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
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.
No text entered.

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 ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  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:
unchecked 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.
unchecked 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.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


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