Theta Burst TMS as a Tool to Change Smoking Behavior

July 19, 2018 updated by: Medical University of South Carolina
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: real treatment
continuous theta burst stimulation (real) will be delivered
Device: continuous theta burst stimulation (real)
a form of transcranial magnetic stimulation that noninvasively induces a depression in brain reactivity
Other Names:
  • cTBS (active)
Sham Comparator: sham treatment
continuous theta burst stimulation (sham) will be delivered
Device: continuous theta burst stimulation (sham)
a sham version of a form of transcranial magnetic stimulation that noninvasively induces a depression in brain reactivity
Other Names:
  • cTBS (sham)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent BOLD signal change in the MPFC
Time Frame: immediately after the treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: Colleen A Hanlon, Ph.D., Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

September 1, 2016

First Submitted That Met QC Criteria

October 18, 2016

First Posted (Estimate)

October 20, 2016

Study Record Updates

Last Update Posted (Actual)

July 23, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00042165

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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