More Information

Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT00888979     History of Changes
Other Study ID Numbers: ONCK002885HU
H09-183-2 ( Other Identifier: Hartford Hospital )
First Submitted: April 24, 2009
First Posted: April 28, 2009
Results First Submitted: July 10, 2015
Results First Posted: January 9, 2017
Last Update Posted: January 9, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hartford Hospital:
Smoking Cessation during Pregnancy
Nicotrol Inhaler

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action