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Nicotine Replacement Therapy in the Intensive Care Unit

NCT01362959 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2018-10-10

Study results available
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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.

Conditions

  • Delirium
  • Psychomotor Agitation
  • Substance Withdrawal Syndrome
  • Nicotine Replacement Therapy

Interventions

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

Cutaneous patch, containing no active substances

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

Sponsors & Collaborators

  • Deventer Ziekenhuis

    collaborator OTHER

  • Wageningen University

    collaborator OTHER

  • Gelderse Vallei Hospital

    lead OTHER

Principal Investigators

  • Ben Jong,de, MD · Gelderse Vallei Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01362959 on ClinicalTrials.gov