Accelerated dTMS Smoking Cessation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWaypoint Centre for Mental Health Care
About this trial
The goal of this clinical trial is to examine whether a 5-day course of bilateral accelerated deep transcranial magnetic stimulation (aTMS) is a feasible treatment to help adults (18-65) with Tobacco Use Disorder to quit smoking. This study aims to enroll 30-40 participants and will examine treatment tolerability, treatment acceptability, participant retention, and adherence to scheduled treatment sessions.
There are two key objectives and hypotheses:
Objective 1: To evaluate whether a 1-week course of bilateral aTMS (4 sessions per day for 5 days) is feasible and tolerable as a smoking cessation treatment.
Hypothesis 1: Feasibility will be demonstrated by acceptable tolerability, acceptability, retention, and adherence, with a practical target of 30 out of 40 participants completing the treatment.
Objective 2: To explore how aTMS affects smoking outcomes, including:
* Point-prevalence abstinence at end of treatment and at Weeks 3, 5, and 9. * Prolonged/continuous abstinence at Weeks 13 and 26. * Craving, cigarettes per day, and dependence severity. Hypothesis 2: Participants will show improvements on these outcomes from post-treatment through follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years or older;
Tobacco use disorder as assessed by DSM-5;
Fagerstrom Test of Nicotine Dependence (FTND) ≥ 4;
Reported motivation to quit within 30 days as assessed using the Contemplation Ladder score of ≥ 7;
Disqualifiers
Reported smoking abstinence in the 3 months preceding screening visit;
Current use of other smoking cessation aids;
Contraindication to rTMS;
Pregnancy, trying to become pregnant or breastfeeding;
Trial design
Design model
Single group
Treatments tested in this trial
Bilateral deep accelerated repetitive transcranial magnetic stimulation
DeviceAccelerated Repetitive Transcranial Magnetic Stimulation (aTMS) is a type of treatment that will be used to target the bilateral insular cortex and prefrontal cortex using the Health Canada-approved H4 coil. The purpose is to test its feasibility on smoking abstinence. While convention rTMS methods involves one session daily over several weeks, aTMS delivers multiple sessions per day. Using the H4 deep aTMS, this study will implement 20 sessions over five consecutive days (four sessions daily).
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Accelerated Repetitive Transcranial Magnetic StimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants Who Discontinue Accelerated dTMS Due to Side Effects
Tolerability will be assessed by calculating the percentage of participants who discontinue the 5-day accelerated dTMS treatment course due to side effects.
Time frame
From week 1 day 1, to week 1 day 5 of treatment week.2
TMS Experience Questionnaire Acceptability Scores (Units on a Scale)
Acceptability will be assessed using scores on the TMS Experience Questionnaire.
Time frame
From week 1 day 1, to week 1 day 5 of treatment week.3
Percentage of Participants Completing the 5-day Accelerated dTMS Treatment Course
Retention will be measured by the percentage of enrolled participants who complete the full 5-day accelerated dTMS treatment protocol (4 sessions per day for 5 days). The aim is 30 out of 40 participants (75%) completing the course.
Time frame
From week 1 day 1, to week 5 day 5 of treatment week.4
Percentage of Treatment Sessions Attended
Adherence will be measured by calculating the percentages of planned accelerated dTMS treatment sessions attended (20 sessions total over 5 days). For each participant, adherence will be calculated as number of sessions attended divided by 20, and then calculating a mean percentage.
Time frame
From week 1 day 1, to week 1 day 5 of treatment week.Secondary outcomes
1
The percentage of participants achieving continuous short-term abstinence at follow up
Measuring the percentage of participants who achieved 7-day point prevalence abstinence at the end of treatment, week 3, week 5, week 9, week, 13, week 26.
Time frame
From week 1 day 5 of treatment to week 26.2
The percentage of participants achieving continuous long-term abstinence at follow up
Calculating the percentage of participants who achieved prolonged and continuous absence at week 13 (3 months) and week 26 (6 months).
Time frame
From week 1 day 1 of treatment to week 26.3
Change in Tobacco Craving Questionnaire-Short Form (TCQ-SF) Total Score (Units on a Scale)
This outcome will examine changes in self-reported cravings using the TCQ-SF. TCQ-SF total scores will be compared from baseline to the end of treatment (week 26) and across follow-up visits (week 3, 5, 9, 13, 26).
Time frame
From baseline to week 26.4
Change in Dependence Severity (Units on a Scale)
This outcome will examine changes in nicotine dependence severity from baseline to the end of treatment (week 26) and during follow-up visits (week 3, 5, 9, 13) using the Fagerstrom Test for Nicotine Dependence (FTND).
Time frame
From baseline to week 26.Sponsors and contacts
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Source ClinicalTrials.gov