Nicotine Replacement Therapy in the Intensive Care Unit
Nicotine Replacement Therapy in the Intensive Care Unit: a Randomized, Controlled Pilot Study
  • Phase

    Phase 4
  • Study Type

  • Intervention/Treatment

    nicotine ...
  • Study Participants

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.
Cigarette smoking remains the leading cause of preventable disease and premature death worldwide. There are about 1.2 billion smokers in the world, half of whom will die from diseases caused by smoking. Smoking causes 5 million deaths per year, and if present trends continue, 10 million smokers per year are projected to die by 2025.

Furthermore, abstinence from the highly addictive tobacco products can lead to withdrawal symptoms. Although these symptoms are non-life threatening in healthy and hospitalized adults they are not well described in the mechanically ventilated active smoking patient.

Retrospective studies found a higher, lower or equal mortality in critically ill patients receiving nicotine replacement therapy compared to patients receiving no nicotine replacement.

Because of these conflicting results and the absence of a randomized controlled trial studying the efficacy and safety of transdermal nicotine replacement therapy in the critically ill smoking patient a clinical study will be conducted.
Study Started
Jun 30
Primary Completion
Aug 31
Study Completion
Aug 31
Results Posted
Oct 10
Last Update
Oct 10

Drug Transdermal nicotine patch

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.

  • Other names: Nicotinell patch, regulated delivery 35 mg. RVG 14830, Nicotinell patch, regulated delivery 52.5 mg. RVG 14831

Other Cutaneous patch, containing no active substances

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

Nicotine patch Experimental

Control patch Placebo Comparator

The control product is a look-alike patch compared to the test product, containing no nicotine or other active substances.


Inclusion Criteria: Any patient admitted to the intensive care unit must meet all of the following criteria to be eligible for the study:

Critically ill active smoking patient
Being mechanically ventilated
Start of study product application within 48 hours after ICU admission
Expected to be mechanically ventilated for more than 48 hours after start of application of the study product

Exclusion Criteria: Any patient admitted to the intensive care unit meeting one or more of the following criteria is not eligible for the study:

Patient younger than 18 years
Patient or next of kin denying research authorization
Breastfeeding women
History of chronic dementia or psychosis
(Acute) neurologic disease on admission, possibly confounding study objectives (TBI, stroke, ICH/SAH, seizures, meningitis, encephalitis, intracranial tumor)
Patient receiving any form of NRT within two weeks before admission
Patient not understanding Dutch
Patient with acute myocardial infarction
Patient with severe cardiac arrhythmia
Patient with unstable or deteriorating angina pectoris
Patient with generalized acute or chronic skin diseases interfering with NRT absorption
Patient with severe hearing deficiency
Moribund patient
Patient with known hypersensibility to nicotine or components of the transdermal therapeutic system
Patient with known hypersensibility to patches
Patient participating in an other study


Nicotine Replacement


All Events

Event Type Organ System Event Term Nicotine Replacement Control

30-day Mortality

Nicotine Replacement

percentage of patients


percentage of patients

Patient Location Day 30

In the ICU or hospital at day 30

Nicotine Replacement


90-day Mortality

Mortality at day 90 after enrollment

Nicotine Replacement

percentage of patients


percentage of patients

Time in Normal Brain Function D20

Time spent alive without delirium and without sedation or coma

Nicotine Replacement

hours (Median)
Inter-Quartile Range: 316.0 to 448.0


hours (Median)
Inter-Quartile Range: 110.0 to 432.0

Time in Normal Brain Function D10

Time alive without delirium and without sedation or coma

Nicotine Replacement

hours (Median)
Inter-Quartile Range: 96.0 to 216.0


hours (Median)
Inter-Quartile Range: 20.0 to 210.0



Age, Continuous

years (Mean)
Standard Deviation: 10.0

Region of Enrollment

Sex: Female, Male

Overall Study

Nicotine Patch

Control Patch