Smoking DependencePhase 2NCT01506908

Provoked Craving Assessment

A Phase 2 study testing oral nicotine in people with Smoking Dependence and Smoking, 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

Evaluation of the ability of a nicotine mini lozenge to provide early relief of craving for a cigarette in smokers Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Smoking Dependence, Smoking
What is being tested?: oral nicotine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 323 participants
Where: 1 siteUnited States
Study dates: Sep 2011to Dec 2011
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Current cigarette smokers who have smoked regularly, and smoke more than 20 cigarettes per day on a regular basis for at least a year;
Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history.

Who cannot join

Any disease that may interfere with the absorption, metabolism or excretion of the study product.
A medical condition that might jeopardise the safety of the subject or the validity of the study results. For example, recent myocardial infarction or cerebrovascular incident (within 12 weeks of the screening visit), phenylketonuria, unstable or worsening angina pectoris, Prinzmetals angina or severe cardiac arrhythmia

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

Official title: Evaluation of the Nicotine Mini Lozenge in Relief of Provoked Acute Craving

Evaluation of the ability of a nicotine mini lozenge to provide early relief of craving for a cigarette in smokers

Conditions: Smoking Dependence, Smoking
Being tested: oral nicotine, Placebo
Keywords: craving
Medical subject headings: Smoking

What participants receive

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

oral nicotineDrug
oral nicotine replacement product
PlaceboDrug
no active

Study groups in NCT01506908
Study group	Role	What they receive
Nicotine Polacrilex mint mini lozenge	Active comparator	Not described Receives: Drug: oral nicotine
placebo	Placebo comparator	mint mini lozenge with no active Receives: Drug: Placebo

What is being measured

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

Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes
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 was measured.
Measured: Post-cue baseline,5 minutes

Secondary outcomes (5)

Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute
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 was measured.
Measured: Post-cue baseline, 1 minute post treatment administration
Change From Post-cue Baseline in Nicotine Craving Score at 3 Minutes
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 was measured.
Measured: Post-cue Baseline, 3 minutes post treatment administration
Change From Post-cue Baseline in Nicotine Craving Score at 7 Minutes
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 was measured.
Measured: Post-Cue Baseline, 7 minutes post treatment administration
Change From Post-cue Baseline in Nicotine Craving Score at 10 Minutes
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 was measured.
Measured: Post-Cue Baseline, 10 minutes post treatment administration
Number of Participants With Adverse Events (AEs), Treatment Related 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. Treatment related AE was defined as any AE considered to be possibly, probably or highly probably related to study medication. 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 to Day 5 post treatment administration

Timeline

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

Sep 2011Dec 2011

First posted10 Jan 2012 (estimated)
Study startSep 2011
Primary completionDec 2011
Study completionDec 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 Smoking DependenceStudies 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: 323 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01506908
Sponsor's protocol ID: S7121359
Status last verified: Aug 2019
First submitted: 15 Dec 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?

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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 Mini Lozenge in Relief of Provoked Acute Craving
ClinicalTrials.gov ID: NCT01506908
Acronym / sponsor ID: S7121359
Conditions: Smoking Dependence, Smoking
Keywords: craving
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 323 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 10 Jan 2012 (estimated)
Results: Posted 30 Jan 2014

Clinical summary

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

Evaluation of the ability of a nicotine mini lozenge to provide early relief of craving for a cigarette in smokers

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Nicotine Polacrilex mint mini lozenge	Active comparator	Drug: oral nicotine
placebo	Placebo comparator	Drug: Placebomint mini lozenge with no active

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Current cigarette smokers who have smoked regularly, and smoke more than 20 cigarettes per day on a regular basis for at least a year;
Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history.

Key exclusion criteria (2 listed)

Any disease that may interfere with the absorption, metabolism or excretion of the study product.
A medical condition that might jeopardise the safety of the subject or the validity of the study results. For example, recent myocardial infarction or cerebrovascular incident (within 12 weeks of the screening visit), phenylketonuria, unstable or worsening angina pectoris, Prinzmetals angina or severe cardiac arrhythmia

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
oral nicotineoral nicotine replacement product	Drug	Nicotine Polacrilex mint mini lozenge
Placebono active	Drug	placebo

Primary outcome

Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes
Time frame: Post-cue baseline,5 minutes
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 was measured.

5 secondary outcomes

Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute
Time frame: Post-cue baseline, 1 minute post treatment administration
Change From Post-cue Baseline in Nicotine Craving Score at 3 Minutes
Time frame: Post-cue Baseline, 3 minutes post treatment administration
Change From Post-cue Baseline in Nicotine Craving Score at 7 Minutes
Time frame: Post-Cue Baseline, 7 minutes post treatment administration
Change From Post-cue Baseline in Nicotine Craving Score at 10 Minutes
Time frame: Post-Cue Baseline, 10 minutes post treatment administration
Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs)
Time frame: Baseline to Day 5 post treatment administration

Results and safety

Results posted to the registry on 30 Jan 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 4 Milligrams (mg)	162	161
Matched Placebo	161	161

Primary outcome: Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes

Time frame: Post-cue baseline,5 minutes. Least squares mean (95% Confidence Interval). Unit: Score on a scale

Measure	Nicotine Lozenge 4 mg n = 162	Matched Placebo n = 161
Value	-41.8 (-45.8 to -37.7)	-25.9 (-30.0 to -21.8)

Nicotine Lozenge 4 mg vs Matched Placebo: Least squares means difference: -15.9 (95% CI -21.6 to -10.2), p <0.0001, ANCOVA

Population analysed: Intention to Treat (ITT) population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on last observation carried forward (LOCF) technique.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nicotine Lozenge 4 mg	0 of 162 (0%)	54 of 162 (33.3%)	Not reported
Placebo Lozenge	0 of 161 (0%)	12 of 161 (7.5%)	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 oral nicotine in people with Smoking Dependence and Smoking, 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 2 inclusion and 2 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 30 Jan 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?

Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes (time frame: Post-cue baseline,5 minutes). 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 NCT01506908, 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; AzTrials last refreshed its copy on 27 Oct 2026.