Theta Burst TMS as a Tool to Change Smoking Behavior

Smoking Clinical Trial

Official title:

Theta Burst TMS as a Tool to Change Smoking Behavior

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02939339
• Other study ID #: 00042165
• Status: Completed
• Phase: Early Phase 1
• Start date: October 2015
• Est. completion date: August 1, 2017

Study information

• Verified date: July 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to determine whether transcranial magnetic stimulation (TMS) is an effective treatment in decreasing craving in individuals who habitually smoke cigarettes. The study consists of six total visits to MUSC; one for the consent process, two that will include MRI scans, and five that will include TMS administration. Compensation will be provided for each visit.

Description:

Prior and recent evidence suggests a role of medial prefrontal cortex (mPFC) in cigarette smoking. The present study will examine whether a five-day regimen of theta-burst transcranial magnetic stimulation (TMS) reduces cigarette smoking outside of the lab (examined through self-report and physiological measures) and motivation to smoke inside the lab (examined through behavioral tasks and functional MRI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• smoke at least 10 cigarettes a day (on average)

Exclusion Criteria:

• comorbid mental or physical illness (managed or unmanaged)

• pregnancy

• use of prescription medication that might affect smoking or nicotine metabolism,

• use of smokeless tobacco or alternative nicotine products

• use illicit drugs of abuse (verified through urine screen and self-report),

• score of above a 7 on the Alcohol Use Disorders Identification Test (indicative of non-risky use),

• a history of epilepsy or seizures not otherwise specified (other than childhood febrile seizures)

• a history of chronic migraines,

• failure to meet all criteria on a standardized MRI/TMS safety screen (including but not limited to implanted electronic devices, bullets or metallic fragments above the waist, hair clips and piercings above the waist that cannot be removed)

• presence of any barriers to making contact between the TMS coil and the skin (e.g. cornrows that cannot be removed, glasses that the participant is unwilling to remove).

Related Conditions & MeSH terms

• Addiction
• Smoking

Intervention

Device:
• continuous theta burst stimulation (real)
a form of transcranial magnetic stimulation that noninvasively induces a depression in brain reactivity
• continuous theta burst stimulation (sham)
a sham version of a form of transcranial magnetic stimulation that noninvasively induces a depression in brain reactivity

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent BOLD signal change in the MPFC	The effect of real vs. sham cTBS to the leftt MPFC as a tool to modulate the brain response to craving will be assessed by comparing the brain activity in the limbic circuit before and after TMS.	immediately after the treatment