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

NCT04159571 | Completed Results DMC FDA Device

• 1 other identifier: IRB00061841
• Study Type: interventional
• Target: 40
• 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; Smoking Cessation; Craving; Addiction; Addiction Nicotine; Nicotine Dependence; Cigarette Smoking

Keywords

Transcranial Magnetic Stimulation; Brain Stimulation; Treatment; Neuroimaging

Outcome Measures

Primary Outcomes (2)

• Questionnaire on Smoking Urges Administered Daily Pre TMS to Measure Craving

  Questionnaire on Smoking Urges (QSU). This 10-item questionnaire assesses cigarette craving. Participants will be asked to rate from 1 (strongly disagree) to 7 (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."). Individual scores can range from 7 to 49. Higher scores represent more craving. QSU scores are averaged per individual per time point. Scores for all time points and all participants were averaged for each arm (real vs sham TMS).

  Through study completion, an average of 8 weeks

• Self- Report Assessment of Cigarette Use Through Timeline Follow-Back (TLFB) Interview

  This self-reported tobacco product use interview asks participants to retrospectively estimate the number of cigarettes they've used each day for the past 30 days or since the previous assessment, whichever is fewer.

  Through study completion, an average of 8 weeks

Secondary Outcomes (1)

• Biochemical Assessment of Tobacco Use Via Quantitative Urine Screens to Detect Cotinine Level

  Through study completion, an average of 8 weeks

Study Arms (2)

Real TBS to the vmPFC

EXPERIMENTAL

Ten sessions of real Theta Burst Stimulation (TBS) will be delivered to the medial prefrontal cortex (mPFC)

Device: Real TBS to the vmPFC

Sham TBS to the vmPFC

SHAM COMPARATOR

Ten sessions of sham Theta Burst Stimulation (TBS) will be delivered to the medial prefrontal cortex (mPFC)

Device: Sham cTBS to the vmPFC

Interventions

Real TBS to the vmPFC DEVICE

This will be delivered with the Magventure Magpro system; active sham coil (double blinded)

Real TBS to the vmPFC

Sham cTBS to the vmPFC DEVICE

The MagVenture MagPro system has an integrated active sham that uses two surface electrodes placed on the skin beneath the coil.

Sham TBS to the vmPFC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 (to maximize participation, and minimize effects of cortical atrophy on neuroimaging data)
• Current cigarette smoker (at least 10 cigarettes per day).
• 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 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.
• Has current suicidal ideation or homicidal ideation.
• Has the need for acute treatment with any psychoactive medication including anti-seizure medications and medications for attention-deficit/ hyperactivity disorder.
• 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.
• Does not have a stable phone number for contact through calling and/or texting.
• Does not have a stable means of using WebEx (e.g. personal computer, Internet) for interaction with study personnel during COVID-19.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Virginia Tech Carilion School of Medicine and Research Institute: collaborator

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Merideth Addicott, PhD
• Organization: Wake Forest University School of Medicine

maddicot@wakehealth.edu

336-716-7792

Study Officials

• Merideth A. Addicott, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 12, 2019
• Study Start: August 20, 2020
• Primary Completion: November 23, 2022
• Study Completion: November 23, 2022
• Last Updated: May 21, 2024
• Results First Posted: May 21, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)