Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy

NCT00888979 | Completed Results

• 2 other identifiers: ONCK002885HUH09-183-2
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder

Keywords

Smoking Cessation during Pregnancy; Nicotrol Inhaler

Outcome Measures

Primary Outcomes (1)

• Number of Days of Inhaler Use

  Baseline to 4 weeks

Secondary Outcomes (2)

• Cartridge Use

  Baseline to 4 weeks

• Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks.

  Baseline to 4 weeks

Study Arms (1)

Nicotrol with Behavioral Counseling

EXPERIMENTAL

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

Drug: Nicotrol Inhaler

Interventions

Nicotrol Inhaler DRUG

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

Nicotrol with Behavioral Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford Hospital: lead
• UConn Health: collaborator

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Cheryl Oncken
• Organization: UConn Health

oncken@uchc.edu

860-679-3425

Study Officials

• Cheryl Oncken, MD MPH

  UConn Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2009
• First Posted: April 28, 2009
• Study Start: April 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: April 1, 2014
• Last Updated: January 9, 2017
• Results First Posted: January 9, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)