Provoked Craving Assessment

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01506908

First received: December 15, 2011

Last updated: February 6, 2014

Last verified: December 2013

History of Changes

Results First Received: December 12, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Smoking Dependence Smoking
Interventions:	Drug: oral nicotine Drug: Placebo

Participant Flow

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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

Baseline Characteristics

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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
Number of Participants [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)

Outcome Measures

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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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 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01506908 History of Changes
Other Study ID Numbers:	S7121359
Study First Received:	December 15, 2011
Results First Received:	December 12, 2013
Last Updated:	February 6, 2014
Health Authority:	United States: Food and Drug Administration

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