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Completed

NCT Number: NCT00985985

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

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.

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Key information

Conditions

Smoking Behavior Health Behavior Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nicotine

Drug

2 mg or 4 mg nicotine lozenge

Placebo

Drug

placebo lozenge

Primary outcomes

  1. Rate of Successful Smoking Cessation at Week 6

    Time frame: From baseline to Week 6

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

Secondary outcomes

  1. Rate of Continuous Successful Smoking Cessation at Week 12 and Week 24

    Time frame: From baseline to Week 12 and Week 24

    Continuous abstinence was verified by measurement of CO breath levels.

  2. Rate of Long-term Successful Smoking Cessation at Week 24

    Time frame: From Week 6 to Week 24

    Rate of long-term successful smoking cessation at Week 24 was defined as the proportion of participants who achieved the primary end-point with no more than six cumulative days of smoking from Week 6 to Week 24.

  3. Proportion of Participants With Seven Day Point Prevalence Abstinence

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

    Seven day point prevalence abstinence was defined as complete abstinence from smoking for the 7 days up to and including the evaluation day.

  4. Mean Score of Relief of Craving/ Total Withdrawal Symptoms

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

    The evaluation of withdrawal and craving symptoms was carried out every day with the Minnesota Nicotine Withdrawal scale (MNWS). The MNWS total score contains 9 items (urge to smoke; depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating; restlessness; increased appetite; difficulty going to sleep; difficulty staying asleep). Each item was rated on a 5 grade scale with scores ranging from 0 (best score) to 4 (worst score) i.e. none (score=0), slight (score=1), mild (score=2), moderate (score=3), and severe (score=4). For each symptom at each week, the average score was calculated as the average of the daily scores during that week. The total score was calculated as the sum of the 9 symptoms.

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

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

    Mean daily dose of lozenges was calculated as number of lozenges taken at each visit divided by days since the last visit.

  6. Mean Change From Baseline in Body Weight at Week 6, Week 12 and Week 24/ Premature Termination.

    Time frame: Baseline, Week 6, 12 and Week 24

    Change in body weight was analyzed at Weeks 6, 12, and 24.

  7. Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Cardiovascular AEs and Who Discontinued Due to AEs

    Time frame: Weekly assessments from first treatment dose up to 15 days after last treatment dose

    All AEs and SAEs were reviewed and reported by investigator. AEs were graded on a 3-point scale as Mild, Moderate and Severe.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 29, 2009
Registry last updated
Jun 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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