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

• Tobacco Use Disorder

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