The Use of tDCS for Vaping Reduction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCentre for Addiction and Mental Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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*
Trial design
Design model
Parallel
Treatments tested in this trial
Active tDCS
DeviceTranscranial 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 tDCS
DeviceSham 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Active tDCS stimulation groupActive comparator 1 intervention
Group B: Sham tDCS stimulation groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Explore the efficacy of tDCS for reducing vaping use.
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).
Time frame
2 weeksSecondary outcomes
1
Explore changes in craving that are associated with tDCS intervention.
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.
Time frame
2 weeksSponsors and contacts
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Source ClinicalTrials.gov