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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-06-30

Study Completion Date

2001-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nicotine Replacement and Counseling In Adolescents

NCT00625794

Smoking Cessation

COMPLETED PHASE4

Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy

NCT00882375

Smoking Cessation

COMPLETED NA

Pilot Study of a New Nicotine Replacement Therapy

NCT00764439

Smoking Cessation

COMPLETED PHASE2

Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy

NCT02355665

Tobacco Dependence

COMPLETED PHASE3

Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Therapy and Nicotine Gum

NCT01368016

Tobacco Dependence

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Cessation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

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

Group Type EXPERIMENTAL

Nasal Spray Nicotine Substitute (Experimental)

Intervention Type 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).

2

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

Group Type ACTIVE_COMPARATOR

Nasal Spray Nicotine Substitute (ad libitum)

Intervention Type DRUG

In the control group, participants were instructed to use NNS as needed to suppress withdrawal symptoms when cravings appeared.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Nicorette(R) nasal spray Nicorette(R) Nasal Spray

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes