Provoked Craving Assessment

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited at the clinical site.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
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.

Participant Flow:   Overall Study

	Nicotine Lozenge 4 Milligrams (mg)	Matched Placebo
STARTED	162	161
COMPLETED	161	161
NOT COMPLETED	1	0
Adverse Event	1	0

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Nicotine Lozenge 4 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.
Total	Total of all reporting groups

Baseline Measures

	Nicotine Lozenge 4 mg	Matched Placebo	Total
Overall Participants Analyzed  [Units: Participants]	162	161	323
Age  [Units: Years] Mean (Standard Deviation)	43.69  (12.13)	44.45  (11.64)	44.07  (11.88)
Gender  [Units: Participants]
Female	75	74	149
Male	87	87	174
Body Mass Index  [Units: Kilograms (kg)/ meter (m)^2] Mean (Standard Deviation)	27.79  (3.73)	27.56  (4.05)	27.67  (3.89)

1.  Primary:

Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes   [ Time Frame: Post-cue baseline,5 minutes ]

2.  Secondary:

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

3.  Secondary:

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

4.  Secondary:

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

5.  Secondary:

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

6.  Secondary:

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

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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