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

NCT00985985 | Completed Phase 3 Results

• 1 other identifier: CHN-Nicotine Mint Lozenge-002
• Study Type: interventional
• Target: 723
• Locations: 0 countries
• Sites: N/A

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

Keywords

smoking cessation; nicotine lozenge; nicotine replacement therapy

Outcome Measures

Primary Outcomes (1)

• Rate of Successful Smoking Cessation at Week 6

  Rate of Successful Smoking Cessation at Week 6 was measured by Carbon Monoxide (CO) breath levels.

  From baseline to Week 6

Secondary Outcomes (7)

• Rate of Continuous Successful Smoking Cessation at Week 12 and Week 24

  From baseline to Week 12 and Week 24

• Rate of Long-term Successful Smoking Cessation at Week 24

  From Week 6 to Week 24

• Proportion of Participants With Seven Day Point Prevalence Abstinence

  Weekly assessment at Week 1, 2, 4, 6, 12 and Week 24

• Mean Score of Relief of Craving/ Total Withdrawal Symptoms

  Weekly assessment at Week 1, 2, 3, 4, 5 and Week 6

• Mean Daily Dose at Visit 4, 5, 6, 7 and 10

  Weeks 1-2, 3-4, 5-6, 7-12 and 13-24

Study Arms (4)

2mg nicotine lozenge

EXPERIMENTAL

2 mg nicotine lozenge

Drug: Nicotine

2 mg placebo

PLACEBO COMPARATOR

2 mg placebo

Drug: Placebo

4 mg nicotine lozenge

EXPERIMENTAL

4 mg nicotine lozenge

Drug: Nicotine

4 mg placebo

PLACEBO COMPARATOR

4 mg placebo

Drug: Placebo

Interventions

Nicotine DRUG

2 mg or 4 mg nicotine lozenge

2mg nicotine lozenge; 4 mg nicotine lozenge

Placebo DRUG

placebo lozenge

2 mg placebo; 4 mg placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• 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.

  PMID: 34611902 DERIVED

MeSH Terms

Conditions

Smoking; Smoking Cessation

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2009
• First Posted: September 29, 2009
• Study Start: May 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: June 27, 2014
• Results First Posted: June 16, 2014

Record last verified: 2014-06