Accelerated dTMS Smoking Cessation

Phase 2RecruitingNCT07292883

Waypoint Centre for Mental Health Care40 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tobacco Use Disorder Addiction Nicotine

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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.

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.

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

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.

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.

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.

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.

Change in Daily Cigarette Use (Number of Cigarettes per Day)

This outcome will examine changes in self-reported cigarette consumption using the Timeline Follow Back method from baseline through follow-ups (week 3, 5, 9, 13) to the end of the study (week 26).

Time frame: From baseline to week 26.

Accelerated dTMS Smoking Cessation

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts