- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06885606
The Use of tDCS for Vaping Reduction
Using Transcranial Direct Current Stimulation (tDCS) for Vaping Reduction in Daily E-cigarette Users: a Pilot Study
Project Summary - tDCS for Vaping Reduction
Background: While the prevalence of tobacco smoking has plateaued over the last several years, the prevalence of nicotine vaping (e-cigarettes) continues to increase exponentially in Canada. Originally touted as a safe alternative to smoking, e-cigarette use or vaping is now most popular among youth and young adults. The high prevalence of e-cigarette use, coupled with growing evidence of associated harms and reports of addiction and difficulties in quitting reinforces the urgent need to develop and test methods to attenuate e-cigarette craving as a step towards developing approaches to vaping cessation that are brief, inexpensive and effective. Non-invasive brain stimulation techniques have become a popular area of research as a treatment option for substance use disorders with growing evidence of their effectiveness for a variety of addictions. One of these techniques, transcranial direct current stimulation (tDCS), has been shown to decrease cigarette craving and consumption. Thus, the purpose of this pilot study is to evaluate the effectiveness of using tDCS for vaping reduction in e-cigarette users.
Methods: This will be a double-blind sham-controlled randomized trial whereby 40 daily nicotine-containing e-cigarette users will be recruited to undergo 10 consecutive daily sessions of tDCS (Monday to Friday for 2 weeks). Participants will be randomized (1:1) to either sham (0mA) or active tDCS (2mA), with the anode at the left dorsolateral prefrontal cortex (DLPFC) and cathode at the right DLPFC. The primary outcome is vaping frequency (puffs/day and nicotine pods/week) at end of treatment (2 weeks). The secondary outcome will be e-cigarette craving. Participants will be followed-up via the phone at 1 month and 3 months post randomization respectively.
Implication: This will be the first treatment study to target vaping reduction. There are currently no established treatment options for e-cigarette addiction and medications traditionally used for smoking cessation only address withdrawal symptoms and not addiction pathology. Thus, findings from this study may be used to inform future designs of vaping reduction strategies or vaping cessation.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eunice Chen, M.Sc.
- Phone Number: 77283 (416) 535-8501
- Email: yixuan.chen@camh.ca
Study Contact Backup
- Name: Kameron Iturralde, B.Sc.
- Phone Number: 77293 (416) 535-8501
- Email: Kameron.Iturralde@camh.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M6J 1H4
- Recruiting
- Centre for Addiction and Mental Health
-
Principal Investigator:
- Laurie Zawertailo, PhD
-
Contact:
- Laurie A ZAWERTAILO, PhD
- Phone Number: 4166667395
- Email: laurie.zawertailo@camh.ca
-
Contact:
- Eunice Chen, MSc
- Phone Number: 77422 416-535-8501
- Email: yixuan.chen@camh.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
The participant must meet all of the inclusion criteria to be eligible for this research study:
- Be able to provide informed written consent
- Stated willingness to comply with all study procedures
- Age 18 - 65 years
- Is a daily regular use of nicotine-containing e-cigarette for at least the past 6 months
- Is willing to attend daily appointments for tDCS for two consecutive weeks (Monday through Friday)
- Is not interested in or planning to quit vaping in the next 30 days.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this research study:
- Substance use disorder (other than nicotine dependence) (M.I.N.I. SCID) (confirmed with urine drug screen)
- Current regular use of tobacco cigarettes, nicotine replacement therapy or other medications for smoking cessation
- Unstable psychiatric condition
- Recent clinically significant head trauma*
- History of seizures and/or epilepsy*
- Pacemakers or implanted electrical devices such as cochlear implants*
- Metal embedded in the skull*
- Skin lesions, open wounds, bruising, or similar injuries on the scalp*
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Active tDCS stimulation group
|
Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation that involves brief (e.g., 20-min) application of weak electric current (e.g., 2 mA) to the scalp.
Active tDCS intervention increases excitability of neurons at the anode with 20-30% of the current going through the brain from anode to cathode so that both cortical and subcortical structures are stimulated.
The procedure is very safe, convenient, and fast-acting with well-established parameters.
It has the ability to modulate plasticity in specific brain areas and has established efficacy in human laboratory models of addictive motivation and has been shown to decrease craving for cigarettes when the anode is placed over the left dorsolateral prefrontal cortex (DLPFC).
|
|
Sham Comparator: Sham tDCS stimulation group
Sham tDCS applies a 2mA current for the initial 30 seconds, followed by 0 mA for the remaining 19.5 minutes to simulate active tDCS stimulation.
The cathode electrode is placed on the right dorsolateral prefrontal cortex (DLPFC), and the anode is positioned on the left DLPFC, aligned with the electrode placement used in active tDCS.
|
Sham tDCS applies a 2mA current for the initial 30 seconds, followed by 0 mA for the remaining 19.5 minutes to simulate active tDCS stimulation.
The cathode electrode is placed on the right dorsolateral prefrontal cortex (DLPFC), and the anode is positioned on the left DLPFC, aligned with the electrode placement used in active tDCS.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Explore the efficacy of tDCS for reducing vaping use.
Time Frame: 2 weeks
|
The primary outcome is frequency of vape use at end of treatment (2 week period), measured by self-reported vaping frequency (puffs/day) and nicotine pods/week (estimate total nicotine consumed per week).
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Explore changes in craving that are associated with tDCS intervention.
Time Frame: 2 weeks
|
The secondary outcome of this study will be e-cigarette craving at end of treatment (2 week period), as well as vaping use at 3 months follow up.
|
2 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 007/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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