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Trial record 54 of 2035 for:    Smoking Cessation

In-patient Smoking Cessation Intervention Using Counseling, Spirometry and Nicotine Replacement Therapy

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ClinicalTrials.gov Identifier: NCT02470923
Recruitment Status : Unknown
Verified May 2015 by Soroka University Medical Center.
Recruitment status was:  Recruiting
First Posted : June 12, 2015
Last Update Posted : August 25, 2015
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Soroka University Medical Center

Brief Summary:

The objective of the study is to assess the effect of in-hospital intensive counseling and NRT (nicotine replacement therapy) vs. usual care, on smoking cessation or enrollment to smoking cessation behavioral intervention.

This is prospective randomized clinical trial. The study population will include smokers subjects admitted to internal medicine departments at Soroka University Medical Center.

The study population will be divided randomly into three arms according to intervention intensity (ratio 1:1:1).


Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Nicotine replacement therapy Behavioral: Intensive counseling Behavioral: Medical advice Not Applicable

Detailed Description:

Prospective randomized clinical trial. The study population will include smokers subjects admitted to internal medicine departments at Soroka University Medical Center.

The study population will be divided randomly into three arms according to intervention intensity (ratio 1:1:1):

Group 1 - Usual care including medical advice to quit and confrontation with abnormal spirometry results if relevant.

Group 2 - Intensive counseling (15 minutes) by a smoking cessation counselor including confrontation with abnormal spirometry results if relevant, and follow up for at least 5 weeks after discharge (will be done weekly by phone for five consecutive weeks).

Group 3 - Intensive counseling (15 minutes) by a smoking cessation counselor including confrontation with abnormal spirometry results if relevant, offering and providing nicotine replacement therapy (NRT) and follow up (will be done weekly by phone for five consecutive weeks).

All participants will be given a smoking cessation leaflet.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: In-patient Smoking Cessation Intervention Using Counseling, Spirometry and Nicotine Replacement Therapy
Study Start Date : August 2015
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Group 1
Usual care including medical advice to quit and confrontation with abnormal spirometry results if relevant.
Behavioral: Medical advice
Group 2
Intensive counseling (15 minutes) by a smoking cessation counselor including confrontation with abnormal spirometry results if relevant, and follow up for at least 5 weeks after discharge (will be done weekly by phone for five consecutive weeks).
Behavioral: Intensive counseling
Group 3
Intensive counseling (15 minutes) by a smoking cessation counselor including confrontation with abnormal spirometry results if relevant, offering and providing nicotine replacement therapy (NRT) and follow up (will be done weekly by phone for five consecutive weeks).
Drug: Nicotine replacement therapy



Primary Outcome Measures :
  1. Composite outcome: •Enrollment to a cessation behavioral intervention program according to participation in first two meetings of group therapy or personal counseling • Smoking cessation validated by CO exhale test<5 ppm [ Time Frame: Within six months since discharge ]
    The need for composite primary outcome based on the hypothesis that in Israel, the best supported way to quit smoking in by participating in group or personal counseling, with 50% success rate of smoking cessation.



Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Admitted to Internal Medicine at Soroka University Medical Center.
  2. Current cigarette smokers (≥ 10 cigarettes per day)
  3. Provided written informed consent.

Exclusion Criteria:

  1. Substance abuse (except for tobacco).
  2. Handicapped or bed ridden patients.
  3. Patients who don't speak Hebrew, English, Russian or Arabic.
  4. Medically not suitable for NRT-decided by physician on the basis of the patient's medical file.

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): NCT02470923


Contacts
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Contact: Tali Shafat, MD 2li.shafat@gmail.com
Contact: Nimrod Maimon, MD nimrod.maimon@clalit.org.il

Locations
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Israel
Soroka University Medical Center Recruiting
Be'er-Sheva, Israel, 8410101
Contact: Tali Shafat, MD         
Sponsors and Collaborators
Soroka University Medical Center
Novartis

Publications of Results:
US Department of Health & Human Services. The Health Consequences of Smoking: A Report of the Surgeon General. 2004. Accessed at www.surgeongeneral.gov/library/smokingconsequences/ on October 31, 2011.
Fiore MC, Jaén CR, Baker TB, et al: Clinical practice guideline: treating tobacco use and dependence: 2008 update. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service. Retrieved 2011-02-16.
Israel health ministry report 2010, Accessed at: http://www.old.health.gov.il/download/pages/smoke10_290511.pdf

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Responsible Party: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT02470923     History of Changes
Other Study ID Numbers: SOR-0180-12-CTIL
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: August 25, 2015
Last Verified: May 2015

Keywords provided by Soroka University Medical Center:
Smoking cessation
Nicotine
Spirometry
Internal medicine

Additional relevant MeSH terms:
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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