Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy

Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy. A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group, 52 Week Study in Smokers Motivated to Quit.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00882375

Enrollment

479

Registered

2009-04-16

Start date

2009-03-31

Completion date

2010-06-30

Last updated

2012-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

Smoking Cessation

Brief summary

A comparison of a novel nicotine replacement therapy and placebo treatment in smokers motivated to quit smoking.

Detailed description

Efficacy and safety study following use of a novel nicotine replacement therapy.

Interventions

DRUGNicotine

Nicotine administered using novel NRT user instructions

DRUGPlacebo

Placebo administered using novel NRT user instructions

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 years or older male and female cigarette smokers motivated and willing to stop smoking * Female participants of child-bearing potential should use a medically acceptable means of birth control. * Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate.

Exclusion criteria

* Unstable angina pectoris or myocardial infarction during the previous 3 months. * Pregnancy, lactation or intended pregnancy (non-pregnancy will be verified by urine pregnancy test for female participants of child-bearing potential). * Participation in other clinical trials within the previous three months and during study participation.

Design outcomes

Primary

Measure	Time frame
Self-reported continuous abstinence from smoking verified by exhaled CO levels of less than 10 ppm.	at weeks 2, 6, 24 and 52

Secondary

Measure	Time frame
Self-reported continuous abstinence from smoking, verified by exhaled CO levels of less than 10 ppm.	weeks 2, 4, 8, 12, 16, and 20
Self-reported 7-day point prevalence abstinence from smoking verified by exhaled CO levels of less than 10 ppm.	weeks 4, 6, 8, 12, 16, 20, 24, and 52
Ratings of craving/urge to smoke and withdrawal symptoms.	baseline to 24 weeks
Cotinine levels in saliva.	baseline, and weeks 2, 6, 12 and 24
Product acceptability	weeks 1, 6 and 12

Countries

Denmark, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026