Nicotine TMS EFT Smoking Pilot Study

Sponsor

Medical University of South Carolina (Other)

Overall Status

Completed

CT.gov ID

NCT03579953

Collaborator

(none)

Enrollment

Location

Arms

12.6

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Nicotine Dependence Addiction Smoking, Cigarette	Device: Real cTBS Device: Sham cTBS	Early Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Theta-Burst Stimulation As A Tool To Change Smoking Behavior

Actual Study Start Date :

May 22, 2018

Actual Primary Completion Date :

Jun 10, 2019

Actual Study Completion Date :

Jun 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Real cTBS to MPFC 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).	Device: Real cTBS This will be delivered with the Magventure Magpro system; 3600 pulses with the active sham coil (double blinded using the USB key).
Sham Comparator: Sham cTBS to MPFC 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).	Device: Sham cTBS 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.

Arm

Intervention/Treatment

Experimental: Real cTBS to MPFC

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).

Device: Real cTBS

This will be delivered with the Magventure Magpro system; 3600 pulses with the active sham coil (double blinded using the USB key).

Sham Comparator: Sham cTBS to MPFC

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).

Device: Sham cTBS

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.

Outcome Measures

Primary Outcome Measures

Changes in craving after a single session of cTBS [For the duration of the study, approximately 24 hours following real or sham 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 [For the duration of the study, approximately 24 hours following real or sham 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

Medical University of South Carolina

Investigators

Principal Investigator: Colleen A Hanlon, PhD, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT03579953

Other Study ID Numbers:

74722

First Posted:

Jul 9, 2018

Last Update Posted:

Aug 14, 2019

Last Verified:

Aug 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Medical University of South Carolina

Brain Stimulation

Additional relevant MeSH terms:

Tobacco Use Disorder

Study Results

No Results Posted as of Aug 14, 2019