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

Smoking Cessation Clinical Trial

— SUNIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00861276
• Other study ID #: Prot 29/99
• Status: Completed
• Phase: Phase 4
• First received: March 12, 2009
• Last updated: March 12, 2009
• Start date: June 2000
• Est. completion date: December 2001

Study information

• Verified date: March 2009
• Source: University of Lausanne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2001
• Est. primary completion date: July 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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).
• 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.

Locations

Country	Name	City	State
Switzerland	Department of Ambulatory Care and Community Medicine	Lausanne	Vaud

Sponsors (2)

Lead Sponsor	Collaborator
University of Lausanne	Pharmacia

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No