SmokingPhase 3NCT00985985

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

A Phase 3 study testing Nicotine in people with Smoking, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Smoking
What is being tested?: Nicotine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 723 participants
Where: No sites listed yet
Study dates: May 2009to Mar 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 16Show fewer

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.

About this study

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

Conditions: Smoking
Being tested: Nicotine, Placebo
Keywords: smoking cessation, nicotine lozenge, nicotine replacement therapy
Medical subject headings: Smoking, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NicotineDrug
2 mg or 4 mg nicotine lozenge
PlaceboDrug
placebo lozenge

Study groups in NCT00985985
Study group	Role	What they receive
2mg nicotine lozenge	Experimental	2 mg nicotine lozenge Receives: Drug: Nicotine
2 mg placebo	Placebo comparator	2 mg placebo Receives: Drug: Placebo
4 mg nicotine lozenge	Experimental	4 mg nicotine lozenge Receives: Drug: Nicotine
4 mg placebo	Placebo comparator	4 mg placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of Successful Smoking Cessation at Week 6
Rate of Successful Smoking Cessation at Week 6 was measured by Carbon Monoxide (CO) breath levels.
Measured: From baseline to Week 6

Secondary outcomes (7)

Rate of Continuous Successful Smoking Cessation at Week 12 and Week 24
Continuous abstinence was verified by measurement of CO breath levels.
Measured: From baseline to Week 12 and Week 24
Rate of Long-term Successful Smoking Cessation at 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.
Measured: From Week 6 to Week 24
Proportion of Participants With Seven Day Point Prevalence Abstinence
Seven day point prevalence abstinence was defined as complete abstinence from smoking for the 7 days up to and including the evaluation day.
Measured: Weekly assessment at Week 1, 2, 4, 6, 12 and Week 24
Mean Score of Relief of Craving/ Total Withdrawal Symptoms
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.
Measured: Weekly assessment at Week 1, 2, 3, 4, 5 and Week 6
Mean Daily Dose at Visit 4, 5, 6, 7 and 10
Mean daily dose of lozenges was calculated as number of lozenges taken at each visit divided by days since the last visit.
Measured: Weeks 1-2, 3-4, 5-6, 7-12 and 13-24
Mean Change From Baseline in Body Weight at Week 6, Week 12 and Week 24/ Premature Termination.
Change in body weight was analyzed at Weeks 6, 12, and 24.
Measured: Baseline, Week 6, 12 and Week 24
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Cardiovascular AEs and Who Discontinued Due to AEs
All AEs and SAEs were reviewed and reported by investigator. AEs were graded on a 3-point scale as Mild, Moderate and Severe.
Measured: Weekly assessments from first treatment dose up to 15 days after last treatment dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Mar 2011

First posted29 Sep 2009 (estimated)
Study startMay 2009
Primary completionMar 2011
Study completionMar 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SmokingStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 723 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00985985
Sponsor's protocol ID: CHN-Nicotine Mint Lozenge-002
Status last verified: Jun 2014
First submitted: 2 Sep 2009
Last updated: 27 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 34611902

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation

All Smoking trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00985985
Acronym / sponsor ID: CHN-Nicotine Mint Lozenge-002
Conditions: Smoking
Keywords: smoking cessation, nicotine lozenge, nicotine replacement therapy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 723 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: May 2009
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 29 Sep 2009 (estimated)
Results: Posted 16 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
2mg nicotine lozenge	Experimental	Drug: Nicotine2 mg nicotine lozenge
2 mg placebo	Placebo comparator	Drug: Placebo2 mg placebo
4 mg nicotine lozenge	Experimental	Drug: Nicotine4 mg nicotine lozenge
4 mg placebo	Placebo comparator	Drug: Placebo4 mg placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (16 listed)

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.;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nicotine2 mg or 4 mg nicotine lozenge	Drug	2mg nicotine lozenge, 4 mg nicotine lozenge
Placeboplacebo lozenge	Drug	2 mg placebo, 4 mg placebo

Primary outcome

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.

7 secondary outcomes

Rate of Continuous Successful Smoking Cessation at Week 12 and Week 24
Time frame: From baseline to Week 12 and Week 24
Rate of Long-term Successful Smoking Cessation at Week 24
Time frame: From Week 6 to Week 24
Proportion of Participants With Seven Day Point Prevalence Abstinence
Time frame: Weekly assessment at Week 1, 2, 4, 6, 12 and Week 24
Mean Score of Relief of Craving/ Total Withdrawal Symptoms
Time frame: Weekly assessment at Week 1, 2, 3, 4, 5 and Week 6
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 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
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

Results and safety

Results posted to the registry on 16 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nicotine Lozenge 2 Milligram (mg) (Low Dependence Smokers)	241	217
Placebo Lozenge (Low Dependence Smokers)	242	218
Nicotine Lozenge 4 mg (High Dependence Smokers)	120	109
Placebo Lozenge (High Dependence Smoke	120	107

Primary outcome: Rate of Successful Smoking Cessation at Week 6

Time frame: From baseline to Week 6. Number. Unit: Percentage of participants

Measure	Nicotine Lozenge 2 mg (Low Dependence Smokers) n = 241	Placebo Lozenge (Low Dependence Smokers) n = 242	Nicotine Lozenge 4 mg (High Dependence Smokers) n = 120	Placebo Lozenge (High Dependence Smokers) n = 119
Value	24.48	21.49	30.83	20.17

Nicotine Lozenge 2 mg (Low Dependence Smokers) vs Placebo Lozenge (Low Dependence Smokers): Odds Ratio (OR): 1.22 (95% CI 0.78 to 1.92), p = 0.3851, Cochran-Mantel-Haenszel
Nicotine Lozenge 4 mg (High Dependence Smokers) vs Placebo Lozenge (High Dependence Smokers): Odds Ratio (OR): 1.82 (95% CI 0.99 to 3.32), p = 0.0565, Cochran-Mantel-Haenszel

Population analysed: Analysis was considered per Full Analysis Set (FAS) population. FAS population consisted of all randomized participants who had study medication for at least once with assessment data post-dosing.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nicotine Lozenge 2 mg (Low Dependence Smokers)	1 of 241 (0.4%)	59 of 241 (24.5%)	Not reported
Placebo Lozenge (Low Dependence Smokers)	0 of 242 (0%)	45 of 242 (18.6%)	Not reported
Nicotine Lozenge 4 mg (High Dependence Smokers)	1 of 119 (0.8%)	43 of 119 (36.1%)	Not reported
Placebo Lozenge (High Dependence Smokers)	1 of 118 (0.8%)	26 of 118 (22%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34611902Hartmann-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.

Related trials for Smoking

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PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nicotine in people with Smoking, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Successful Smoking Cessation at Week 6 (time frame: From baseline to Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00985985, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2014.