Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nicotine Replacement Therapy in the Intensive Care Unit (NicGoWell)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01362959
Recruitment Status : Completed
First Posted : June 1, 2011
Results First Posted : October 10, 2018
Last Update Posted : October 10, 2018
Sponsor:
Collaborators:
Deventer Ziekenhuis
Wageningen University
Information provided by (Responsible Party):
drs. B. de Jong, Gelderse Vallei Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Delirium Psychomotor Agitation Substance Withdrawal Syndrome Nicotine Replacement Therapy Drug: Transdermal nicotine patch Other: Cutaneous patch, containing no active substances Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nicotine Replacement Therapy in the Intensive Care Unit: a Randomized, Controlled Pilot Study
Study Start Date : June 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 30-day Mortality [ Time Frame: 30 days ]
  2. Patient Location Day 30 [ Time Frame: On day 30 ]
    In the ICU or hospital at day 30


Secondary Outcome Measures :
  1. 90-day Mortality [ Time Frame: Day 90 followup ]
    Mortality at day 90 after enrollment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362959


Locations
Layout table for location information
Netherlands
Gelderse Vallei Hospital
Ede, Gelderland, Netherlands, 6716 RP
Deventer Hospital
Deventer, Overijssel, Netherlands, 7416 SE
Sponsors and Collaborators
Gelderse Vallei Hospital
Deventer Ziekenhuis
Wageningen University
Investigators
Layout table for investigator information
Principal Investigator: Ben Jong,de, MD Gelderse Vallei Hospital

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: drs. B. de Jong, MD, Gelderse Vallei Hospital
ClinicalTrials.gov Identifier: NCT01362959    
Other Study ID Numbers: NicGoWell1.0
2011-002458-29 ( EudraCT Number )
First Posted: June 1, 2011    Key Record Dates
Results First Posted: October 10, 2018
Last Update Posted: October 10, 2018
Last Verified: March 2018
Keywords provided by drs. B. de Jong, Gelderse Vallei Hospital:
Delirium
Psychomotor Agitation
Substance Withdrawal Syndrome
Nicotine replacement therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Delirium
Psychomotor Agitation
Substance Withdrawal Syndrome
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Psychomotor Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action