N/A
Completed N=16
Effect of a Non-Invasive Brain Stimulation Technique on Smoking Cessation Behaviors
Source: ClinicalTrials.gov NCT03386253 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: Number of Participants Willing to Complete 5 Days of tDCS or Sham — 7; 8 Participants
Summary
In this pilot study, the feasibility of using tDCS (a non-invasive brain stimulation technique) while performing a task requiring cognitive flexibility will be examined in smokers and initial data will be collected regarding the effect of tDCS on smoking cessation behaviors. Smokers will be randomized to receive either active or sham tDCS daily for 5 days after which they will attempt to quit smoking. Smoking behavior after the attempted quit date will be assessed at four weekly visits.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Willing to Complete 5 Days of tDCS or Sham |
7; 8 | — |
| SECONDARY Change in Number of Cigarettes Smoked Per Day |
-4.03; -4.47 | 0.77 |
Eligibility Criteria
Inclusion Criteria
- Be between the ages of 18 and 64
- Smoked (on average) at least 5 cigarettes per day
- Be motivated to quit smoking
Exclusion Criteria
- Unstable medical or psychiatric conditions
- Any medical conditions with neurological sequelae
- History of loss of consciousness of greater than 30 minutes duration or loss of consciousness with neurological sequelae
- Have any medical condition or use any medication that would either increase risk of subjects participating in this study (e.g., medications that lower the seizure threshold) or that would impact measures of interest (e.g. smoking cessation medications).
- Are pregnant or planning to become pregnant during the study
- Current use of pacemaker, intracranial electrodes or implanted defibrillator
Data sourced from ClinicalTrials.gov (NCT03386253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.