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NCT00888979 Clinical Trial

Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy

Tobacco Use Disorder Clinical Trial

Official title:
Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00888979
Other study ID # ONCK002885HU
Secondary ID H09-183-2
Status Recruiting
Phase N/A
First received April 24, 2009
Last updated February 23, 2010
Start date April 2009
Est. completion date November 2010

Study information
Verified date February 2010
Source Hartford Hospital
Contact Cheryl Oncken, MD
Phone 860-679-3425
Email oncken@nso2.uchc.edu
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date November 2010
Est. primary completion date June 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Hartford Hospital Hartford Connecticut

Sponsors (2)
Lead Sponsor Collaborator
Hartford Hospital University of Connecticut Health Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cigarette abstinence At 2 and 4 weeks after quit date. No
Secondary Cotinine concentrations At 2 and 4 weeks after treatment compared to baseline levels while smoking No
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