Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159571
Recruitment Status : Suspended (COVID 19)
First Posted : November 12, 2019
Last Update Posted : May 26, 2020
Sponsor:
Collaborator:
Virginia Tech Carilion School of Medicine and Research Institute
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Smoking Smoking Cessation Craving Addiction Addiction Nicotine Nicotine Dependence Cigarette Smoking Device: Real cTBS to the vmPFC Device: Sham cTBS to the vmPFC Device: Real iTBS to the dlPFC Device: Sham iTBS to the dlPFC Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Device Feasibility
Official Title: QuitFast: Evaluating Transcranial Magnetic Stimulation as a Tool to Reduce Smoking Directly Following a Quit Attempt
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: Real cTBS to the vmPFC
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 to the vmPFC
This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)

Sham Comparator: Sham cTBS to the vmPFC
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 to the vmPFC
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.

Experimental: Real iTBS to the dlPFC
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 to the dlPFC
This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).

Sham Comparator: Sham iTBS to the dlPFC
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 to the dlPFC
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.




Primary Outcome Measures :
  1. Neuroimaging outcomes: changes in drug cue reactivity as specified by changes in BOLD signal [ Time Frame: Through study completion, an average of 8 weeks ]
    The effect of real vs. sham iTBS to the left DLPFC vs. real vs. sham cTBS to the left MPFC as a tool to modulate the brain response to cigarette cravings will be assessed by comparing the brain activity in the executive circuit and limbic circuit before and after TMS. Participants will receive an MRI brain scan before their first TMS treatment, and at the end of their 10th days of TMS. At each MRI scan, participants will be subjected to a cigarette craving "cue" task within the scanner where elevated brain activity (BOLD signal) will be measured using an fMRI sequence. During each scan, they will see pictures of cigarette cues, neutral cues, and blurred images. The task is meant to induce craving and see how the brain responds to these craving cues.

  2. Changes in Delayed Discounting Cognitive Behavioral Task [ Time Frame: Through study completion, an average of 8 weeks ]
    Participants will be asked to choose between two conditions in which varying amounts and delays to behavioral outcomes (e.g., $50 now or $100 later) are presented. We will use magnitudes of $100 and $1000 which are the most thoroughly documented among the literature. Across consecutive choices, the delay to the larger outcome will be titrated until reaching the participant's indifference delay (i.e., the delay at which s/he equally values both options). This indifference delay indexes individual participants' rates of delay discounting. Monetary delay discounting has been documented to be predictive to treatment success for smokers.

  3. Questionnaire on Smoking Urges administered daily both pre/post TMS to measure craving [ Time Frame: Through study completion, an average of 8 weeks ]
    This 10-item questionnaire assesses cigarette craving. Participants will be asked to rate from 1 (strongly disagree) to 100 (strongly agree) their agreement with several statements (e.g., "I have a desire for a cigarette right now," and "Nothing would be better than smoking a cigarette right now."). Factor analyses support two factors: one that reflects a strong desire and intention to smoke and one that reflects relief from negative affect associated with an urgent desire to smoke.

  4. Hypothetical Purchase Task to measure tobacco product value and sensitivity [ Time Frame: Through study completion, an average of 8 weeks ]
    The hypothetical purchase task (HPT), a validated measure for cigarette demand, will assess cigarette purchases at various price conditions. Participants will hypothetically purchase quantities of cigarettes to use over a 24-hour period across ascending prices (e.g., $0, 0.12, $0.25, $0.50, $1.00, and $2.00 per cigarette). The HPT has been shown to be predictive of treatment outcomes. It will measure how participants value cigarettes throughout the course of the study visits.


Secondary Outcome Measures :
  1. Biochemical assessment of tobacco use via quantitative urine screens to detect cotenine level [ Time Frame: Through study completion, an average of 8 weeks ]
    Changes in cigarette use as detected by quantitative cotinine urine screens collected at visits 1, 6, 10, and all follow-ups

  2. Self- report assessment of tobacco use through Timeline Follow-Back (TLFB) Interview [ Time Frame: Through study completion, an average of 8 weeks ]
    This self-reported tobacco product use interview asks participants to retrospectively estimate the number of tobacco products they've used each day for the past 30 days or since the previous assessment, whichever is fewer.

  3. Biochemical assessment of recent tobacco use via breath Carbon Monoxide (CO) sample [ Time Frame: Through study completion, an average of 8 weeks ]
    Breath CO provides an accurate measure of recent exposure to CO, including from smoking combustible tobacco products (95). The CO measurement will be used to determine recency of smoking.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-70 (to maximize participation, and minimize effects of cortical atrophy on neuroimaging data)
  2. Current cigarette smoker (at least 10 cigarettes per day).
  3. Able to read and understand questionnaires and informed consent.
  4. Has accommodations within 50 miles of the study site.
  5. 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)
  6. Does not have metal objects in the head/neck.
  7. 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.
  8. Does not have a history of claustrophobia leading to significant clinical anxiety symptoms.

Exclusion Criteria:

  1. 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.
  2. Meets Diagnostic and Statistical Manual of Mental Disorders (DSM)-V 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.
  3. Has current suicidal ideation or homicidal ideation.
  4. Has the need for acute treatment with any psychoactive medication including anti-seizure medications and medications for attention-deficit/ hyperactivity disorder.
  5. Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
  6. Has current charges pending for a violent crime (not including DUI related offenses).
  7. Does not have a stable living situation.
  8. Suffers from chronic migraines.
  9. Does not have a stable phone number for contact through calling and/or texting.
  10. Does not have a stable means of using WebEx (e.g. personal computer, Internet) for interaction with study personnel during COVID-19.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159571


Locations
Layout table for location information
United States, North Carolina
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Virginia Tech Carilion School of Medicine and Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Colleen Hanlon, PhD Wake Forest University of Health Sciences
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04159571    
Other Study ID Numbers: IRB00061841
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be shared. All data is de-identified.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Wake Forest University Health Sciences:
Transcranial Magnetic Stimulation
Brain Stimulation
Treatment
Neuroimaging
Additional relevant MeSH terms:
Layout table for MeSH terms
Tobacco Use Disorder
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders