Nicotine Substitute Prescribed at Hourly Intake or ad Libitum for Heavy Smokers Willing to Quit

Phase 4

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: Nasal Spray Nicotine Substitute (Experimental); Drug: Nasal Spray Nicotine Substitute (ad libitum)

• Registration Number: NCT00861276
• Lead Sponsor: University of Lausanne

Brief Summary

Objective: To assess the impact of instructional guidance in the regular use of use nicotine nasal spray (NNS) on the true use of NNS during the first three weeks of smoking cessation for heavy smokers who are willing to quit.

Methods: This randomized, open, controlled trial included 50 patients who were heavy smokers, were willing to quit, and attending an academic outpatient clinic in Western Switzerland. Patients were randomised to instruction on NNS use as "ad libitum" (administration whenever cravings appear; control group) or to use NNS at least every hour when awake (intervention group). Intakes were monitored using an electronic device fixed in the spray unit (MDILogTM) during the first three weeks of use. Self reported abstinence from smoking at six months was confirmed by expired-air carbon monoxide. Using intention-to-treat analysis, random-effect GLS regression was used to calculate the mean difference of daily doses between groups controlling for lack of independence between measures from the same individual.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-06
• Primary Completion: 2001-07
• Study Completion: 2001-12
• Status Verified: 2009-03
• Study First Submitted: 2009-03-12
• Study First Submitted QC: 2009-03-12
• Last Update Submitted: 2009-03-12
• Study First Posted: 2009-03-13
• Last Update Posted: 2009-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Highly dependent smokers in the stage of preparation according to Prochaska and Di Clemente's stages of change model

Exclusion Criteria

• History of myocardial infarction in the preceding 3 months
• Pregnancy or breast-feeding
• Use of any form of smokeless tobacco or other nicotine replacement therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Nasal Spray Nicotine Substitute (Experimental)	Arm instructed to use spray at least once an hour when awake.
2	Nasal Spray Nicotine Substitute (ad libitum)	Ad libitum: patients were instructed to use NNS when craving appears.

Primary Outcome Measures

Name	Time	Method
The daily number of intakes during the first three weeks recorded with an electronic device fixed on the spray unit (microswitch-actuated metered-dose inhaler chronology, MDILog™, model MDC-511, Medtrac, Denver, Colorado).	first 3 weeks

Secondary Outcome Measures

Name	Time	Method
self-reported continuous abstinence from smoking from the beginning of the substitution to the end of the 6th month of follow-up, validated by an expired-air carbon monoxide (CO) concentration of less than 10 parts per million (ppm)	6 months

Trial Locations

Locations (1)

Department of Ambulatory Care and Community Medicine; 🇨🇭 Lausanne, Vaud, Switzerland