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

This study has been completed.
Sponsor:
Collaborator:
Pharmacia
Information provided by:
University of Lausanne
ClinicalTrials.gov Identifier:
NCT00861276
First received: March 12, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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 Intervention Phase
Smoking Cessation
Drug: Nasal Spray Nicotine Substitute (Experimental)
Drug: Nasal Spray Nicotine Substitute (ad libitum)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by University of Lausanne:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: June 2000
Study Completion Date: December 2001
Primary Completion Date: July 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861276

Locations
Switzerland
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
  More Information

Additional Information:
No publications provided by University of Lausanne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alain Pecoud, Department of Ambulatory Care and Community Medicine, University of Lausanne
ClinicalTrials.gov Identifier: NCT00861276     History of Changes
Other Study ID Numbers: Prot 29/99
Study First Received: March 12, 2009
Last Updated: March 12, 2009
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Lausanne:
Smoking Cessation
Nicotine
Administration and dosage
Randomized Controlled Trial

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014