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

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-006845-13-DK

Enrollment

465

Registered

2008-11-24

Start date

2009-02-02

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

For the treatment of tobacco dependence by relieving nicotine craving and withdrawal symptoms, thereby facilitating smoking cessation in smokers motivated to quit abruptly. MedDRA version: 9.1 Level: LLT Classification code 10008374 Term: Cessation of smoking MedDRA version: 9.1 Level: LLT Classification code 10053325 Term: Smoking cessation therapy MedDRA version: 9.1 Level: LLT Classification code 10059612 Term: Tobacco withdrawal symptoms

Interventions

Product Name: Nicotine Mouth Spray and/or Oromucosal Nicotine Spray Product Code: NMS and/or ONS Pharmaceutical Form: Oromucosal spray CAS Number: 54115 Other descriptive name: Nicotine Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. males and females 18 years or older, 2. daily cigarette smoker for the last three years or more, 3. CO level of at least 10 ppm after at least 15 smoke-free minutes, 4. motivated and willing to completely stop smoking from the day after the baseline visit and to stay smokefree. 5. willing to use NMS for at least 12 weeks, 6. female participants of child-bearing potential should have used a medically acceptable means of birth control for at least one month prior to the baseline visit and continue to use birth control during the study period and for one month after the last dose of study drug, 7. 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, 8. be willing and able to comply with all study procedures and attend the 11 scheduled visits for the 52 weeks duration of the study, 9. be willing and able to use an eDiary according to the provided instructions and willing to return the eDiary at the 12-week visit Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. current use of tobacco-containing products, other than cigarettes (e.g., snuff/snus, chewing tobacco, cigars, or pipe), or smoking of other substances, 2. use of other NRT, bupropion, or varenicline, or undergoing any treatment for tobacco dependence (e.g. acupuncture), during the previous 6 months, 3. unstable angina pectoris or myocardial infarction or stroke during the previous 3 months, 4. pregnancy, lactation or intended pregnancy (non-pregnancy will be verified by urine pregnancy test for female participants of child-bearing potential), 5. suspected alcohol or drug abuse, 6. have a member of the same household who is also a subject in the current study, 7. participation in other clinical trials within the previous 3 months and during study participation, 8. an acute or chronic medical or psychiatric condition or previously diagnosed clinically important renal or hepatic disease, that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 9. subjects with presence of an oral lesion (suspected malignant lesion and/or erosive lesion), requiring further investigation such as biopsy.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of NMS versus placebo in smokers to achieve continuous abstinence from smoking from the week 2 visit until and including the week 6, week 24, and week 52 visits, respectively. ;Secondary Objective: To evaluate the efficacy of NMS versus placebo in smokers to achieve continuous abstinence from smoking from the week 2 visit through all other time points throughout the study (i.e. until and including the week 4, 8, 12, 16, and 20 visits, respectively), To evaluate the efficacy of NMS versus placebo in smokers on 7-day point prevalence abstinence from smoking at week 4 and all remaining visits, To assess the efficacy of NMS versus placebo in smokers on craving and withdrawal symptoms during the initial four weeks on study (daily ratings), as well as point ratings at weeks 4, 6, 8, 12, 16, 20 and 24, To document the compliance of NMS, To assess the level of nicotine substitution by measuring saliva cotinine levels, To document smoking status throughout the study, To evaluate the safety and adverse event profile of NMS, including vital signs, To evaluate the product acceptability of NMS. ;Primary end point(s): self-reported continuous abstinence from smoking from the week 2 visit until and including the week 6, week 24 and week 52 visits, respectively, verified by an exhaled carbon monoxide (CO) level of less than 10 ppm at all clinic visits from week 2 until and including weeks 6, 24 and 52, respectively. Missing CO measurements at weeks 8, 16 and/or 20 will not disqualify success if subject claims continuous abstinence from smoking, verified by an exhaled CO level of less than 10 ppm at later visits. Thus, to be classified as a treatment success: - after 6 weeks a subject will have to report no smoking between weeks 2 and 6 and to present a CO level of less than 10 ppm at visits weeks 2, 4 and 6, respectively. Subjects who report use of other-than-study NRT, varenicline or bupropion for smoking cessation anytime between weeks	—

Measure

Time frame

Main Objective: To evaluate the efficacy of NMS versus placebo in smokers to achieve continuous abstinence from smoking from the week 2 visit until and including the week 6, week 24, and week 52 visits, respectively. ;Secondary Objective: To evaluate the efficacy of NMS versus placebo in smokers to achieve continuous abstinence from smoking from the week 2 visit through all other time points throughout the study (i.e. until and including the week 4, 8, 12, 16, and 20 visits, respectively), To evaluate the efficacy of NMS versus placebo in smokers on 7-day point prevalence abstinence from smoking at week 4 and all remaining visits, To assess the efficacy of NMS versus placebo in smokers on craving and withdrawal symptoms during the initial four weeks on study (daily ratings), as well as point ratings at weeks 4, 6, 8, 12, 16, 20 and 24, To document the compliance of NMS, To assess the level of nicotine substitution by measuring saliva cotinine levels, To document smoking status throughout the study, To evaluate the safety and adverse event profile of NMS, including vital signs, To evaluate the product acceptability of NMS. ;Primary end point(s): self-reported continuous abstinence from smoking from the week 2 visit until and including the week 6, week 24 and week 52 visits, respectively, verified by an exhaled carbon monoxide (CO) level of less than 10 ppm at all clinic visits from week 2 until and including weeks 6, 24 and 52, respectively. Missing CO measurements at weeks 8, 16 and/or 20 will not disqualify success if subject claims continuous abstinence from smoking, verified by an exhaled CO level of less than 10 ppm at later visits. Thus, to be classified as a treatment success: - after 6 weeks a subject will have to report no smoking between weeks 2 and 6 and to present a CO level of less than 10 ppm at visits weeks 2, 4 and 6, respectively. Subjects who report use of other-than-study NRT, varenicline or bupropion for smoking cessation anytime between weeks

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Countries

Denmark, Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026