Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy

Hartford Hospital

Status: Completed

Conditions: Tobacco Use Disorder

Treatments: Drug: Nicotrol Inhaler

Study type: Interventional

Funder types: Other

Identifiers

NCT00888979

H09-183-2 (Other Identifier)

ONCK002885HU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Nicotrol with Behavioral Counseling

Experimental group

Description:

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

Treatment:

Drug: Nicotrol Inhaler