Smoking Cessation
Conditions
Keywords
Smoking Cessation, Nicotine, Administration and dosage, Randomized Controlled Trial
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.
Interventions
DRUGNasal Spray Nicotine Substitute (Experimental)
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).
DRUGNasal Spray Nicotine Substitute (ad libitum)
In the control group, participants were instructed to use NNS as needed to suppress withdrawal symptoms when cravings appeared.
Sponsors
Pharmacia
University of Lausanne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Switzerland
Outcome results
None listed