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Nicotine Replacement for Smoking Cessation During Pregnancy

Primary Purpose

Nicotine Dependence, Smoking Cessation

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Nicotrol Inhaler

Placebo Inhaler

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring Smoking Cessation, Pregnancy, Nicotrol Inhaler, Placebo Inhaler, Nicotine Inhaler

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

smoking at least 5 cigarettes per day for the preceding 7 days
previous attempt to quit smoking during pregnancy by self report
13-26 weeks gestation
at least 16 years of age
able to speak English or Spanish
intent to carry pregnancy to term
stable residence

Exclusion Criteria:

current drug or alcohol abuse or dependence (other than methadone maintenance)
twins or other multiple gestation
unstable psychiatric disorder
unstable medical problems (e.g., pre-eclampsia, threatened abortion, hyperemesis gravidarum)
known congenital abnormality

Sites / Locations

Women's Ambulatory Health Services at Hartford Hospital
Wesson Women's Clinic at Baystate Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nicotrol Inhaler

Placebo Inhaler

Arm Description

Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.

Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper

Outcomes

Primary Outcome Measures

Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days

Number of participants who self report an average of zero cigarettes smoked per day in preceding 7 days

Secondary Outcome Measures

Exhaled Carbon Monoxide

As measured by parts per million (ppm) on CO breathalyzer

Birth Weight

Birth weight in grams

Gestational Age

Measure of age of pregnancy at delivery

Full Information

NCT ID

NCT01656733

First Posted

August 1, 2012

Last Updated

September 27, 2019

Sponsor

UConn Health

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

1. Study Identification

Unique Protocol Identification Number

NCT01656733

Brief Title

Nicotine Replacement for Smoking Cessation During Pregnancy

Official Title

Nicotine Replacement for Smoking Cessation During Pregnancy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

September 30, 2017 (Actual)

Study Completion Date

October 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

UConn Health

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a clinical trial to determine if the nicotine inhaler in combination with counseling will help pregnant women quit smoking, and whether it is safe when compared to placebo (an inactive inhaler).

Detailed Description

This project will examine the safety and efficacy of the nicotine inhaler as an aid to smoking cessation during pregnancy. The specific aims are: (1) To examine the efficacy of the nicotine inhaler compared to a matching placebo for smoking cessation during pregnancy; (2) To compare the nicotine inhaler with placebo on overall nicotine exposure (i.e., serum cotinine concentrations), and on birth outcomes (i.e., birth weight and gestational age); (3) To identify factors that determine which women benefit most from the use of the nicotine inhaler for smoking cessation during pregnancy; (4) To explore mechanisms by which the nicotine inhaler increases birth weight and gestational age. Subjects will be recruited from two prenatal clinics that serve primarily a low-income, minority population. Pregnant smokers (n=270) who smoke at least 5 cigarettes/ day will receive nurse-delivered behavioral counseling and be randomized to receive a 6-week course of treatment with either a nicotine inhaler or placebo, followed by a 6-week taper. Birth outcomes will be obtained on all participants

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nicotine Dependence, Smoking Cessation

Keywords

Smoking Cessation, Pregnancy, Nicotrol Inhaler, Placebo Inhaler, Nicotine Inhaler

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

154 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nicotrol Inhaler

Arm Type

Experimental

Arm Description

Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.

Arm Title

Placebo Inhaler

Arm Type

Placebo Comparator

Arm Description

Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper

Intervention Type

Drug

Intervention Name(s)

Nicotrol Inhaler

Other Intervention Name(s)

Nicotine Inhaler

Intervention Description

Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper

Intervention Type

Drug

Intervention Name(s)

Placebo Inhaler

Intervention Description

Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper

Primary Outcome Measure Information:

Title

Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days

Description

Number of participants who self report an average of zero cigarettes smoked per day in preceding 7 days

Time Frame

32-34 weeks gestation (Visit 6)

Secondary Outcome Measure Information:

Title

Exhaled Carbon Monoxide

Description

As measured by parts per million (ppm) on CO breathalyzer

Time Frame

32-34 weeks gestation

Title

Birth Weight

Description

Birth weight in grams

Time Frame

At delivery

Title

Gestational Age

Description

Measure of age of pregnancy at delivery

Time Frame

At delivery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: smoking at least 5 cigarettes per day for the preceding 7 days previous attempt to quit smoking during pregnancy by self report 13-26 weeks gestation at least 16 years of age able to speak English or Spanish intent to carry pregnancy to term stable residence Exclusion Criteria: current drug or alcohol abuse or dependence (other than methadone maintenance) twins or other multiple gestation unstable psychiatric disorder unstable medical problems (e.g., pre-eclampsia, threatened abortion, hyperemesis gravidarum) known congenital abnormality

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cheryl Oncken, M.D., M.P.H.

Organizational Affiliation

UConn Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Women's Ambulatory Health Services at Hartford Hospital

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06106

Country

United States

Facility Name

Wesson Women's Clinic at Baystate Medical Center

City

Springfield

State/Province

Massachusetts

ZIP/Postal Code

01199

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

31380506

Citation

Oncken C, Dornelas EA, Kuo CL, Sankey HZ, Kranzler HR, Mead EL, Thurlow MSD. Randomized Trial of Nicotine Inhaler for Pregnant Smokers. Am J Obstet Gynecol MFM. 2019 Mar;1(1):10-18. doi: 10.1016/j.ajogmf.2019.03.006. Epub 2019 Mar 27.

Results Reference

derived

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Nicotine Replacement for Smoking Cessation During Pregnancy

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