NCT01362959

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2011

Completed
1 year until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

October 10, 2018

Completed
Last Updated

October 10, 2018

Status Verified

March 1, 2018

Enrollment Period

4.2 years

First QC Date

May 26, 2011

Results QC Date

March 3, 2018

Last Update Submit

March 3, 2018

Conditions

DeliriumPsychomotor AgitationSubstance Withdrawal SyndromeNicotine Replacement Therapy

Keywords

DeliriumPsychomotor AgitationSubstance Withdrawal SyndromeNicotine replacement therapy

Outcome Measures

Primary Outcomes (2)

  • 30-day Mortality

    30 days

  • Patient Location Day 30

    In the ICU or hospital at day 30

    On day 30

Secondary Outcomes (1)

  • 90-day Mortality

    Day 90 followup

Study Arms (2)

Nicotine patch

EXPERIMENTAL
Drug: Transdermal nicotine patch

Control patch

PLACEBO COMPARATOR

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

Interventions

Transdermal nicotine patchDRUG

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.

Also known as: Nicotinell patch, regulated delivery 35 mg. RVG 14830, Nicotinell patch, regulated delivery 52.5 mg. RVG 14831
Nicotine patch
Cutaneous patch, containing no active substancesOTHER

During the study period of thirty (30) days, the control product will be applicated daily.

Control patch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gelderse Vallei Hospital

Ede, Gelderland, 6716 RP, Netherlands

Location

Deventer Hospital

Deventer, Overijssel, 7416 SE, Netherlands

Location

Related Publications (16)

  • Hays JT, Ebbert JO. Adverse effects and tolerability of medications for the treatment of tobacco use and dependence. Drugs. 2010 Dec 24;70(18):2357-72. doi: 10.2165/11538190-000000000-00000.

    PMID: 21142259BACKGROUND

  • Moss M, Burnham EL. Alcohol abuse in the critically ill patient. Lancet. 2006 Dec 23;368(9554):2231-42. doi: 10.1016/S0140-6736(06)69490-7.

    PMID: 17189035BACKGROUND

  • Benowitz NL. Nicotine addiction. N Engl J Med. 2010 Jun 17;362(24):2295-303. doi: 10.1056/NEJMra0809890. No abstract available.

    PMID: 20554984BACKGROUND

  • Hatsukami DK, Stead LF, Gupta PC. Tobacco addiction. Lancet. 2008 Jun 14;371(9629):2027-38. doi: 10.1016/S0140-6736(08)60871-5.

    PMID: 18555914BACKGROUND

  • Mills EJ, Wu P, Lockhart I, Wilson K, Ebbert JO. Adverse events associated with nicotine replacement therapy (NRT) for smoking cessation. A systematic review and meta-analysis of one hundred and twenty studies involving 177,390 individuals. Tob Induc Dis. 2010 Jul 13;8(1):8. doi: 10.1186/1617-9625-8-8.

    PMID: 20626883BACKGROUND

  • Lucidarme O, Seguin A, Daubin C, Ramakers M, Terzi N, Beck P, Charbonneau P, du Cheyron D. Nicotine withdrawal and agitation in ventilated critically ill patients. Crit Care. 2010;14(2):R58. doi: 10.1186/cc8954. Epub 2010 Apr 9.

    PMID: 20380688BACKGROUND

  • Mayer SA, Chong JY, Ridgway E, Min KC, Commichau C, Bernardini GL. Delirium from nicotine withdrawal in neuro-ICU patients. Neurology. 2001 Aug 14;57(3):551-3. doi: 10.1212/wnl.57.3.551.

    PMID: 11502936BACKGROUND

  • Moreno R, Vincent JL, Matos R, Mendonca A, Cantraine F, Thijs L, Takala J, Sprung C, Antonelli M, Bruining H, Willatts S. The use of maximum SOFA score to quantify organ dysfunction/failure in intensive care. Results of a prospective, multicentre study. Working Group on Sepsis related Problems of the ESICM. Intensive Care Med. 1999 Jul;25(7):686-96. doi: 10.1007/s001340050931.

    PMID: 10470572BACKGROUND

  • Lee AH, Afessa B. The association of nicotine replacement therapy with mortality in a medical intensive care unit. Crit Care Med. 2007 Jun;35(6):1517-21. doi: 10.1097/01.CCM.0000266537.86437.38.

    PMID: 17452926BACKGROUND

  • Paciullo CA, Short MR, Steinke DT, Jennings HR. Impact of nicotine replacement therapy on postoperative mortality following coronary artery bypass graft surgery. Ann Pharmacother. 2009 Jul;43(7):1197-202. doi: 10.1345/aph.1L423. Epub 2009 Jun 30.

    PMID: 19567657BACKGROUND

  • Seder DB, Schmidt JM, Badjatia N, Fernandez L, Rincon F, Claassen J, Gordon E, Carrera E, Kurtz P, Lee K, Connolly ES, Mayer SA. Transdermal nicotine replacement therapy in cigarette smokers with acute subarachnoid hemorrhage. Neurocrit Care. 2011 Feb;14(1):77-83. doi: 10.1007/s12028-010-9456-9.

    PMID: 20949331BACKGROUND

  • Cartin-Ceba R, Warner DO, Hays JT, Afessa B. Nicotine replacement therapy in critically ill patients: a prospective observational cohort study. Crit Care Med. 2011 Jul;39(7):1635-40. doi: 10.1097/CCM.0b013e31821867b8.

    PMID: 21494111BACKGROUND

  • Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available.

    PMID: 18538699BACKGROUND

  • Centers for Disease Control and Prevention (CDC). Vital signs: central line-associated blood stream infections--United States, 2001, 2008, and 2009. MMWR Morb Mortal Wkly Rep. 2011 Mar 4;60(8):243-8.

    PMID: 21368740BACKGROUND

  • Hsieh SJ, Ware LB, Eisner MD, Yu L, Jacob P 3rd, Havel C, Goniewicz ML, Matthay MA, Benowitz NL, Calfee CS. Biomarkers increase detection of active smoking and secondhand smoke exposure in critically ill patients. Crit Care Med. 2011 Jan;39(1):40-5. doi: 10.1097/CCM.0b013e3181fa4196.

    PMID: 20935560BACKGROUND

  • de Jong B, Schuppers AS, Kruisdijk-Gerritsen A, Arbouw MEL, van den Oever HLA, van Zanten ARH. The safety and efficacy of nicotine replacement therapy in the intensive care unit: a randomised controlled pilot study. Ann Intensive Care. 2018 Jun 7;8(1):70. doi: 10.1186/s13613-018-0399-1.

    PMID: 29881956DERIVED

Related Links

MeSH Terms

Conditions

DeliriumPsychomotor AgitationSubstance Withdrawal Syndrome

Interventions

Tobacco Use Cessation DevicesTransdermal Patch

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersDyskinesiasPsychomotor DisordersAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

TherapeuticsEquipment and Supplies

Limitations and Caveats

Pilot study, therefore small numbers

Results Point of Contact

Title
Dr. Huub van den Oever
Organization
Department of Intensive care, Deventer Hospital
h.vandenoever@dz.nl
+31 570 535346

Study Officials

  • Ben Jong,de, MD

    Gelderse Vallei Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 26, 2011

First Posted

June 1, 2011

Study Start

June 1, 2012

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

October 10, 2018

Results First Posted

October 10, 2018

Record last verified: 2018-03

Locations

NL(2)