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Changing Thought and Action in Tobacco Dependence With Transcranial Magnetic Stimulation (rTMS)

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ClinicalTrials.gov Identifier: NCT00973622
Recruitment Status : Completed
First Posted : September 9, 2009
Results First Posted : September 24, 2013
Last Update Posted : September 24, 2013
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Tobacco Dependence
Interventions Device: repetitive transcranial magnetic stimulation (rTMS) 10 Hertz (Hz)
Device: repetitive transcranial magnetic stimulation (rTMS) 20Hz
Device: SHAM repetitive transcranial magnetic stimulation (rTMS)
Enrollment 66
Recruitment Details Participants were recruited from 11/4/2009 to 9/19/2011 from the surrounding community using primarily newspaper advertisements and word of mouth.
Pre-assignment Details Enrolled participants were scheduled for an MRI of the head and needed to pass the MRI-screen (i.e., have no significant brain abnormalities) to continue with the study. Of the 49 participants who obtained an MRI, 6 participants did not pass this screen.
Arm/Group Title Smokers Non-smokers
Hide Arm/Group Description Smokers were healthy adults between the ages of 19 and 55 years who had no intention of quitting smoking before the end of the study. Healthy adult non-smokers who were between the ages of aged 19-55 years.
Period Title: Overall Study
Started 47 [1] 19 [2]
Completed 16 [3] 14 [3]
Not Completed 31 5
Reason Not Completed
did not attend MRI             14             3
did not pass MRI screen             6             0
did not complete rTMS sessions             11             2
[1]
75 passed telephone interview; 28 passed in-person interview, were enrolled, and sent for MRI.
[2]
21 passed telephone interview; 19 passed the in-person interview, were enrolled, and sent for MRI.
[3]
Completed three sessions of rTMS
Arm/Group Title Smokers Nonsmokers Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 47 19 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 19 participants 66 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
47
 100.0%
19
 100.0%
66
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 19 participants 66 participants
42.38  (10.01) 39.16  (11.21) 41.45  (10.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 19 participants 66 participants
Female
14
  29.8%
12
  63.2%
26
  39.4%
Male
33
  70.2%
7
  36.8%
40
  60.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 47 participants 19 participants 66 participants
47 19 66
1.Primary Outcome
Title A Difference Score for the Log Value of K.
Hide Description K is a output value, a summary statistic, derived from a hyperbolic function that summarizes the rate at which monetary values are discounted according to the time they are received. The value of K can either increase or decrease from its baseline value. For example, an increase in K would indicate that the participant is choosing to receive larger amounts of money at a later point in time. A decrease would suggest the opposite - lesser amounts of money at an earlier point in time). The difference score is calculated from baseline to that immediately after 10 or 20 Hz rTMS.
Time Frame baseline and immediately after stimulation, an average of 25 seconds.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that attended at least one session and provided at least some outcome data were included in the analyses
Arm/Group Title Smokers Non-smokers
Hide Arm/Group Description:
Healthy adult smokers aged 19-55 who are not currently interested in quitting smoking.
Healthy adult non-smokers aged 19-55
Overall Number of Participants Analyzed 23 16
Log Mean (Standard Deviation)
Unit of Measure: log transformed values of K
-1.2215  (3.05) -1.6742  (2.29)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Smokers Non-smokers
Hide Arm/Group Description Healthy adult smokers aged 19-55 who are not currently interested in quitting smoking. Healthy adult non-smokers aged 19-55
All-Cause Mortality
Smokers Non-smokers
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Smokers Non-smokers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/19 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Smokers Non-smokers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/19 (0.00%) 
We experienced significant subject attrition among smokers. We did not experience such attrition among nonsmokers. Also, six smokers were withdrawn because the MRI screen revealed brain abnormalities. No nonsmokers were withdrawn for this reason.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christine Sheffer, PhD
Organization: University of Arkansas for Medical Sciences
Phone: 212 650 6860
EMail: csheffer@med.cuny.edu
Layout table for additonal information
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00973622    
Other Study ID Numbers: 110881
First Submitted: August 26, 2009
First Posted: September 9, 2009
Results First Submitted: January 23, 2013
Results First Posted: September 24, 2013
Last Update Posted: September 24, 2013