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OpenTrials
Completed

NCT Number: NCT00861276

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

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Ambulatory Care and Community Medicine

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasal Spray Nicotine Substitute (Experimental)

Drug

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

Nasal Spray Nicotine Substitute (ad libitum)

Drug

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

Primary outcomes

  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).

    Time frame: first 3 weeks

Secondary outcomes

  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)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Lausanne

Other

Collaborators

  • Pharmacia

Registry information

Official study title

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

Acronym: SUNIC

Important dates

Study start
2000
Primary completion
2001
Study completion
2001
First posted
Mar 13, 2009
Registry last updated
Mar 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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