Trial Outcomes & Findings for Changing Thought and Action in Tobacco Dependence With Transcranial Magnetic Stimulation (NCT NCT00973622)

NCT ID: NCT00973622

Last Updated: 2013-09-24

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 66 participants
• Primary outcome timeframe: baseline and immediately after stimulation, an average of 25 seconds.
• Results posted on: 2013-09-24

Participant Flow

Participants were recruited from 11/4/2009 to 9/19/2011 from the surrounding community using primarily newspaper advertisements and word of mouth.

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.

Participant milestones

Measure	Smokers 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.	Non-smokers Healthy adult non-smokers who were between the ages of aged 19-55 years.
Overall Study STARTED	47	19
Overall Study COMPLETED	16	14
Overall Study NOT COMPLETED	31	5

Reasons for withdrawal

Measure	Smokers 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.	Non-smokers Healthy adult non-smokers who were between the ages of aged 19-55 years.
Overall Study did not attend MRI	14	3
Overall Study did not pass MRI screen	6	0
Overall Study did not complete rTMS sessions	11	2

Baseline Characteristics

Changing Thought and Action in Tobacco Dependence With Transcranial Magnetic Stimulation

Baseline characteristics by cohort

Measure	Smokers n=47 Participants	Nonsmokers n=19 Participants	Total n=66 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=5 Participants	19 Participants n=7 Participants	66 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	42.38 years STANDARD_DEVIATION 10.01 • n=5 Participants	39.16 years STANDARD_DEVIATION 11.21 • n=7 Participants	41.45 years STANDARD_DEVIATION 10.39 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	7 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants	19 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and immediately after stimulation, an average of 25 seconds.

Population: All participants that attended at least one session and provided at least some outcome data were included in the analyses

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.

Outcome measures

Measure	Smokers n=23 Participants Healthy adult smokers aged 19-55 who are not currently interested in quitting smoking.	Non-smokers n=16 Participants Healthy adult non-smokers aged 19-55
A Difference Score for the Log Value of K.	-1.2215 log transformed values of K Standard Deviation 3.05	-1.6742 log transformed values of K Standard Deviation 2.29

Adverse Events

Smokers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-smokers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christine Sheffer, PhD

University of Arkansas for Medical Sciences

Phone: 212 650 6860

Email: csheffer@med.cuny.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place