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

NCT00861276 | Completed Phase 4

• 1 other identifier: Prot 29/99
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

Smoking Cessation; Nicotine; Administration and dosage; Randomized Controlled Trial

Outcome Measures

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).

  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)

  6 months

Study Arms (2)

1

EXPERIMENTAL

Arm instructed to use spray at least once an hour when awake.

Drug: Nasal Spray Nicotine Substitute (Experimental)

2

ACTIVE COMPARATOR

Ad libitum: patients were instructed to use NNS when craving appears.

Drug: Nasal Spray Nicotine Substitute (ad libitum)

Interventions

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).

Also known as: Nicorette(R) nasal spray

1

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.

Also known as: Nicorette(R) Nasal Spray

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Highly dependent smokers in the stage of preparation according to Prochaska and Di Clemente's stages of change model

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lausanne: lead
• Pharmacia: collaborator

Study Sites (1)

Department of Ambulatory Care and Community Medicine

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (2)

• Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.

  PMID: 37335995 DERIVED

• Rey L, Vaucher P, Secretan F, Zellweger JP, Bodenmann P. Use of nicotine substitute prescribed at hourly plus ab libitum intake or ad libitum for heavy smokers willing to quit: a randomized controlled trial. Subst Abuse Treat Prev Policy. 2009 Jun 2;4:12. doi: 10.1186/1747-597X-4-12.

  PMID: 19490626 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nasal Sprays

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Jean-Pierre Zellweger, MD

  Department of Ambulatory Care and Community Medicine, University of Lausanne

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 13, 2009
• Study Start: June 1, 2000
• Primary Completion: July 1, 2001
• Study Completion: December 1, 2001
• Last Updated: March 13, 2009

Record last verified: 2009-03

Locations

CH (1)