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

Qualifiers

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

Treatments tested in this trial

  • Bilateral deep accelerated repetitive transcranial magnetic stimulation

Treatment groups

40 Participants
are divided into 1 treatment group