NCT01362959

Nicotine Replacement Therapy in the Intensive Care Unit

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Gelderse Vallei Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Delirium
• Psychomotor Agitation
• Substance Withdrawal Syndrome
• Nicotine Replacement Therapy

Interventions

Type	Name	Description
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	Cutaneous patch, containing no active substances	During the study period of thirty (30) days, the control product will be applicated daily.

Timeline

• Start date: 2012-06-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2011-06-01
• Last updated: 2018-10-10
• Results posted: 2018-10-10

Locations

2 sites across 1 country: Netherlands