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Functional Magnetic Resonance Imaging (fMRI) Investigation of Nicotine Withdrawal Symptoms

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00657020
First Posted: April 14, 2008
Last Update Posted: March 2, 2015
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.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: October 12, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Smoking
Interventions: Drug: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 45 participants were screened, 22 were considered screen failures. Investigators identified brain regions showing significant blood oxygen-level dependent (BOLD) activation associated with attention in each participant using Functional Magnetic Resonance Imaging (fMRI). Hence, participants categorized into high/low attention conditions.

Reporting Groups
  Description
4 mg Nicotine Lozenge Then Placebo Lozenge Participants received nicotine lozenge containing 4 milligrams (mg) of nicotine in Period I and placebo lozenge in Period II.
Placebo Lozenge Then 4 mg Nicotine Lozenge Participants received placebo lozenge in Period I and nicotine 4 mg lozenge in Period II.

Participant Flow for 2 periods

Period 1:   PERIOD 1
    4 mg Nicotine Lozenge Then Placebo Lozenge   Placebo Lozenge Then 4 mg Nicotine Lozenge
STARTED   11   12 
COMPLETED   11   11 
NOT COMPLETED   0   1 
Adverse Event                0                1 

Period 2:   PERIOD 2
    4 mg Nicotine Lozenge Then Placebo Lozenge   Placebo Lozenge Then 4 mg Nicotine Lozenge
STARTED   11   11 
COMPLETED   11   11 
NOT COMPLETED   0   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
All Randomized Participants All randomized participants who receive study treatments.

Baseline Measures
   All Randomized Participants 
Overall Participants Analyzed 
[Units: Participants]
 23 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.82  (8.428) 
Gender 
[Units: Participants]
 
Female   5 
Male   18 
Race/Ethnicity, Customized 
[Units: Participants]
 
Caucasian   23 


  Outcome Measures
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1.  Primary:   Percent Mean Change in Blood Oxygen-level Dependent (BOLD) Scores During Rapid Visual Information Processing (RVIP) Task   [ Time Frame: Approximately 2 hours post dose administration ]

2.  Secondary:   Mean Response Time for Correct Responses During RVIP Task   [ Time Frame: Approximately 2 hours post dose administration ]

3.  Secondary:   Mean Percentage of Correct Responses During RVIP Task   [ Time Frame: Approximately 2 hours post dose administration ]

4.  Secondary:   Percent Mean Change in BOLD Scores During Divided Attention (DIA) Task   [ Time Frame: Approximately 2 hours post dose admininstration ]

5.  Secondary:   Mean Response Time for Correct Responses During DIA Task   [ Time Frame: Approximately 2 hours post dose administration ]

6.  Secondary:   Mean Percentage of Correct Responses During DIA Task   [ Time Frame: Approximately 2 hours post dose 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00657020     History of Changes
Other Study ID Numbers: S3250493
First Submitted: April 2, 2008
First Posted: April 14, 2008
Results First Submitted: October 12, 2009
Results First Posted: April 6, 2010
Last Update Posted: March 2, 2015