The purpose of the study is to explore the Feasibility, Tolerability and Safety of the H7-Coil deep Transcranial Magnetic Stimulation for Subjects with Stimulants Use Disorder (SUD).
Stimulants Use Disorder (SUD) is a major public health issue, with potentially severe psychosocial and medical consequences. Even though psychosocial therapies exist, an important proportion of patients do not respond to these approaches, and no approved biological approaches are currently available. deep TMS (dTMS) has been shown effective for Major Depressive Disorder, Obsessive Compulsive Disorder and Nicotine Use Disorder and could also prove available for SUD. Several pilot studies have shown preliminary effectiveness in SUD, but are limited by the length of their protocol, which could result in limited real-world effectiveness secondary to high dropout rates. Given that aTMS protocols have been applied successfully in MDD, we propose to implement this approach for SUD, in order to reduce treatment length and therefore increase retention rates. We will also gather preliminary data on various biomarkers that could help predict response and better understand biological mechanisms behind SUD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
The Study group will receive dTMS treatment three times a day for ten days.
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Feasibility-related endpoints - adherence to dTMS
Number of completer treatment sessions
Time frame: after 10 days of treatment sessions
Feasibility-related endpoints - retention rates
Number of patients who did not completed the total (40) sessions
Time frame: after 10 days of treatment sessions
Adverse Events reported
Adverse events reported
Time frame: up to three months after end of the treatment
Percentage of Positive Urine Drug Screen to Stimulants
Presence of Stimulants in the Drug Screen Panel
Time frame: up to three months after end of the treatment
Percentage change on Stimulants Craving Questionnaire
Percentage change on Stimulants Craving Questionnaire
Time frame: T0 (week 0), T1 (end of treatment, week 2), T2 (week 4), T3 (week 6), T4 (week 14)
Percentage change on Stimulants Selective Severity Assessment
Percentage change on Stimulants Selective Severity Assessment (Minimum score 0 and Maximum score 126, higher score means worse outcome in terms of substance withdrawal symptoms)
Time frame: T0 (week 0), T1 (end of treatment, week 2), T2 (week 4), T3 (week 6), T4 (week 14)
Percentage change on Patient Health Questionnaire (PHQ-9)
Percentage change on Patient Health Questionnaire (PHQ-9)
Time frame: T0 (week 0), T2 (week 4), T3 (week 6), T4 (week 14)
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Percentage change on General Anxiety Disorder (GAD-7)
Percentage change on General Anxiety Disorder (GAD-7)
Time frame: T0 (week 0), T2 (week 4), T3 (week 6), T4 (week 14)