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| Name | Class |
|---|---|
| Virginia Tech Carilion School of Medicine and Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real TBS to the vmPFC | Experimental | Ten sessions of real Theta Burst Stimulation (TBS) will be delivered to the medial prefrontal cortex (mPFC) |
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| Sham TBS to the vmPFC | Sham Comparator | Ten sessions of sham Theta Burst Stimulation (TBS) will be delivered to the medial prefrontal cortex (mPFC) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real TBS to the vmPFC | Device | This will be delivered with the Magventure Magpro system; active sham coil (double blinded) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merideth A. Addicott, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | United States |
No individual participant data will be shared. All data is de-identified.
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| ID | Title | Description |
|---|---|---|
| FG000 | Real TBS to the vmPFC | Ten sessions of real Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC) Real TBS to the vmPFC: This will be delivered with the Magventure Magpro system; active sham coil (double blinded) |
| FG001 | Sham TBS to the vmPFC |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2022 |
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| 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. |
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Ten sessions of sham Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC) Sham cTBS to the vmPFC: The MagVenture MagPro system has an integrated active sham that uses two surface electrodes placed on the skin beneath the coil. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Real TBS to the vmPFC | Ten sessions of real Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC) Real TBS to the vmPFC: This will be delivered with the Magventure Magpro system; active sham coil (double blinded) |
| BG001 | Sham TBS to the vmPFC | Ten sessions of sham Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC) Sham cTBS to the vmPFC: The MagVenture MagPro system has an integrated active sham that uses two surface electrodes placed on the skin beneath the coil. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | units on a scale | Through study completion, an average of 8 weeks |
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| Primary | 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. | Posted | Mean | Standard Deviation | number of cigarettes per day | Through study completion, an average of 8 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | ng/ml | Through study completion, an average of 8 weeks |
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2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Real TBS to the vmPFC | Ten sessions of real Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC) Real TBS to the vmPFC: This will be delivered with the Magventure Magpro system; active sham coil (double blinded) | 0 | 25 | 0 | 25 | 1 | 25 |
| EG001 | Sham TBS to the vmPFC | Ten sessions of sham Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC) Sham cTBS to the vmPFC: The MagVenture MagPro system has an integrated active sham that uses two surface electrodes placed on the skin beneath the coil. | 0 | 13 | 0 | 13 | 2 | 13 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | General disorders | Non-systematic Assessment |
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| drooping eyelid | General disorders | Non-systematic Assessment |
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| memory problem | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merideth Addicott, PhD | Wake Forest University School of Medicine | 336-716-7792 | maddicot@wakehealth.edu |
| Mar 28, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 15, 2021 | Mar 17, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| D016739 | Behavior, Addictive |
| D014029 | Tobacco Use Disorder |
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000073869 | Tobacco Smoking |
| D064424 | Tobacco Use |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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