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
|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|
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 (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|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.
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.
- 30-day Mortality [ Time Frame: 30 days ]
- Patient Location Day 30 [ Time Frame: On day 30 ]In the ICU or hospital at day 30
- 90-day Mortality [ Time Frame: Day 90 followup ]Mortality at day 90 after enrollment
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, Overijssel, Netherlands, 7416 SE|
|Principal Investigator:||Ben Jong,de, MD||Gelderse Vallei Hospital|