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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Drug: Nicotrol Inhaler

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Days of Inhaler Use	Baseline to 4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Cartridge Use	Baseline to 4 weeks
Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks.	Baseline to 4 weeks

Collaborators and Investigators

• Sponsor: Hartford Hospital
• Collaborators: UConn Health
• Investigators: Principal Investigator: Cheryl Oncken, MD MPH, UConn Health

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: April 24, 2009
• First Submitted That Met QC Criteria: April 27, 2009
• First Posted (Estimate): April 28, 2009

Study Record Updates

• Last Update Posted (Estimate): January 9, 2017
• Last Update Submitted That Met QC Criteria: November 10, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Smoking Cessation during Pregnancy; Nicotrol Inhaler
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: ONCK002885HU; H09-183-2 (Other Identifier: Hartford Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No