Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT01656733
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2012-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nicotine Replacement for Smoking Cessation During Pregnancy
Sponsor:
UConn Health
Organization:
Study Overview
Official Title:
Nicotine Replacement for Smoking Cessation During Pregnancy
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01HD069314-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |