Nicotine Substitute Prescribed at Hourly Intake or ad Libitum for Heavy Smokers Willing to Quit (SUNIC)
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|ClinicalTrials.gov Identifier: NCT00861276|
Recruitment Status : Completed
First Posted : March 13, 2009
Last Update Posted : March 13, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Drug: Nasal Spray Nicotine Substitute (Experimental) Drug: Nasal Spray Nicotine Substitute (ad libitum)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Use of Nicotine Substitute Prescribed at Hourly Intake or ad Libitum for Heavy Smokers Willing to Quit: a Randomized Controlled Trial|
|Study Start Date :||June 2000|
|Actual Primary Completion Date :||July 2001|
|Actual Study Completion Date :||December 2001|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|