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Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy

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ClinicalTrials.gov Identifier: NCT00888979
Recruitment Status : Completed
First Posted : April 28, 2009
Results First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Sponsor:
Collaborator:
UConn Health
Information provided by (Responsible Party):
Hartford Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Drug: Nicotrol Inhaler Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy
Study Start Date : April 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


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

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Sponsors and Collaborators
Hartford Hospital
UConn Health
Investigators
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Principal Investigator: Cheryl Oncken, MD MPH UConn Health
More Information
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Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT00888979    
Other Study ID Numbers: ONCK002885HU
H09-183-2 ( Other Identifier: Hartford Hospital )
First Posted: April 28, 2009    Key Record Dates
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:
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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