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

Study Overview
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Brief Summary
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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.

Official Title
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Use of Nicotine Substitute Prescribed at Hourly Intake or ad Libitum for Heavy Smokers Willing to Quit: a Randomized Controlled Trial

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Nasal Spray Nicotine Substitute (Experimental)
* Drug: Nasal Spray Nicotine Substitute (ad libitum)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Arm instructed to use spray at least once an hour when awake. | Drug: Nasal Spray Nicotine Substitute (Experimental)<br>* During the first month, subjects in the intervention group received instruction from the physician to use NNS regularly (at least 2 puffs/hour, for an average of 1 mg nicotine/hour when awake).<br>* Other names: Nicorette(R) nasal spray;|
| Active Comparator: 2<br>Ad libitum: patients were instructed to use NNS when craving appears. | Drug: Nasal Spray Nicotine Substitute (ad libitum)<br>* In the control group, participants were instructed to use NNS as needed to suppress withdrawal symptoms when cravings appeared.<br>* Other names: Nicorette(R) Nasal Spray;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation, Nicotine, Administration and dosage, Randomized Controlled Trial