QuitFast: Evaluating Transcranial Magnetic Stimulation as a Tool to Reduce Smoking Directly Following a Quit Attempt

NCT03576768 | Terminated Results DMC FDA Device

• 1 other identifier: 00074769
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Cigarette smoking constitutes the greatest preventable cause of mortality and morbidity in the US. The most critical period for long term success of smoking cessation appears to be in the first 7 days after the quit date. A metaanalysis of 3 pharmacotherapy trials revealed that abstinence during the first 7 days was the strongest predictor of 6 month outcomes (n=1649; Odds ratio: 1.4, P \<0.0001; Ashare et al. 2013). Prodigious relapse rates during this first week of smoking cessation are likely due to behavioral and neurobiological factors that contribute to high cue-associated craving and low executive control over smoking. The long term goal of the research is to develop evidence-based transcranial magnetic stimulation protocols to facilitate abstinence during this critical period.

Conditions

Smoking, Cigarette; Craving; Addiction; Nicotine

Keywords

Transcranial Magnetic Stimulation; Brain Stimulation; Treatment; Neuroimaging

Outcome Measures

Primary Outcomes (1)

• Change in Cigarette Dependence After 10 Days of Treatment

  The Fagerstrom Test for Nicotine Dependence will be measured at Visit 1 and after 10 days of treatment (Visit 10). In scoring the Fagerstrom Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerstrom score, the more intense is the patient's physical dependence on nicotine. .For this outcome we will measure the difference in the score for those that completed the study. This difference will be compared between the study arms.

  Baseline and 10 days

Secondary Outcomes (2)

• Change in Urge for a Cigarette

  Baseline and 10 days

• Changes in Cigarette Use

  Baseline and 10 days

Study Arms (4)

Real cTBS to the vmPFC

EXPERIMENTAL

Ten sessions of real continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total)

Device: Real cTBS

Sham cTBS to the vmPFC

SHAM COMPARATOR

Ten sessions of sham continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total)

Device: Sham cTBS

Real iTBS to the dlPFC

EXPERIMENTAL

Ten sessions of real intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total)

Device: Real iTBS

Sham iTBS to the dlPFC

SHAM COMPARATOR

Ten sessions of sham intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total)

Device: Sham iTBS

Interventions

Real cTBS DEVICE

This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)

Real cTBS to the vmPFC

Sham cTBS DEVICE

This will be delivered with the Magventure Magpro system; 600 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 the vmPFC

Real iTBS DEVICE

This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).

Real iTBS to the dlPFC

Sham iTBS DEVICE

This will be delivered with the Magventure Magpro system; 600 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 iTBS to the dlPFC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 70 (to maximize participation, and minimize effects of cortical atrophy on neuroimaging data)
• Current cigarette smoker
• Able to read and understand questionnaires and informed consent.
• Has accommodations within 50 miles of the study site.
• Is not at elevated risk of seizure (i.e., does not have a history of seizures, is not currently prescribed medications known to lower seizure threshold)
• Does not have metal objects in the head/neck.
• Does not have a history of traumatic brain injury, including a head injury that resulted in hospitalization, loss of consciousness for more than 10 minutes, or having ever been informed that they have an epidural, subdural, or subarachnoid hemorrhage.
• Does not have a history of claustrophobia leading to significant clinical anxiety symptoms.

You may not qualify if:

• Any psychoactive illicit substance use (except marijuana, alcohol, and nicotine) within the last 30 days by self-report and urine drug screen. For marijuana, no use within the last seven days by verbal report and negative (or decreasing) urine THC levels. Participation will be discontinued if participants use psychoactive illicit substances (except nicotine and alcohol) after study initiation.
• Meets DSM IV criteria for current axis I disorders of major depression, panic disorder, obsessive-compulsive disorder, post traumatic stress syndrome, bipolar affective disorder, schizophrenia, dissociate disorders, eating disorders, and any other psychotic disorder or organic mental disorder.
• Has current suicidal ideation or homicidal ideation.
• Has the need for r acute treatment with any psychoactive medication including anti-seizure medications and medications for ADHD.
• Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
• Has current charges pending for a violent crime (not including DUI related offenses).
• Does not have a stable living situation.
• Suffers from chronic migraines.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Virginia Tech Carilion School of Medicine and Research Institute: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Behavior, Addictive

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Compulsive Behavior; Impulsive Behavior

Results Point of Contact

• Title: Colleen Hanlon, PhD
• Organization: Medical University of South Carolina

hanlon@musc.edu

843-792-9888

Study Officials

• Colleen A Hanlon, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• 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 3, 2018
• Study Start: September 4, 2018
• Primary Completion: October 25, 2019
• Study Completion: October 25, 2019
• Last Updated: March 24, 2021
• Results First Posted: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)