tDCS + Mindfulness for Smoking Cessation

Recruiting in Palo Alto (17 mi)

Overseen by Merideth A Addicott, Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Wake Forest University Health Sciences

Must not be taking: Smoking cessation

Disqualifiers: Suicidal ideation, Seizure disorder, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The study aims to evaluate the feasibility of using Dorsolateral Prefrontal Cortex (DLPFC) Transcranial Direct Current Stimulation (tDCS) as a tool to decreasing distress and cigarette smoking. 46 participants currently smoking cigarettes, and seeking to decrease cigarette use will be recruited.

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 data supports the effectiveness of this treatment for smoking cessation?

Research shows that transcranial direct current stimulation (tDCS) can reduce negative feelings and smoking cravings in some smokers, suggesting it might help with smoking cessation. However, its full effectiveness, especially when combined with mindfulness practices, needs more investigation. ^{1 2 3 4 5}

Is tDCS safe for humans?

Research shows that transcranial direct current stimulation (tDCS) is generally safe for humans, with studies reporting no significant side effects in smokers. It has been used to reduce negative feelings in smokers without causing harm. ^{3 4 6 7 8}

How is the treatment tDCS + Mindfulness for Smoking Cessation different from other treatments for quitting smoking?

The treatment uses transcranial direct current stimulation (tDCS), a non-invasive method that applies a small electrical current to specific brain areas, which may help reduce smoking cravings and cigarette consumption by altering brain activity. This approach is unique compared to standard drug treatments like bupropion, as it directly targets brain function without medication. ^{2 4 5 6 7}

Research Team

Merideth A Addicott, Ph.D.

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Mindfulness (Behavioural Intervention)
• Sham - Transcranial Direct Current Stimulation (tDCS) (Device)
• Transcranial Direct Current Stimulation (tDCS) (Device)

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.

Participant Groups

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 Canada for the following indications:

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+

Dr. L. Ebony Boulware

Wake Forest University Health Sciences

Chief Medical Officer since 2022

MD from Duke University School of Medicine, MPH from Johns Hopkins Bloomberg School of Public Health

Dr. Julie Ann Freischlag

Wake Forest University Health Sciences

Chief Executive Officer since 2020

BS from University of Illinois, MD from Rush University

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Executive Officer since 2003

MD from National Autonomous University of Mexico

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Medical Officer since 2003

MD from National Autonomous University of Mexico

Findings from Research

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]

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 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]

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]

References

1. England 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. [2021]

2. United States 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. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation reduces negative affect but not cigarette craving in overnight abstinent smokers. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Modulation of smoker brain activity and functional connectivity by tDCS: A go/no-go task-state fMRI study. [2023]

5. England 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. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of transcranial direct current stimulation on the number of smoked cigarettes in tobacco smokers. [2023]

7. Ireland 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. [2021]

8. United States 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. [2023]