Nicotine Replacement Therapy in the Intensive Care Unit (NicGoWell)

March 3, 2018 updated by: drs. B. de Jong, Gelderse Vallei Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Ede, Gelderland, Netherlands, 6716 RP
        • Gelderse Vallei Hospital
    • Overijssel
      • Deventer, Overijssel, Netherlands, 7416 SE
        • Deventer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • Pregnancy
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nicotine patch
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
Placebo Comparator: Control patch
The control product is a look-alike patch compared to the test product, containing no nicotine or other active substances.
Other: Cutaneous patch, containing no active substances
During the study period of thirty (30) days, the control product will be applicated daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day Mortality
Time Frame: 30 days
30 days
Patient Location Day 30
Time Frame: On day 30
In the ICU or hospital at day 30
On day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
90-day Mortality
Time Frame: Day 90 followup
Mortality at day 90 after enrollment
Day 90 followup

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gelderse Vallei Hospital

Collaborators

Wageningen University
Deventer Ziekenhuis

Investigators

  • Principal Investigator: Ben Jong,de, MD, Gelderse Vallei Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

May 26, 2011

First Submitted That Met QC Criteria

May 27, 2011

First Posted (Estimate)

June 1, 2011

Study Record Updates

Last Update Posted (Actual)

October 10, 2018

Last Update Submitted That Met QC Criteria

March 3, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NicGoWell1.0
  • 2011-002458-29 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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