Trial Outcomes & Findings for Provoked Craving Assessment (NCT NCT01506908)

Last Updated: 2019-08-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

323 participants

Primary outcome timeframe

Post-cue baseline,5 minutes

Results posted on

2019-08-28

Participant Flow

Participants were recruited at the clinical site.

Of 423 screened participants, 323 were randomized while 94 did not meet the study criterion and remaining 6 discontinued due to other reasons. All randomized participants had a history of smoking more than 20 cigarettes per day.

Participant milestones

Participant milestones
Measure	Nicotine Lozenge 4 Milligrams (mg) Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.	Matched Placebo Participants received a single dose of matched placebo mint lozenge, through oral route.
Overall Study STARTED	162	161
Overall Study COMPLETED	161	161
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Nicotine Lozenge 4 Milligrams (mg) Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.	Matched Placebo Participants received a single dose of matched placebo mint lozenge, through oral route.
Overall Study Adverse Event	1	0

Baseline Characteristics

Provoked Craving Assessment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nicotine Lozenge 4 mg n=162 Participants Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.	Matched Placebo n=161 Participants Participants received a single dose of matched placebo mint lozenge, through oral route.	Total n=323 Participants Total of all reporting groups
Sex: Female, Male Male	87 Participants n=5 Participants	87 Participants n=7 Participants	174 Participants n=5 Participants
Body Mass Index	27.79 Kilograms (kg)/ meter (m)^2 STANDARD_DEVIATION 3.73 • n=5 Participants	27.56 Kilograms (kg)/ meter (m)^2 STANDARD_DEVIATION 4.05 • n=7 Participants	27.67 Kilograms (kg)/ meter (m)^2 STANDARD_DEVIATION 3.89 • n=5 Participants
Age, Continuous	43.69 Years STANDARD_DEVIATION 12.13 • n=5 Participants	44.45 Years STANDARD_DEVIATION 11.64 • n=7 Participants	44.07 Years STANDARD_DEVIATION 11.88 • n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	74 Participants n=7 Participants	149 Participants n=5 Participants

PRIMARY outcome

Timeframe: Post-cue baseline,5 minutes

Population: 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.

Outcome measures

Outcome measures
Measure	Nicotine Lozenge 4 mg n=162 Participants Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.	Matched Placebo n=161 Participants Participants received a single dose of matched placebo mint lozenge, through oral route.
Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes	-41.8 Score on a scale Interval -45.8 to -37.7	-25.9 Score on a scale Interval -30.0 to -21.8

SECONDARY outcome

Timeframe: Post-cue baseline, 1 minute post treatment administration

Population: ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique.

Outcome measures

Outcome measures
Measure	Nicotine Lozenge 4 mg n=162 Participants Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.	Matched Placebo n=161 Participants Participants received a single dose of matched placebo mint lozenge, through oral route.
Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute	-17.2 Score on a scale Interval -20.1 to -14.2	-12.9 Score on a scale Interval -15.9 to -10.0

SECONDARY outcome

Timeframe: Post-cue Baseline, 3 minutes post treatment administration

Population: ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique.

Outcome measures

Outcome measures
Measure	Nicotine Lozenge 4 mg n=162 Participants Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.	Matched Placebo n=161 Participants Participants received a single dose of matched placebo mint lozenge, through oral route.
Change From Post-cue Baseline in Nicotine Craving Score at 3 Minutes	-31.1 Score on a scale Interval -34.8 to -27.5	-19.6 Score on a scale Interval -23.2 to -15.9

SECONDARY outcome

Timeframe: Post-Cue Baseline, 7 minutes post treatment administration

Population: ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique.

Outcome measures

Outcome measures
Measure	Nicotine Lozenge 4 mg n=162 Participants Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.	Matched Placebo n=161 Participants Participants received a single dose of matched placebo mint lozenge, through oral route.
Change From Post-cue Baseline in Nicotine Craving Score at 7 Minutes	-48.2 Score on a scale Interval -52.5 to -43.9	-30.5 Score on a scale Interval -34.8 to -26.2

SECONDARY outcome

Timeframe: Post-Cue Baseline, 10 minutes post treatment administration

Population: ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique

Outcome measures

Outcome measures
Measure	Nicotine Lozenge 4 mg n=162 Participants Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.	Matched Placebo n=161 Participants Participants received a single dose of matched placebo mint lozenge, through oral route.
Change From Post-cue Baseline in Nicotine Craving Score at 10 Minutes	-50.8 Score on a scale Interval -55.3 to -46.2	-32.9 Score on a scale Interval -37.5 to -28.3

SECONDARY outcome

Timeframe: Baseline to Day 5 post treatment administration

Population: Safety population: All randomized participants who received the study treatments were considered evaluable for safety.

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.

Outcome measures

Outcome measures
Measure	Nicotine Lozenge 4 mg n=161 Participants Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.	Matched Placebo n=162 Participants Participants received a single dose of matched placebo mint lozenge, through oral route.
Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs) AEs	12 Participants	54 Participants
Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs) Treatment Related AEs	11 Participants	54 Participants
Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs) SAEs	0 Participants	0 Participants

Adverse Events

Nicotine Lozenge 4 mg

Serious events: 0 serious events

Other events: 54 other events

Deaths: 0 deaths

Placebo Lozenge

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Nicotine Lozenge 4 mg n=162 participants at risk Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.	Placebo Lozenge n=161 participants at risk Participants received a single dose of matched placebo mint lozenge, through oral route.
Gastrointestinal disorders Nausea	14.8% 24/162 • Number of events 24 • 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.	0.62% 1/161 • Number of events 1 • 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.
Gastrointestinal disorders Dyspepsia	4.3% 7/162 • Number of events 7 • 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.	0.00% 0/161 • 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.
Gastrointestinal disorders Abdominal Discomfort	1.9% 3/162 • Number of events 3 • 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.	0.62% 1/161 • Number of events 1 • 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.
Gastrointestinal disorders Stomatitis	1.2% 2/162 • Number of events 2 • 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.	0.62% 1/161 • Number of events 1 • 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.
Gastrointestinal disorders Glossodynia	0.00% 0/162 • 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.	1.2% 2/161 • Number of events 2 • 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.
Gastrointestinal disorders Flatulence	0.62% 1/162 • Number of events 1 • 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.	0.00% 0/161 • 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.
Gastrointestinal disorders Oral Discomfort	0.62% 1/162 • Number of events 1 • 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.	0.00% 0/161 • 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.
Respiratory, thoracic and mediastinal disorders Hiccups	8.0% 13/162 • Number of events 13 • 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.	0.62% 1/161 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Throat Irritation	3.1% 5/162 • Number of events 5 • 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.	0.62% 1/161 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/162 • 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.	0.62% 1/161 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/162 • 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.	0.62% 1/161 • Number of events 1 • 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.
Nervous system disorders Dizziness	2.5% 4/162 • Number of events 4 • 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.	0.62% 1/161 • Number of events 1 • 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.
Nervous system disorders Headache	0.62% 1/162 • Number of events 1 • 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.	0.62% 1/161 • Number of events 1 • 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.
Investigations Heart Rate Increased	0.62% 1/162 • Number of events 1 • 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.	0.62% 1/161 • Number of events 1 • 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.
Psychiatric disorders Anxiety	0.62% 1/162 • Number of events 1 • 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.	0.62% 1/161 • Number of events 1 • 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.
Ear and labyrinth disorders Ear Pain	0.00% 0/162 • 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.	0.62% 1/161 • Number of events 1 • 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.