Nicotine TMS EFT Smoking Pilot Study

NCT03579953 | Completed Early Phase 1 DMC

• 1 other identifier: 74722
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Nicotine Dependence; Addiction; Smoking, Cigarette

Keywords

Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in delayed discounting after a single session of cTBS

  For the duration of the study, approximately 24 hours following real or sham cTBS

Study Arms (2)

Real cTBS to MPFC

EXPERIMENTAL

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

Sham cTBS to MPFC

SHAM COMPARATOR

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

Interventions

Real cTBS DEVICE

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

Real cTBS to MPFC

Sham cTBS DEVICE

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.

Sham cTBS to MPFC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Smoking; Tobacco Use Disorder; Behavior, Addictive; Cigarette Smoking

Condition Hierarchy (Ancestors)

Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Tobacco Smoking; Tobacco Use

Study Officials

• Colleen A Hanlon, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: July 9, 2018
• Study Start: May 22, 2018
• Primary Completion: June 10, 2019
• Study Completion: June 10, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)