SmokingNCT04159571
QuitFast: Evaluating Transcranial Magnetic Stimulation as a Tool to Reduce Smoking Directly Following a Quit Attempt
A study testing Real TBS to the vmPFC in people with Smoking and Smoking Cessation, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Smoking, Smoking Cessation, Craving
- What is being tested?
- Real TBS to the vmPFC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2020to 23 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
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.
Read the detailed description
The investigators will evaluate the efficacy of TMS to the ventromedial prefrontal cortex (vmPFC) to change smoking-related behaviors. The investigators long-term vision is that TBS would be used as an acute intervention enabling individuals to get through the first week after a smoking quit attempt without relapsing, and transition to more sustainable mechanisms of behavioral change (e.g., medication, cognitive behavioral therapy).
Aim 1 (Strategy 1): Modulating the limbic system as an approach to treatment: vmPFC TBS. Cigarette smokers will be randomized to receive 10 days of real TBS or sham TBS directed to the vmPFC. Intermittently the desire to smoke, and cigarette self-administration will be assessed. The investigators hypothesize that TBS will: 1) decrease the behavioral smoking measures described above, which will be sustained over a time period sufficient to overcome the initial quit attempt (~7-14 days).
The outcomes of the present aims will resolve a critical gap in the investigator's knowledge regarding the efficacy of a promising TMS treatment strategies. These outcomes will be directly translated to a larger longitudinal study evaluating a multi-pronged approach to improving outcomes in traditional pharmacotherapy or behavioral treatments.
- Conditions
- Smoking, Smoking Cessation, Craving, Addiction, Addiction Nicotine, Nicotine Dependence
- Being tested
- Real TBS to the vmPFC, Sham cTBS to the vmPFC
- Keywords
- Transcranial Magnetic Stimulation, Brain Stimulation, Treatment, Neuroimaging
- Medical subject headings
- Smoking, Smoking Cessation, Behavior, Addictive, Tobacco Use Disorder, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real TBS to the vmPFCDevice
This will be delivered with the Magventure Magpro system; active sham coil (double blinded)
Sham cTBS to the vmPFCDevice
The MagVenture MagPro system has an integrated active sham that uses two surface electrodes placed on the skin beneath the coil.
| Study group | Role | What they receive |
|---|---|---|
| Real TBS to the vmPFC | Experimental | Ten sessions of real Theta Burst Stimulation (TBS) will be delivered to the medial prefrontal cortex (mPFC) Receives: 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) Receives: Device: Sham cTBS to the vmPFC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Through study completion, an average of 8 weeks
Secondary outcomes (1)
Biochemical Assessment of Tobacco Use Via Quantitative Urine Screens to Detect Cotinine Level
Changes in cigarette use as detected by quantitative cotinine urine screens collected at visits 1, 6, 10, and all follow-ups. Values are averaged across all time points.
Measured: Through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start20 Aug 2020
- Primary completion23 Nov 2022
- Study completion23 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Tech Carilion School of Medicine and Research Institute
- Responsible party
- Sponsor
- Investigators
- Merideth A. Addicott, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159571
- Sponsor's protocol ID
- IRB00061841
- Status last verified
- Apr 2024
- First submitted
- 4 Nov 2019
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No individual participant data will be shared. All data is de-identified.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QuitFast: Evaluating Transcranial Magnetic Stimulation as a Tool to Reduce Smoking Directly Following a Quit Attempt
- ClinicalTrials.gov ID
- NCT04159571
- Acronym / sponsor ID
- IRB00061841
- Conditions
- Smoking, Smoking Cessation, Craving, Addiction, Addiction Nicotine, Nicotine Dependence
- Keywords
- Transcranial Magnetic Stimulation, Brain Stimulation, Treatment, Neuroimaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Virginia Tech Carilion School of Medicine and Research Institute
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Posted 21 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators will evaluate the efficacy of TMS to the ventromedial prefrontal cortex (vmPFC) to change smoking-related behaviors. The investigators long-term vision is that TBS would be used as an acute intervention enabling individuals to get through the first week after a smoking quit attempt without relapsing, and transition to more sustainable mechanisms of behavioral change (e.g., medication, cognitive behavioral therapy).
Aim 1 (Strategy 1): Modulating the limbic system as an approach to treatment: vmPFC TBS. Cigarette smokers will be randomized to receive 10 days of real TBS or sham TBS directed to the vmPFC. Intermittently the desire to smoke, and cigarette self-administration will be assessed. The investigators hypothesize that TBS will: 1) decrease the behavioral smoking measures described above, which will be sustained over a time period sufficient to overcome the initial quit attempt (~7-14 days).
The outcomes of the present aims will resolve a critical gap in the investigator's knowledge regarding the efficacy of a promising TMS treatment strategies. These outcomes will be directly translated to a larger longitudinal study evaluating a multi-pronged approach to improving outcomes in traditional pharmacotherapy or behavioral treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real TBS to the vmPFC | Experimental | Device: Real TBS to the vmPFCTen sessions of real Theta Burst Stimulation (TBS) will be delivered to the medial prefrontal cortex (mPFC) |
| Sham TBS to the vmPFC | Sham comparator | Device: Sham cTBS to the vmPFCTen sessions of sham Theta Burst Stimulation (TBS) will be delivered to the medial prefrontal cortex (mPFC) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real TBS to the vmPFCThis will be delivered with the Magventure Magpro system; active sham coil (double blinded) | Device | Real TBS to the vmPFC |
| Sham cTBS to the vmPFCThe MagVenture MagPro system has an integrated active sham that uses two surface electrodes placed on the skin beneath the coil. | Device | Sham TBS to the vmPFC |
Primary outcome
Questionnaire on Smoking Urges Administered Daily Pre TMS to Measure Craving
Time frame: Through study completion, an average of 8 weeks
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).
Self- Report Assessment of Cigarette 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 cigarettes they've used each day for the past 30 days or since the previous assessment, whichever is fewer.
1 secondary outcome
Biochemical Assessment of Tobacco Use Via Quantitative Urine Screens to Detect Cotinine Level
Time frame: Through study completion, an average of 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No individual participant data will be shared. All data is de-identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merideth A. Addicott, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real TBS to the vmPFC in people with Smoking and Smoking Cessation, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire on Smoking Urges Administered Daily Pre TMS to Measure Craving (time frame: Through study completion, an average of 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.