Accelerated dTMS Smoking Cessation

Waypoint Centre for Mental Health Care

Status and phase: Not yet enrolling; Phase 2

Conditions: Addiction Nicotine; Tobacco Use Disorder

Treatments: Device: Bilateral deep accelerated repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07292883

5240

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Accelerated Repetitive Transcranial Magnetic Stimulation

Experimental group

Description:

Bilateral Accelerated Repetitive Transcranial Magnetic Stimulation targeting the insula and prefrontal cortex using H4 coil

Treatment:

Device: Bilateral deep accelerated repetitive transcranial magnetic stimulation