Clinical trial NCT00985985: Efficacy and Safety Study of Nicotine Mint Lozenge (2mg and 4mg) in Smoking Cessation
Official title: A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Clinical Study to Evaluate Efficacy and Safety of Nicotine Mint Lozenge (2mg and 4mg) in Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking
Keywords: smoking cessation
nicotine lozenge
nicotine replacement therapy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-09-29
Enrollment: 723
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multi-center, randomized, double-blind, placebo-controlled, 4-arm clinical study to evaluate efficacy and safety of nicotine lozenge (2mg and 4mg) in smoking cessation in adult cigarette smokers who are motivated to quit smoking. Successful quitters or participants who smoke occasionally will be followed up after week 24 till 12 months.


Eligibility criteria: Inclusion Criteria:

* Participant must be 18 years of age or older;
* Participant is motivated in smoking cessation using nicotine mint lozenge;
* Participant has the habit of smoking regularly every day for at least 1 year;
* Participant is able to read and provide written informed consent.

Exclusion Criteria:

* Participant uses other forms of tobacco other than cigarettes such as pipes, cigars, snuff, or smokeless tobacco within 30 days of entry into the study;
* Participant uses other nicotine delivery system such as nicotine gum, nicotine patch, nicotine inhaler, or nicotine nasal spray etc. within 30 days of study entry;
* Participant smoke any other substance within 30 days of study entry (such as cannabis, cocaine, heroin, ice drug, herbal cigarettes etc);
* The participant has a past history of alcohol or drug abuse;
* Participants use other smoking cessation aids (including bupropion, varenicline, traditional Chinese medicines such as herbals, acupuncture, consultation etc), within 30 days of study entry.;
* Participant is currently involved in another clinical trial or has used any investigational medication within 30 days of study entry; Any previous participation in this study;
* Participant is a member of the same household as another clinical subject. Subject is a relative of study site staff or member of the study staff;
* Participant is pregnant or breast-feeding, or has childbearing potential but refusing taking medical contraception measures (within first 24 weeks during study). (Note: All female subjects with childbearing potential must take urine pregnancy test before entry the study, only negative result subject is permitted to this study.);
* Participants who have heart and cerebral vascular disease not stable or controlled by medication or have an irregular heartbeat or have had a heart attack within the last 3 months;
* Participants with poorly controlled high blood pressure by medications, systolic BP greater than or equal to 140mmHg, diastolic BP greater than or equal to 90mmHg after administration;
* Participants having hyperthyroidism or current application of insulin for diabetes;
* Participants having myocardial infarction or cerebral vascular accidents recently (within the past 3 months);
* Participants who are unable to fulfill study requirements in relation to conforming to the visit schedule;
* Participants who are allergy to Aspartame or Phenylpyruvic acid (an edulcorant is widely used in foods and drinks)，or have diagnosed with Phenylketonuria;
* The other clinically significant pulmonary, gastrointestinal, liver, neurological, renal or haematological abnormalities.( unstable or worsening angina pectoris, Prinzmetal's angina, nerve or circulatory problems, rheumatoid arthritis, moderate and severe COPD);
* A medical history that, in the opinion of the investigator, might jeopardize the safety of the subject or the validity for the study results.

Primary outcomes:
measure: Rate of Successful Smoking Cessation at Week 6
timeFrame: From baseline to Week 6
Secondary outcomes:
measure: Rate of Continuous Successful Smoking Cessation at Week 12 and Week 24
timeFrame: From baseline to Week 12 and Week 24
measure: Rate of Long-term Successful Smoking Cessation at Week 24
timeFrame: From Week 6 to Week 24
measure: Proportion of Participants With Seven Day Point Prevalence Abstinence
timeFrame: Weekly assessment at Week 1, 2, 4, 6, 12 and Week 24
measure: Mean Score of Relief of Craving/ Total Withdrawal Symptoms
timeFrame: Weekly assessment at Week 1, 2, 3, 4, 5 and Week 6
measure: Mean Daily Dose at Visit 4, 5, 6, 7 and 10
timeFrame: Weeks 1-2, 3-4, 5-6, 7-12 and 13-24
measure: Mean Change From Baseline in Body Weight at Week 6, Week 12 and Week 24/ Premature Termination.
timeFrame: Baseline, Week 6, 12 and Week 24
measure: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Cardiovascular AEs and Who Discontinued Due to AEs
timeFrame: Weekly assessments from first treatment dose up to 15 days after last treatment dose
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.