Nicotine TMS EFT Smoking Pilot Study

Smoking Clinical Trial

Official title:

Theta-Burst Stimulation As A Tool To Change Smoking Behavior

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03579953
• Other study ID #: 74722
• Status: Completed
• Phase: Early Phase 1
• Start date: May 22, 2018
• Est. completion date: June 10, 2019

Study information

• Verified date: August 2019
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 10, 2019
• Est. primary completion date: June 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Addiction
• Nicotine Dependence
• Smoking
• Smoking, Cigarette
• Tobacco Use Disorder

Intervention

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 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.

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	For the duration of the study, approximately 24 hours following real or sham cTBS
Secondary	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.	For the duration of the study, approximately 24 hours following real or sham cTBS