Conditions:
Tobacco Use Disorder
Addiction Nicotine
Sponsor: Waypoint Centre for Mental Health Care
trial.available_in:
БГ
Overview
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.
Who can participate
Inclusion Criteria:
1. Aged 18 years or older;
2. Tobacco use disorder as assessed by DSM-5;
3. Fagerstrom Test of Nicotine Dependence (FTND) ≥ 4;
4. Reported motivation to quit within 30 days as assessed using the Contemplation Ladder score of ≥ 7;
5. Must sign and date the informed consent form;
6. Stated willingness to comply with all study procedures.
7. Able to communicate in English.
Exclusion Criteria:
1. Reported smoking abstinence in the 3 months preceding screening visit;
2. Current use of other smoking cessation aids;
3. Contraindication to rTMS;
4. Pregnancy, trying to become pregnant or breastfeeding;
5. Current or recent history of cerebrovascular disease;
6. Unstable major psychiatric disorder(s) (i.e. Axis I Disorders) that would prevent participation in the study at PI (or its delegate) discretion;
7. Serious current or personal history of medical condition/disease (neurological disorders, brain lesions, multiple sclerosis, head trauma, loss of consciousness, hearing loss, etc.) preventing same inclusion as per PI (or its delegate) discretion;
8. Current, personal history or family history of seizures;
9. Concomitant use of medication that lowers seizure threshold, such as clozapine;
10. Concomitant use of more than 2 mg lorazepam (or an equivalent) or any anticonvulsants.
Interventions
Bilateral deep accelerated repetitive transcranial magnetic stimulation