Provoked Craving Assessment

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01506908
• Collaborator: (none)
• Enrollment: 323
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 108

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Smoking Dependence; Smoking	Drug: oral nicotine; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 323 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Nicotine Mini Lozenge in Relief of Provoked Acute Craving
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Nicotine Polacrilex mint mini lozenge	Drug: oral nicotine; oral nicotine replacement product
Placebo Comparator: placebo mint mini lozenge with no active	Drug: Placebo; no active

Outcome Measures

Primary Outcome Measures

1. Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes [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.

Secondary Outcome Measures

1. Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute [Post-cue baseline, 1 minute post treatment administration]

   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.

2. Change From Post-cue Baseline in Nicotine Craving Score at 3 Minutes [Post-cue Baseline, 3 minutes post treatment administration]

   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.

3. Change From Post-cue Baseline in Nicotine Craving Score at 7 Minutes [Post-Cue Baseline, 7 minutes post treatment administration]

   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.

4. Change From Post-cue Baseline in Nicotine Craving Score at 10 Minutes [Post-Cue Baseline, 10 minutes post treatment administration]

   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. Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs) [Baseline to Day 5 post treatment administration]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Los Angeles Clinical Trials	Burbank	California	United States	91505

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01506908
• Other Study ID Numbers: S7121359
• First Posted: Jan 10, 2012
• Last Update Posted: Aug 28, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: craving
• Additional relevant MeSH terms: Nicotine

Study Results

Participant Flow

Recruitment Details	Participants were recruited at the clinical site.
Pre-assignment Detail	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.

Arm/Group Title	Nicotine Lozenge 4 Milligrams (mg)	Matched Placebo
Arm/Group Description	Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.	Participants received a single dose of matched placebo mint lozenge, through oral route.
Period Title: Overall Study
STARTED	162	161
COMPLETED	161	161
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Nicotine Lozenge 4 mg	Matched Placebo	Total
Arm/Group Description	Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.	Participants received a single dose of matched placebo mint lozenge, through oral route.	Total of all reporting groups
Overall Participants	162	161	323
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	43.69 (12.13)	44.45 (11.64)	44.07 (11.88)
Sex: Female, Male (Count of Participants)
Female	75 46.3%	74 46%	149 46.1%
Male	87 53.7%	87 54%	174 53.9%
Body Mass Index (Kilograms (kg)/ meter (m)^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kilograms (kg)/ meter (m)^2]	27.79 (3.73)	27.56 (4.05)	27.67 (3.89)

Outcome Measures

1. Primary Outcome

Title	Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes
Description	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.
Time Frame	Post-cue baseline,5 minutes

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Nicotine Lozenge 4 mg	Matched Placebo
Arm/Group Description	Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.	Participants received a single dose of matched placebo mint lozenge, through oral route.
Measure Participants	162	161
Least Squares Mean (95% Confidence Interval) [Score on a scale]	-41.8	-25.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Nicotine Lozenge 4 mg, Matched Placebo
	Comments	Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 5 minutes
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares means difference
	Estimated Value	-15.9
	Confidence Interval	(2-Sided) 95%; -21.6 to -10.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.

2. Secondary Outcome

Title	Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute
Description	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.
Time Frame	Post-cue baseline, 1 minute post treatment administration

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Nicotine Lozenge 4 mg	Matched Placebo
Arm/Group Description	Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.	Participants received a single dose of matched placebo mint lozenge, through oral route.
Measure Participants	162	161
Least Squares Mean (95% Confidence Interval) [Score on a scale]	-17.2	-12.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Nicotine Lozenge 4 mg, Matched Placebo
	Comments	Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 1 minute.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0511
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares means difference
	Estimated Value	-4.2
	Confidence Interval	(2-Sided) 95%; -8.4 to 0.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.

3. Secondary Outcome

Title	Change From Post-cue Baseline in Nicotine Craving Score at 3 Minutes
Description	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.
Time Frame	Post-cue Baseline, 3 minutes post treatment administration

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Nicotine Lozenge 4 mg	Matched Placebo
Arm/Group Description	Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.	Participants received a single dose of matched placebo mint lozenge, through oral route.
Measure Participants	162	161
Least Squares Mean (95% Confidence Interval) [Score on a scale]	-31.1	-19.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Nicotine Lozenge 4 mg, Matched Placebo
	Comments	Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 3 minutes.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares means difference
	Estimated Value	-11.6
	Confidence Interval	(2-Sided) 95%; -16.7 to -6.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.

4. Secondary Outcome

Title	Change From Post-cue Baseline in Nicotine Craving Score at 7 Minutes
Description	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.
Time Frame	Post-Cue Baseline, 7 minutes post treatment administration

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Nicotine Lozenge 4 mg	Matched Placebo
Arm/Group Description	Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.	Participants received a single dose of matched placebo mint lozenge, through oral route.
Measure Participants	162	161
Least Squares Mean (95% Confidence Interval) [Score on a scale]	-48.2	-30.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Nicotine Lozenge 4 mg, Matched Placebo
	Comments	Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 7 minutes.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares means difference
	Estimated Value	-17.8
	Confidence Interval	(2-Sided) 95%; -23.8 to -11.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.

5. Secondary Outcome

Title	Change From Post-cue Baseline in Nicotine Craving Score at 10 Minutes
Description	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.
Time Frame	Post-Cue Baseline, 10 minutes post treatment administration

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Nicotine Lozenge 4 mg	Matched Placebo
Arm/Group Description	Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.	Participants received a single dose of matched placebo mint lozenge, through oral route.
Measure Participants	162	161
Least Squares Mean (95% Confidence Interval) [Score on a scale]	-50.8	-32.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Nicotine Lozenge 4 mg, Matched Placebo
	Comments	Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 10 minutes.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least square mean difference
	Estimated Value	-17.9
	Confidence Interval	(2-Sided) 95%; -24.4 to -11.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.

6. Secondary Outcome

Title	Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs)
Description	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.
Time Frame	Baseline to Day 5 post treatment administration

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Matched Placebo	Nicotine Lozenge 4 mg
Arm/Group Description	Participants received a single dose of matched placebo mint lozenge, through oral route.	Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
Measure Participants	161	162
AEs	12 7.4%	54 33.5%
Treatment Related AEs	11 6.8%	54 33.5%
SAEs	0 0%	0 0%

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.
Arm/Group Title	Nicotine Lozenge 4 mg		Placebo Lozenge
Arm/Group Description	Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.		Participants received a single dose of matched placebo mint lozenge, through oral route.
All Cause Mortality
	Nicotine Lozenge 4 mg		Placebo Lozenge
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Nicotine Lozenge 4 mg		Placebo Lozenge
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/162 (0%)		0/161 (0%)
Other (Not Including Serious) Adverse Events
	Nicotine Lozenge 4 mg		Placebo Lozenge
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	54/162 (33.3%)		12/161 (7.5%)
Ear and labyrinth disorders
Ear Pain	0/162 (0%)	0	1/161 (0.6%)	1
Gastrointestinal disorders
Nausea	24/162 (14.8%)	24	1/161 (0.6%)	1
Dyspepsia	7/162 (4.3%)	7	0/161 (0%)	0
Abdominal Discomfort	3/162 (1.9%)	3	1/161 (0.6%)	1
Stomatitis	2/162 (1.2%)	2	1/161 (0.6%)	1
Glossodynia	0/162 (0%)	0	2/161 (1.2%)	2
Flatulence	1/162 (0.6%)	1	0/161 (0%)	0
Oral Discomfort	1/162 (0.6%)	1	0/161 (0%)	0
Investigations
Heart Rate Increased	1/162 (0.6%)	1	1/161 (0.6%)	1
Nervous system disorders
Dizziness	4/162 (2.5%)	4	1/161 (0.6%)	1
Headache	1/162 (0.6%)	1	1/161 (0.6%)	1
Psychiatric disorders
Anxiety	1/162 (0.6%)	1	1/161 (0.6%)	1
Respiratory, thoracic and mediastinal disorders
Hiccups	13/162 (8%)	13	1/161 (0.6%)	1
Throat Irritation	5/162 (3.1%)	5	1/161 (0.6%)	1
Nasal Congestion	0/162 (0%)	0	1/161 (0.6%)	1
Oropharyngeal Pain	0/162 (0%)	0	1/161 (0.6%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.