SmokingPhase 2NCT01466361

Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving

A Phase 2 study testing Nicotine lower dose and Nicotine higher dose in people with Smoking and Smoking Cessation, run by GlaxoSmithKline at 1 site in United States.

Completed

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

Official record

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Trial summary

This study is designed to evaluate the ability of a nicotine lozenge to relieve craving for a cigarette compared to a matched placebo (a placebo is like sugar pill and contains no active). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Smoking, Smoking Cessation
What is being tested?: Nicotine lower dose and Nicotine higher dose
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 187 participants
Where: 1 siteUnited States
Study dates: Sep 2010to Dec 2010
Phase: Phase 2
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

Generally healthy smokers who smoke more than 5 cigarettes per day
Body mass index (BMI) within the range 19-35 kilogram (kg)/meter (m)^2
Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.

Who cannot join

Women who are pregnant or who have a positive urine pregnancy test.
Participants with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
Prior Concomitant Medication: Treatment with enzyme altering agents (e.g. carbamazepine, phenytoin, cimetidine, sodium valporate) within 30 days of the craving provocation visit; Use of any prescription psychoactive medication (such as but not limited to antidepressants, antipsychotics, anxiolytics) within 14 days of the craving provocation visit; Participant has used an over-the-counter (OTC) medication such as antihistamines, sedating agents, or any compound that would have a sedating effect within 24 hours of the craving provocation visit; Current use of any nicotine replacement therapy.
Substance abuse: Recent history or current history (within the last 1 year) of alcohol or other substance abuse.

Trial locations and contacts

1 site in 1 country.

United States1 site

Los Angeles Clinical Trials
Burbank, California, 91505

Other trials in United States

About this study

This study is designed to evaluate the ability of a nicotine lozenge to relieve craving for a cigarette compared to a matched placebo (a placebo is like sugar pill and contains no active).

Conditions: Smoking, Smoking Cessation
Being tested: Nicotine lower dose, Nicotine higher dose, Placebo
Keywords: Nicotine, Nicotine craving
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.

Nicotine lower doseDrug
lower dose nicotine lozenge
Nicotine higher doseDrug
higher dose nicotine lozenge
PlaceboDrug
placebo

Study groups in NCT01466361
Study group	Role	What they receive
Lower dose Nicotine	Active comparator	lower dose nicotine lozenge Receives: Drug: Nicotine lower dose
Higher dose Nicotine	Active comparator	higher dose Nicotine lozenge Receives: Drug: Nicotine higher dose
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

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

Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers
Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.
Measured: Baseline, 1, 3, 5, 10 and 15 minutes post-treatment
Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers
Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.
Measured: Baseline, 3 minutes and 15 minutes post-treatment

Secondary outcomes (2)

Percentage of Responders With Improved Craving Scores in Heavy and Light Smokers Group
Responders were defined as participants with an increase of at least one point (on the 100 point VAS scale) from baseline prior to provoked craving paradigm (B1) to baseline post provoked craving paradigm (B2) on the average cravings score. Percentage of these responders was calculated to evaluate the provocation rate.
Measured: Baseline prior to provoked craving paradigm, baseline post provoked craving paradigm
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with study treatment/s.
SAE was defined as any untoward medical occurrence that at any dose results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization results in disability/ incapacity; is a congenital anomaly/ birth defect.
Measured: Baseline, 0 minute, 60 minutes and 5 days post treatment

Timeline

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

Sep 2010Dec 2010

First posted7 Nov 2011 (estimated)
Study startSep 2010
Primary completionDec 2010
Study completionDec 2010

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 187 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01466361
Sponsor's protocol ID: S7120994
Status last verified: Aug 2019
First submitted: 3 Nov 2011
Last updated: 28 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

Nides M, Shanga GM, Bishop A, Becker WD. Nicotine Lozenges in the Relief of Behaviorally Provoked Craving. Am J Health Behav. 2018 May 1;42(3):69-80. doi: 10.5993/AJHB.42.3.7.
PubMed 29663982

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving
ClinicalTrials.gov ID: NCT01466361
Acronym / sponsor ID: S7120994
Conditions: Smoking, Smoking Cessation
Keywords: Nicotine, Nicotine craving
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 187 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 7 Nov 2011 (estimated)
Results: Posted 4 Dec 2012

Clinical summary

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

This study is designed to evaluate the ability of a nicotine lozenge to relieve craving for a cigarette compared to a matched placebo (a placebo is like sugar pill and contains no active).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Lower dose Nicotine	Active comparator	Drug: Nicotine lower doselower dose nicotine lozenge
Higher dose Nicotine	Active comparator	Drug: Nicotine higher dosehigher dose Nicotine lozenge
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

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

Key inclusion criteria (3 listed)

Generally healthy smokers who smoke more than 5 cigarettes per day
Body mass index (BMI) within the range 19-35 kilogram (kg)/meter (m)^2
Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.

Key exclusion criteria (5 listed)

Women who are pregnant or who have a positive urine pregnancy test.
Participants with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
Prior Concomitant Medication: Treatment with enzyme altering agents (e.g. carbamazepine, phenytoin, cimetidine, sodium valporate) within 30 days of the craving provocation visit; Use of any prescription psychoactive medication (such as but not limited to antidepressants, antipsychotics, anxiolytics) within 14 days of the craving provocation visit; Participant has used an over-the-counter (OTC) medication such as antihistamines, sedating agents, or any compound that would have a sedating effect within 24 hours of the craving provocation visit; Current use of any nicotine replacement therapy.
Substance abuse: Recent history or current history (within the last 1 year) of alcohol or other substance abuse.

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
Nicotine lower doselower dose nicotine lozenge	Drug	Lower dose Nicotine
Nicotine higher dosehigher dose nicotine lozenge	Drug	Higher dose Nicotine
Placeboplacebo	Drug	Placebo

Primary outcome

Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers
Time frame: Baseline, 1, 3, 5, 10 and 15 minutes post-treatment
Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.
Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers
Time frame: Baseline, 3 minutes and 15 minutes post-treatment
Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.

2 secondary outcomes

Percentage of Responders With Improved Craving Scores in Heavy and Light Smokers Group
Time frame: Baseline prior to provoked craving paradigm, baseline post provoked craving paradigm
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: Baseline, 0 minute, 60 minutes and 5 days post treatment

Results and safety

Results posted to the registry on 4 Dec 2012, 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 4 Milligrams (mg) (Heavy Smokers Group)	52	52
Placebo Lozenge (Heavy Smokers Group)	34	34
Nicotine Lozenge 1.5mg (Light Smokers Group)	60	60
Placebo Lozenge (Light Smokers Group)	41	41

Primary outcome: Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers

Time frame: Baseline, 1, 3, 5, 10 and 15 minutes post-treatment. Least squares mean (Standard Error). Unit: Score on a scale

Measure	Nicotine Lozenge 1.5mg (Light Smokers Group) n = 60	Placebo Lozenge 2 (Light Smokers Group) n = 41
1 minute	-15.40 (2.439)	-8.17 (2.958)
3 minutes	-24.42 (3.108)	-17.26 (3.770)
5 minutes	-30.19 (3.257)	-23.86 (3.950)
10 minutes	-35.33 (3.428)	-30.23 (4.158)
15 minutes	-38.99 (3.689)	-33.99 (4.475)

Nicotine Lozenge 1.5mg (Light Smokers Group) vs Placebo Lozenge 2 (Light Smokers Group): Least square mean difference: -7.23 (95% CI -14.89 to 0.44), p = 0.0643, ANCOVA
Nicotine Lozenge 1.5mg (Light Smokers Group) vs Placebo Lozenge 2 (Light Smokers Group): Least square mean difference: -7.16 (95% CI -16.93 to 2.61), p = 0.1489, ANCOVA
Nicotine Lozenge 1.5mg (Light Smokers Group) vs Placebo Lozenge 2 (Light Smokers Group): Least square mean difference: -6.33 (95% CI -16.56 to 3.90), p = 0.2225, ANCOVA

Population analysed: Intent to treat (ITT) population: All randomized participants with at least one cravings assessment measurement post dose were analyzed. No data was imputed in case of dropouts or missing data.

Primary outcome: Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers

Time frame: Baseline, 3 minutes and 15 minutes post-treatment. Least squares mean (Standard Error). Unit: Score on a scale

Measure	Nicotine Lozenge 4mg (Heavy Smokers Group) n = 52	Placebo Lozenge 1 (Heavy Smokers Group) n = 34
1 minute	-16.82 (2.613)	-13.24 (3.232)
3 minutes	-29.52 (3.124)	-19.82 (3.865)

Nicotine Lozenge 4mg (Heavy Smokers Group) vs Placebo Lozenge 1 (Heavy Smokers Group): Least square mean difference: -3.58 (95% CI -11.85 to 4.70), p = 0.3922, ANCOVA
Nicotine Lozenge 4mg (Heavy Smokers Group) vs Placebo Lozenge 1 (Heavy Smokers Group): Least square mean difference: -9.70 (95% CI -19.59 to 0.20), p = 0.0547, ANCOVA

Population analysed: ITT population: All randomized participants who had at least one cravings assessment measurement post dose.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nicotine Lozenge 1.5mg (Light Smokers Group)	0 of 60 (0%)	1 of 60 (1.7%)	Not reported
Nicotine Lozenge 4mg (Heavy Smokers Group)	0 of 52 (0%)	11 of 52 (21.2%)	Not reported
Placebo Lozenge 1 (Heavy Smokers Group)	0 of 34 (0%)	0 of 34 (0%)	Not reported
Placebo Lozenge 2 (Light Smokers Group)	0 of 41 (0%)	1 of 41 (2.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29663982Nides M, Shanga GM, Bishop A, Becker WD. Nicotine Lozenges in the Relief of Behaviorally Provoked Craving. Am J Health Behav. 2018 May 1;42(3):69-80. doi: 10.5993/AJHB.42.3.7.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nicotine lower dose and Nicotine higher dose in people with Smoking and Smoking Cessation, run by GlaxoSmithKline at 1 site in United States.

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 3 inclusion and 5 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 4 Dec 2012). 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?

Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers (time frame: Baseline, 1, 3, 5, 10 and 15 minutes post-treatment). The study lists 2 primary outcomes in all. 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 NCT01466361, 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 28 Aug 2019.