CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 154 enrolled
Drug / intervention
Nicotrol Inhaler +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01656733
NCT01656733Phase 4Completed
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Nicotine Replacement for Smoking Cessation During Pregnancy

UConn Health·interventional·Posted Aug 3, 2012·Updated Sep 30, 2019

In Brief

A Phase 4 clinical trial evaluating Nicotrol Inhaler and Placebo Inhaler for Nicotine Dependence and Smoking Cessation. Completed, enrolled 154 participants across 2 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNicotine Dependence, Smoking Cessation
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 3, 2012
Enrollment StartAug 1, 2012
Primary CompletionSep 30, 2017
Study CompletionOct 25, 2017
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 13.9 years ago

Interventions

Nicotrol Inhalerdrug

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

Placebo Inhalerdrug

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