CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 47 enrolled
Drug / intervention
Transdermal nicotine patch +1 moredrug
Likely dose
Transdermal nicotine patch 14 mgfrom 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/NCT01362959
NCT01362959Phase 4Completed
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Nicotine Replacement Therapy in the Intensive Care Unit: a Randomized, Controlled Pilot Study

Gelderse Vallei Hospital·interventional·Posted Jun 1, 2011·Updated Oct 10, 2018

In Brief

A Phase 4 clinical trial evaluating Transdermal nicotine patch and Cutaneous patch, containing no active substances for Delirium and 3 related conditions. Completed, enrolled 47 participants across 2 sites.

Detailed Summary

The purpose of this study is to determine whether transdermal nicotine replacement therapy is safe and effective for treating nicotine withdrawal symptoms in the critically ill smoking patient.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDelirium, Psychomotor Agitation, Substance Withdrawal Syndrome, Nicotine Replacement Therapy
CountriesNetherlands
CollaboratorsDeventer Ziekenhuis, Wageningen University

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 1, 2011
Enrollment StartJun 1, 2012
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 15.1 years ago

Interventions

Transdermal nicotine patchdrug

The test product is a transdermal nicotine patch. The dosage of the test product depends on the amount of cigarettes used by a specific patient (21 or more or less than 21) delivering 21 or 14 mg nicotine/24 hrs. During the study period of thirty (30) days a patch will be applicated daily.

Cutaneous patch, containing no active substancesother

During the study period of thirty (30) days, the control product will be applicated daily.