tDCS + Mindfulness for Smoking Cessation

Overseen By Hilary R Smith

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Smoking cessation

Disqualifiers: Suicidal ideation, Seizure disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people quit smoking using Transcranial Direct Current Stimulation (tDCS), which applies a mild electrical current to the brain, combined with mindfulness practices. The researchers aim to determine if this combination can reduce distress and cigarette use. Participants will receive either active tDCS or a placebo version (sham) paired with mindfulness. This trial may suit those who smoke at least five cigarettes a day, wish to quit soon, and experience mild to moderate distress. As an unphased trial, it offers a unique opportunity to explore innovative treatments for smoking cessation.

Will I have to stop taking my current medications?

The trial requires that your prescription medications have been stable for at least 1 month before joining and remain stable throughout the trial, with approval from the Study Physician. You cannot be using smoking cessation medications.

What prior data suggests that Transcranial Direct Current Stimulation (tDCS) is safe for smoking cessation?

Research shows that Transcranial Direct Current Stimulation (tDCS) is generally safe. In past studies, participants reported no major side effects, experiencing only mild sensations like tingling on the scalp. Some studies found that tDCS helped reduce cigarette smoking in the short term, but its long-term effects remain uncertain.

Despite mixed results on its effectiveness for quitting smoking, the treatment is considered safe. No studies reported serious side effects, making it a relatively safe option for those considering joining a trial like this. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of Transcranial Direct Current Stimulation (tDCS) with mindfulness for smoking cessation because it represents a novel approach to tackling nicotine addiction. Unlike traditional methods such as nicotine replacement therapy or medications like varenicline, tDCS uses a non-invasive electrical current to potentially alter brain activity related to cravings and addiction. This method, paired with mindfulness, which is known to enhance self-control and awareness, could offer a powerful dual approach to quitting smoking. By targeting both the brain's electrical activity and psychological resilience, this treatment has the potential to provide an innovative and effective alternative for smokers seeking to quit.

What evidence suggests that this trial's treatments could be effective for smoking cessation?

Research has shown that transcranial direct current stimulation (tDCS) can help reduce cigarette cravings and smoking. One study demonstrated that applying tDCS to the brain's decision-making area, the DLPFC, led to reduced cigarette use. Another study found that participants who received tDCS were more likely to quit smoking for 30 days compared to those who did not receive the treatment. In contrast, results for using mindfulness to quit smoking are mixed. Some research suggests it helps weaken the connection between craving and smoking, while other studies do not show a clear benefit. This trial will compare two approaches: one group will receive active tDCS combined with mindfulness, while another group will receive sham tDCS combined with mindfulness. Combining tDCS and mindfulness might offer a promising way to help people smoke less. ^{6 7 8 9 10}

Who Is on the Research Team?

Merideth A Addicott, Ph.D.

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for individuals aged 21-75 who smoke at least 10 cigarettes daily, experience mild to moderate distress, and have stable internet access. Participants must not be using smoking cessation meds or inhaled products other than cigarettes, nor have a history of seizures, brain injuries, or metal objects in the head/neck.

Inclusion Criteria

Mild to moderate distress (K10 scores 10-35)

Access to a reliable internet connection

Smoke at least 10 cigarettes per day

Exclusion Criteria

I use inhaled products like vaping or smoking cannabis.

I am currently using medication to help me stop smoking.

I am currently having thoughts about harming myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DLPFC Transcranial Direct Current Stimulation (tDCS) to decrease distress and cigarette smoking

4 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness
• Sham - Transcranial Direct Current Stimulation (tDCS)
• Transcranial Direct Current Stimulation (tDCS)

Trial Overview The study tests if Transcranial Direct Current Stimulation (tDCS) can help reduce cigarette smoking and distress. It involves mindfulness practices and either real tDCS or a sham procedure as control. The participants will be randomly assigned to one of these interventions.

How Is the Trial Designed?

Group I: Active tDCS + Mindfulness Experimental Treatment 2 Interventions

Group II: Sham tDCS + Mindfulness Placebo Group 2 Interventions

Transcranial Direct Current Stimulation (tDCS) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Transcranial Direct Current Stimulation for:

• Depression
• Stroke rehabilitation
• Chronic pain management
• Research use for various neurological and psychiatric conditions including autism spectrum disorder

Approved in European Union as Transcranial Direct Current Stimulation for:

• Depression
• Stroke rehabilitation
• Chronic pain management
• Research use for various neurological and psychiatric conditions including autism spectrum disorder

Approved in Canada as Transcranial Direct Current Stimulation for:

• Depression
• Stroke rehabilitation
• Chronic pain management
• Research use for various neurological and psychiatric conditions including autism spectrum disorder

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

In a study involving 210 tobacco-dependent male participants, transcranial Direct Current Stimulation (tDCS) for 12 weeks showed a 25.7% abstinence rate, comparable to the 20% rate achieved with bupropion, suggesting tDCS could be an effective alternative for smoking cessation.

Participants receiving tDCS had lower nicotine dependency scores compared to those treated with bupropion, indicating that tDCS may not only help with quitting smoking but also reduce the level of addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of transcranial direct current stimulation compared to standard bupropion for the treatment of tobacco dependence: A randomized sham-controlled trial. Ghorbani Behnam, S., Mousavi, SA., Emamian, MH.[2020]

Anodal transcranial direct current stimulation (tDCS) applied to the right dorsolateral prefrontal cortex (R-DLPFC) enhanced functional connectivity between the R-DLPFC and the anterior cingulate cortex, which may improve decision-making and inhibition in smokers.

The study found that tDCS can suppress activity in certain brain areas, like the precuneus, during tasks, indicating that the effects of tDCS can vary based on the specific brain region targeted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of smoker brain activity and functional connectivity by tDCS: A go/no-go task-state fMRI study. Lu, J., Wu, Z., Zeng, F., et al.[2023]

In a study involving 24 participants, transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) significantly reduced cue-provoked smoking cravings compared to sham stimulation, indicating its potential efficacy in smoking cessation.

The study found no significant mood changes or serious adverse events associated with tDCS, suggesting that this noninvasive brain stimulation technique is safe for reducing cravings in smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cortical stimulation of the prefrontal cortex with transcranial direct current stimulation reduces cue-provoked smoking craving: a randomized, sham-controlled study. Fregni, F., Liguori, P., Fecteau, S., et al.[2022]

In a study involving 22 participants, three sessions of transcranial direct current stimulation (tDCS) over the dorsolateral prefrontal cortex (DLPFC) did not show significant differences in cigarette smoking reduction compared to a sham treatment, both in the short term (8 days) and long term (4 months).

While there was a temporary reduction in the number of cigarettes smoked shortly after the tDCS sessions, this effect was not sustained, indicating that tDCS may not be an effective long-term intervention for reducing smoking behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of transcranial direct current stimulation on the number of smoked cigarettes in tobacco smokers. Alghamdi, F., Alhussien, A., Alohali, M., et al.[2023]

Transcranial direct current stimulation (tDCS) applied to the dorsolateral prefrontal cortex (DLPFC) significantly reduced cigarette craving by about 50% in a study of 20 smokers, indicating its potential as a treatment for smoking addiction.

While the number of cigarettes smoked did not change, the study suggests that tDCS may be more effective for smokers with higher nicotine dependence and motivation to quit, highlighting the need for further research in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation of the prefrontal cortex reduces cigarette craving in not motivated to quit smokers: A randomized, sham-controlled study. Perri, RL., Perrotta, D.[2021]

In a randomized sham-controlled trial involving 44 participants, both active and sham tDCS groups showed a significant decrease in daily cigarette consumption and craving, but there were no improvements in executive functions, indicating that the effects may not be due to the stimulation itself.

The study suggests that high perceived stress and low self-control may predict successful reductions in cigarette consumption, highlighting the potential influence of psychological factors over the effects of tDCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of perceived stress and self-control on efficacy of repeated transcranial direct current stimulation in non-treatment-seeking smokers. Müller, T., Shevchenko, Y., Gerhardt, S., et al.[2021]

Transcranial direct current stimulation (tDCS) significantly reduced negative affect in overnight abstinent smokers, as evidenced by lower scores on the Profile of Mood States (POMS) after real tDCS compared to sham stimulation.

While tDCS showed promise in improving mood, it did not significantly affect cigarette craving or attention, indicating that while it is safe and may help with negative emotions, its overall efficacy in treating tobacco dependence needs further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation reduces negative affect but not cigarette craving in overnight abstinent smokers. Xu, J., Fregni, F., Brody, AL., et al.[2021]

This study investigates the effectiveness of transcranial Direct Current Stimulation (tDCS) combined with varenicline for smoking cessation in a double-blind, sham-controlled trial involving 50 healthy smokers over a 12-week treatment period.

The primary goal is to determine if active tDCS can improve 30-day continuous abstinence rates compared to sham tDCS, while also using MRI scans to explore potential changes in brain structure and function related to addiction treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active versus sham transcranial direct current stimulation (tDCS) as an adjunct to varenicline treatment for smoking cessation: Study protocol for a double-blind single dummy randomized controlled trial. Zawertailo, L., Zhang, H., Rahmani, N., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01982110

A Mindfulness Based Application for Smoking Cessation Mindfulness therapy has been found to be effective in teaching strategies to decouple the association between craving and smoking. Mindfulness based smoking ...

2. journals.sagepub.com journals.sagepub.com/doi/10.1177/13591053251371955

Mindfulness-based interventions for smoking cessation in ... The primary outcome was smoking cessation at 6 months or longer. MBIs showed significantly higher odds of smoking cessation than comparators (OR ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9379793/

Mindfulness-Based Smoking Cessation Delivered Through ... The primary outcomes are biochemically verified smoking abstinence at 8, 12, and 24 weeks after the start of treatment. Secondary outcomes include the frequency ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9009295/

Mindfulness for smoking cessation - PMC - PubMed Central We did not detect a clear benefit of mindfulness‐based smoking cessation interventions for increasing smoking quit rates or changing mental health and well‐ ...

5. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD013696.pub2/full

Mindfulness for smoking cessation - Jackson, S - 2022 We did not detect a clear benefit of mindfulness‐based smoking cessation interventions for increasing smoking quit rates or changing mental ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6375608/

Effect of transcranial direct current stimulation on the number ... We found that 3 tDCS sessions significantly reduced cigarette smoking in a short period following stimulation in the active as well as in the ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772392523000202

Brain stimulation therapeutics Three studies failed to find an effect of tDCS on cravings. No tDCS studies reported changing quitting rates in people who smoke. Despite the early positive ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01710410

Transcranial Direct Current Stimulation in a Smoking ... A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...

9. link.springer.com link.springer.com/article/10.1007/s00406-023-01705-8

a randomized double-blind clinical trial The present study found no significant difference in smoking cessation rate between the sham and active tDCS groups, indicating that tDCS ...

10. neuroregulation.org neuroregulation.org/article/view/23465

Focus on the Number of Sessions and Motivation to Quit tDCS helps to reduce tobacco consumption and craving, but its benefits are not maintained over time. It would be necessary to increase the number of sessions ...