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Trial record 4 of 6 for:    Colleen Hanlon

Theta Burst TMS as a Tool to Change Smoking Behavior

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ClinicalTrials.gov Identifier: NCT02939339
Recruitment Status : Recruiting
First Posted : October 20, 2016
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Colleen Hanlon, Medical University of South Carolina

Brief 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.

Condition or disease Intervention/treatment Phase
Smoking Addiction Device: continuous theta burst stimulation (real) Device: continuous theta burst stimulation (sham) Phase 2

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Theta Burst TMS as a Tool to Change Smoking Behavior
Study Start Date : October 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

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 Name: 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 Name: cTBS (sham)



Primary Outcome Measures :
  1. Percent BOLD signal change in the MPFC [ Time Frame: immediately after the treatment ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939339


Contacts
Contact: Colleen A Hanlon, Ph.D. (843)792-5732 hanlon@musc.edu
Contact: Millie H Griffin, B.A. (843) 792-2335 grifm@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Colleen A Hanlon, Ph.D.    843-792-5732    hanlon@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Colleen A Hanlon, Ph.D. Medical University of South Carolina

Publications:

Responsible Party: Colleen Hanlon, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02939339     History of Changes
Other Study ID Numbers: 00042165
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Colleen Hanlon, Medical University of South Carolina:
Transcranial Magnetic Stimulation