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

Sponsor
University of Lausanne (Other)
Overall Status
Completed
CT.gov ID
NCT00861276
Collaborator
Pharmacia (Industry)
50
Enrollment
1
Location
2
Arms
18
Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nasal Spray Nicotine Substitute (Experimental)
  • Drug: Nasal Spray Nicotine Substitute (ad libitum)
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (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
Study Start Date :
Jun 1, 2000
Actual Primary Completion Date :
Jul 1, 2001
Actual Study Completion Date :
Dec 1, 2001

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

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 Names:
  • 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 Names:
  • Nicorette(R) Nasal Spray

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Ambulatory Care and Community Medicine Lausanne Vaud Switzerland 1011

    Sponsors and Collaborators

    • University of Lausanne
    • Pharmacia

    Investigators

    • Study Director: Jean-Pierre Zellweger, MD, Department of Ambulatory Care and Community Medicine, University of Lausanne

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00861276
    Other Study ID Numbers:
    • Prot 29/99
    First Posted:
    Mar 13, 2009
    Last Update Posted:
    Mar 13, 2009
    Last Verified:
    Mar 1, 2009
    Keywords provided by , ,
    Smoking Cessation
    Nicotine
    Administration and dosage
    Randomized Controlled Trial
    Additional relevant MeSH terms:
    Nicotine

    Study Results

    No Results Posted as of Mar 13, 2009