Efficacy and Safety Study of Nicotine Mint Lozenge (2mg and 4mg) in Smoking Cessation

NCT ID: NCT00985985

Last Updated: 2014-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 723 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-03-31

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.

Conditions

Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

2mg nicotine lozenge

2 mg nicotine lozenge

Group Type: EXPERIMENTAL

Nicotine

Intervention Type: DRUG

2 mg or 4 mg nicotine lozenge

2 mg placebo

2 mg placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo lozenge

4 mg nicotine lozenge

4 mg nicotine lozenge

Group Type: EXPERIMENTAL

Nicotine

Intervention Type: DRUG

2 mg or 4 mg nicotine lozenge

4 mg placebo

4 mg placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo lozenge

Interventions

Nicotine

2 mg or 4 mg nicotine lozenge

Intervention Type: DRUG

Placebo

placebo lozenge

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

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.

Reference Type: DERIVED

PMID: 34611902 (View on PubMed)

Other Identifiers

CHN-Nicotine Mint Lozenge-002

Identifier Type: -

Identifier Source: org_study_id