Nicotine Substitute Prescribed at Hourly Intake or ad Libitum for Heavy Smokers Willing to Quit (SUNIC)
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.
|Smoking Cessation||Drug: Nasal Spray Nicotine Substitute (Experimental) Drug: Nasal Spray Nicotine Substitute (ad libitum)||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||Use of Nicotine Substitute Prescribed at Hourly Intake or ad Libitum for Heavy Smokers Willing to Quit: a Randomized Controlled Trial|
- 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). [ Time Frame: first 3 weeks ]
- 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) [ Time Frame: 6 months ]
|Study Start Date:||June 2000|
|Study Completion Date:||December 2001|
|Primary Completion Date:||July 2001 (Final data collection date for primary outcome measure)|
Arm instructed to use spray at least once an hour when awake.
Drug: Nasal 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).
Other Name: Nicorette(R) nasal spray
Active Comparator: 2
Ad libitum: patients were instructed to use NNS when craving appears.
Drug: Nasal Spray Nicotine Substitute (ad libitum)
In the control group, participants were instructed to use NNS as needed to suppress withdrawal symptoms when cravings appeared.
Other Name: Nicorette(R) Nasal Spray
Please refer to this study by its ClinicalTrials.gov identifier: NCT00861276
|Department of Ambulatory Care and Community Medicine|
|Lausanne, Vaud, Switzerland, 1011|
|Study Director:||Jean-Pierre Zellweger, MD||Department of Ambulatory Care and Community Medicine, University of Lausanne|