An interventional study of Real TBS to the vmPFC and Sham cTBS to the vmPFC in Smoking, Smoking Cessation and Craving, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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.
325 studies on the registry are indexed under Smoking; 141 are open to participants now.
This study's enrollment of 40 is below the median of 117 across 250 interventional studies indexed under Smoking.
Browse Smoking studies →Wake Forest University Health Sciences is the lead sponsor of 1,345 studies on the registry; 198 are open to participants now.
Of its 328 completed or terminated interventional studies of FDA-regulated products, 249 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Ten sessions of real Theta Burst Stimulation (TBS) will be delivered to the medial prefrontal cortex (mPFC)
Device: Real TBS to the vmPFC
Ten sessions of sham Theta Burst Stimulation (TBS) will be delivered to the medial prefrontal cortex (mPFC)
Device: Sham cTBS to the vmPFC
This will be delivered with the Magventure Magpro system; active sham coil (double blinded)
The MagVenture MagPro system has an integrated active sham that uses two surface electrodes placed on the skin beneath the coil.
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).
Time frame: 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.
Time frame: Through study completion, an average of 8 weeks
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.
Time frame: Through study completion, an average of 8 weeks
| Milestone | Real TBS to the vmPFC | Sham TBS to the vmPFC |
|---|---|---|
| Started | 26 | 14 |
| Completed | 15 | 8 |
| Not completed | 11 | 6 |
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).
| units on a scale | Real TBS to the vmPFC | Sham TBS to the vmPFC |
|---|---|---|
| Questionnaire on Smoking Urges Administered Daily Pre TMS to Measure Craving | 16 ± 8 | 12 ± 3 |
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.
| number of cigarettes per day | Real TBS to the vmPFC | Sham TBS to the vmPFC |
|---|---|---|
| Self- Report Assessment of Cigarette Use Through Timeline Follow-Back (TLFB) Interview | 10 ± 9 | 12 ± 8 |
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.
| ng/ml | Real TBS to the vmPFC | Sham TBS to the vmPFC |
|---|---|---|
| Biochemical Assessment of Tobacco Use Via Quantitative Urine Screens to Detect Cotinine Level | 1872 ± 1705 | 1374 ± 1079 |
Collected over 2 months. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Real TBS to the vmPFC | 0/25 (0%) | 0/25 (0%) | 1/25 (4%) |
| Sham TBS to the vmPFC | 0/13 (0%) | 0/13 (0%) | 2/13 (15.4%) |
| Event | Real TBS to the vmPFC | Sham TBS to the vmPFC |
|---|---|---|
| drooping eyelidGeneral disorders | 0/25 | 1/13 |
| memory problemGeneral disorders | 0/25 | 1/13 |
| headacheGeneral disorders | 1/25 | 0/13 |
| Age, Continuous(years) | Real TBS to the vmPFC | Sham TBS to the vmPFC | Total |
|---|---|---|---|
| Mean | 56 ± 12 | 54 ± 15 | 55 ± 14 |
| Sex: Female, Male(Participants) | Real TBS to the vmPFC | Sham TBS to the vmPFC | Total |
|---|---|---|---|
| Female | 15 | 7 | 22 |
| Male | 10 | 6 | 16 |
| Race (NIH/OMB)(Participants) | Real TBS to the vmPFC | Sham TBS to the vmPFC | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 7 | 1 | 8 |
| White | 17 | 11 | 28 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Real TBS to the vmPFC | Sham TBS to the vmPFC | Total |
|---|---|---|---|
| United States | 25 | 13 | 38 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — No individual participant data will be shared. All data is de-identified.
Ran from Aug 2020 to primary completion in Nov 2022, 27 months.
Results were first posted in May 2024, 1 year 5 months after primary completion.
Of 141 non-industry interventional studies with no phase under Smoking, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 60. This study's 27 months is below that.
Counting every sponsor, half of 155 studies reached it within 37 months; a quarter within 18 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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