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A Controlled Laboratory Study of the Effects on Cue-Induced Craving in Dependent Smokers (rTMS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00901459
First received: May 11, 2009
Last updated: December 17, 2012
Last verified: December 2012
History of Changes
Results First Received: September 11, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Nicotine Dependence
Interventions: Device: Active rTMS Condition
Device: rTMS Location Control Condition
Device: rTMS Frequency Control Condition

  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
The first participant was consented on 5/12/2009 and the final participant on 6/22/2010 at the Duke Center for Nicotine and Smoking Cessation Research. During the recruitment phase of the study 148 potential subjects were consented and 7 read the consent form and chose not to participate.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Of the 148 participants that were consented for this study only 21 subjects met study criteria the others were excluded from participation for the following reasons:

70-Did Not Meet Inclusion Criteria 6-Lab Results 6-Lost to Contact 26-Medical 14-Met exclusion criteria 3-Refused to participate 2-Unable To Meet Study Requirements

Reporting Groups
  Description
All Study Participants

Active:

rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus

Location Control:

rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex

Frequency Control:

rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus

Participant Flow:   Overall Study
    All Study Participants  
STARTED     21  
COMPLETED     15  
NOT COMPLETED     6  
Withdrawal by Subject                 6  



  Baseline Characteristics
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Reporting Groups
  Description
All Study Participants

Active:

rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus

Location Control:

rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex

Frequency Control:

rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
 		  21  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     21  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  39.9  ± 8.88  
Gender  
[units: participants]
 		 
Female     9  
Male     12  
Region of Enrollment  
[units: participants]
 		 
United States     21  



  Outcome Measures
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1.  Primary:   Change in Craving for Cigarettes After Smoking Cues Versus Neutral Cues Using a Repeated Measure Design.   [ Time Frame: Following exposure to in vivo cues ]
  Show Outcome Measure 1

2.  Secondary:   Change in Craving for Cigarettes After Controlled Smoke Presentations.   [ Time Frame: After smoking a cigarette through the controlled puff volume apparatus during rTMS ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Jed E. Rose, Ph.D.
Organization: Duke Center for Nicotine and Smoking Cessation Research
phone: 919-668-5055
e-mail: jed.rose@mc.duke.edu


No publications provided by Duke University

Publications automatically indexed to this study:


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00901459     History of Changes
Other Study ID Numbers: Pro00002339
Study First Received: May 11, 2009
Results First Received: September 11, 2012
Last Updated: December 17, 2012
Health Authority: United States: Institutional Review Board