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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
Last Update Posted : August 29, 2016
Information provided by (Responsible Party):

Study Description
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.

Study Design

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
Primary Completion Date : August 2016
Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :
  1. In-hospital mortality [ Time Frame: 30 days ]
  2. 30-day mortality [ Time Frame: On day 30 ]
    Last day study period

  3. 90-day mortality [ Time Frame: Day 90 followup ]
  4. Patient location [ Time Frame: On day 30, day 90 followup ]
  5. Total maximum SOFA score [ Time Frame: 30 days ]
    summing worst scores for each organ system

  6. Delta SOFA score [ Time Frame: 30 days ]
    total maximum SOFA score minus admission total SOFA score

  7. Mean RASS-score [ Time Frame: 30 days ]
  8. Highest RASS-score [ Time Frame: 30 days ]
  9. Lowest RASS-score [ Time Frame: 30 days ]
  10. Hours RASS-score outside optimal range (<-3 and/or >+1) [ Time Frame: 30 days ]
  11. Hours RASS-score outside optimal range (<-3 and/or >+1) indexed by the overall duration of sedation [ Time Frame: 30 days ]
  12. Hours with delirium [ Time Frame: 30 days ]
  13. Number of self-extubations [ Time Frame: 30 days ]
  14. Number of self-removed catheters [ Time Frame: 30 days ]
  15. Number of new nosocomial infections (CDC criteria) [ Time Frame: 30 days ]
  16. Total dose of sedatives, analgesics and antipsychotics in mg or μg/kg [ Time Frame: 30 days ]
  17. Hours of physical restraint [ Time Frame: 30 days ]
  18. Sedation-free hours [ Time Frame: 30 days ]
  19. Length of stay, ICU (hours) [ Time Frame: 30 days, day 90 followup ]
  20. Length of stay, hospital (hours) [ Time Frame: 30 days, day 90 followup ]
  21. Intensive Care Unit mortality [ Time Frame: 30 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

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

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
Principal Investigator: Ben Jong,de, MD Gelderse Vallei Hospital
More Information

Additional Information:

Responsible Party: drs. B. de Jong, MD, Gelderse Vallei Hospital
ClinicalTrials.gov Identifier: NCT01362959     History of Changes
Other Study ID Numbers: NicGoWell1.0
2011-002458-29 ( EudraCT Number )
First Posted: June 1, 2011    Key Record Dates
Last Update Posted: August 29, 2016
Last Verified: August 2016

Keywords provided by drs. B. de Jong, Gelderse Vallei Hospital:
Psychomotor Agitation
Substance Withdrawal Syndrome
Nicotine replacement therapy

Additional relevant MeSH terms:
Psychomotor Agitation
Substance Withdrawal Syndrome
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Psychomotor Disorders
Substance-Related Disorders
Chemically-Induced Disorders
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