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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02470923
• Other study ID #: SOR-0180-12-CTIL
• Status: Recruiting
• Phase: N/A
• First received: June 10, 2015
• Last updated: August 24, 2015
• Start date: August 2015
• Est. completion date: July 2017

Study information

• Verified date: May 2015
• Source: Soroka University Medical Center
• Contact: Tali Shafat, MD
• Email: 2li.shafat[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Nicotine replacement therapy

Behavioral:
• Intensive counseling

• Medical advice

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Be'er-Sheva

Sponsors (2)

Lead Sponsor	Collaborator
Soroka University Medical Center	Novartis

Country where clinical trial is conducted

Israel, 

References & Publications (11)

Fiore MC, Goplerud E, Schroeder SA. The Joint Commission's new tobacco-cessation measures--will hospitals do the right thing? N Engl J Med. 2012 Mar 29;366(13):1172-4. doi: 10.1056/NEJMp1115176. Epub 2012 Mar 14. — View Citation

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

Kotz D, Wesseling G, Huibers MJ, van Schayck OC. Efficacy of confronting smokers with airflow limitation for smoking cessation. Eur Respir J. 2009 Apr;33(4):754-62. doi: 10.1183/09031936.00116308. Epub 2009 Jan 7. — View Citation

McRobbie H, Hajek P. Nicotine replacement therapy in patients with cardiovascular disease: guidelines for health professionals. Addiction. 2001 Nov;96(11):1547-51. Review. — View Citation

Rigotti NA, Arnsten JH, McKool KM, Wood-Reid KM, Singer DE, Pasternak RC. The use of nicotine-replacement therapy by hospitalized smokers. Am J Prev Med. 1999 Nov;17(4):255-9. — View Citation

Rigotti NA, Munafo MR, Stead LF. Smoking cessation interventions for hospitalized smokers: a systematic review. Arch Intern Med. 2008 Oct 13;168(18):1950-60. doi: 10.1001/archinte.168.18.1950. Review. — View Citation

Silagy C, Lancaster T, Stead L, Mant D, Fowler G. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2004;(3):CD000146. Review. Update in: Cochrane Database Syst Rev. 2008;(1):CD000146. — View Citation

Stead LF, Lancaster T. Group behaviour therapy programmes for smoking cessation. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD001007. Review. — View Citation

Thabane M; COPD Working Group. Smoking cessation for patients with chronic obstructive pulmonary disease (COPD): an evidence-based analysis. Ont Health Technol Assess Ser. 2012;12(4):1-50. Epub 2012 Mar 1. Review. — View Citation

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.

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Within six months since discharge	No