Provoked Craving Assessment
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01506908 |
Recruitment Status :
Completed
First Posted : January 10, 2012
Results First Posted : January 30, 2014
Last Update Posted : August 28, 2019
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Conditions |
Smoking Dependence Smoking |
Interventions |
Drug: oral nicotine Drug: Placebo |
Enrollment | 323 |
Participant Flow
Recruitment Details | Participants were recruited at the clinical site. |
Pre-assignment Details | 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 |
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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 |
Reason Not Completed | ||
Adverse Event | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Nicotine Lozenge 4 mg | Matched Placebo | Total | |
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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 Number of Baseline Participants | 162 | 161 | 323 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 162 participants | 161 participants | 323 participants | |
43.69 (12.13) | 44.45 (11.64) | 44.07 (11.88) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 162 participants | 161 participants | 323 participants | |
Female |
75 46.3%
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74 46.0%
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149 46.1%
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Male |
87 53.7%
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87 54.0%
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174 53.9%
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Body Mass Index
Mean (Standard Deviation) Unit of measure: Kilograms (kg)/ meter (m)^2 |
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Number Analyzed | 162 participants | 161 participants | 323 participants | |
27.79 (3.73) | 27.56 (4.05) | 27.67 (3.89) |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01506908 |
Other Study ID Numbers: |
S7121359 |
First Submitted: | December 15, 2011 |
First Posted: | January 10, 2012 |
Results First Submitted: | December 12, 2013 |
Results First Posted: | January 30, 2014 |
Last Update Posted: | August 28, 2019 |