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Nicotine TMS EFT Smoking Pilot Study

Primary Purpose

Smoking, Nicotine Dependence, Addiction

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Real cTBS
Sham cTBS
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking focused on measuring Brain Stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18-65 years of age
  2. Smoke at least 10 cigarettes a day (on average)
  3. Not be pregnant
  4. Meet all criteria on a standardized TMS safety screen (including to but not limited to implanted electronic devices, bullets or metallic fragments above the neck, hair clips that cannot be removed)
  5. No 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)

Exclusion Criteria:

  1. Report comorbid mental or physical illness (managed or unmanaged)
  2. Currently using prescription medication that might affect smoking or nicotine metabolism
  3. Using smokeless tobacco or alternative nicotine products
  4. History of epilepsy or seizures (other than childhood febrile seizures)
  5. History of chronic migraines

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real cTBS to MPFC

Sham cTBS to MPFC

Arm Description

One session of real cTBS treatment delivered to the medial prefrontal cortex (MPFC) (2 trains of stimulation over the MPFC as defined by EEG coordinates (FP1); each train: 120 sec, 3 pulse bursts presented at 5Hz, 15 pulses/sec, 1800 pulses/train, 60 sec intertrain interval; 110% RMT, MagPro X100 Cool Coil; 3600 pulses total).

One session of sham cTBS treatment delivered to the medial prefrontal cortex (MPFC) (2 trains of stimulation over the MPFC as defined by EEG coordinates (FP1); each train: 120 sec, 3 pulse bursts presented at 5Hz, 15 pulses/sec, 1800 pulses/train, 60 sec intertrain interval; 110% RMT, MagPro X100 Cool Coil; 3600 pulses total).

Outcomes

Primary Outcome Measures

Changes in craving after a single session of cTBS
The effect of real versus sham cTBS on nicotine craving will be assessed by comparing pre-TMS and post-TMS changes in nicotine craving scores.

Secondary Outcome Measures

Changes in delayed discounting after a single session of cTBS
The effect of real versus sham cTBS on nicotine craving will be assessed by comparing pre-TMS and post-TMS changes in delayed discounting scores.

Full Information

First Posted
June 12, 2018
Last Updated
August 13, 2019
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03579953
Brief Title
Nicotine TMS EFT Smoking Pilot Study
Official Title
Theta-Burst Stimulation As A Tool To Change Smoking Behavior
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 22, 2018 (Actual)
Primary Completion Date
June 10, 2019 (Actual)
Study Completion Date
June 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Prior and recent evidence suggests a role of medial prefrontal cortex (MPFC) in cigarette smoking. Episodic Future Thinking (EFT) has also been shown to be associated with increased delayed discounting and reduced cigarette self administration. In the present study, we will examine whether a single administration of theta-burst transcranial magnetic stimulation (tbTMS) can increase Episodic Future Thinking and delayed discounting while reducing craving for nicotine.
Detailed Description
The purpose of this study is to develop theta burst transcranial magnetic stimulation (tbTMS) as a potential treatment for nicotine addiction. Theta burst TMS is a non-invasive technique that uses magnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). This study will test whether tbTMS over the forehead can produce a reduction in things that may prompt individuals to want to smoke cigarettes. TMS has been approved by the Food and Drug Administration as an investigational tool as well as a therapy for depression. However, TMS is not approved by the Food and Drug Administration as a treatment for nicotine cravings and other addictions. This study consists of one consent session and one TMS session. Participants will be asked to complete a series of questionnaires and computer assessments about nicotine both before and after a single tbTMS session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Nicotine Dependence, Addiction, Smoking, Cigarette
Keywords
Brain Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real cTBS to MPFC
Arm Type
Experimental
Arm Description
One session of real cTBS treatment delivered to the medial prefrontal cortex (MPFC) (2 trains of stimulation over the MPFC as defined by EEG coordinates (FP1); each train: 120 sec, 3 pulse bursts presented at 5Hz, 15 pulses/sec, 1800 pulses/train, 60 sec intertrain interval; 110% RMT, MagPro X100 Cool Coil; 3600 pulses total).
Arm Title
Sham cTBS to MPFC
Arm Type
Sham Comparator
Arm Description
One session of sham cTBS treatment delivered to the medial prefrontal cortex (MPFC) (2 trains of stimulation over the MPFC as defined by EEG coordinates (FP1); each train: 120 sec, 3 pulse bursts presented at 5Hz, 15 pulses/sec, 1800 pulses/train, 60 sec intertrain interval; 110% RMT, MagPro X100 Cool Coil; 3600 pulses total).
Intervention Type
Device
Intervention Name(s)
Real cTBS
Intervention Description
This will be delivered with the Magventure Magpro system; 3600 pulses with the active sham coil (double blinded using the USB key).
Intervention Type
Device
Intervention Name(s)
Sham cTBS
Intervention Description
This will be delivered with the sham Magventure Magpro system; 3600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
Primary Outcome Measure Information:
Title
Changes in craving after a single session of cTBS
Description
The effect of real versus sham cTBS on nicotine craving will be assessed by comparing pre-TMS and post-TMS changes in nicotine craving scores.
Time Frame
For the duration of the study, approximately 24 hours following real or sham cTBS
Secondary Outcome Measure Information:
Title
Changes in delayed discounting after a single session of cTBS
Description
The effect of real versus sham cTBS on nicotine craving will be assessed by comparing pre-TMS and post-TMS changes in delayed discounting scores.
Time Frame
For the duration of the study, approximately 24 hours following real or sham cTBS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-65 years of age Smoke at least 10 cigarettes a day (on average) Not be pregnant Meet all criteria on a standardized TMS safety screen (including to but not limited to implanted electronic devices, bullets or metallic fragments above the neck, hair clips that cannot be removed) No 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) Exclusion Criteria: Report comorbid mental or physical illness (managed or unmanaged) Currently using prescription medication that might affect smoking or nicotine metabolism Using smokeless tobacco or alternative nicotine products History of epilepsy or seizures (other than childhood febrile seizures) History of chronic migraines
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen A Hanlon, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Nicotine TMS EFT Smoking Pilot Study

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