Deep Transcranial Magnetic Stimulation for Stimulants Use Disorder

Centre hospitalier de l'Université de Montréal (CHUM)

Status

Completed

Conditions

Stimulants Use Disorder

Treatments

Device: H7-Coil Deep TMS for CUD

Study type

Interventional

Funder types

Other

Identifiers

NCT05274828

21.358

Details and patient eligibility

About

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).

Full description

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.

Enrollment

15 patients

Sex

All

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Being diagnosed with SUD (moderate or severe) based on DSM-5 criteria
Current stimulants use with last use in the two weeks prior to admission to the study as confirmed by the Timeline Followback Questionnaire
Wanting to stop the intake of stimulants
Being able and willing to adhere to the treatment schedule
Filling the criteria of the TMS adult safety screening (TASS) questionnaire
Being voluntary and competent to consent to treatment
Ability to speak and read French or English

Exclusion criteria

Severe psychiatric condition (history of schizophrenia, schizoaffective disorder or bipolar disorder); current acute psychosis, mania or active suicidality (unipolar major depression, anxiety disorders and personality disorders will be allowed as long as they are not primary and causing greater impairment than SUD)
Severe and/or unstable medical illness, including but not limited to any neurologic, cardiac, renal or hepatic condition
Implanted medical device (including but not limited to intracranial implants, cardiac pacemaker, medication pump, etc.) or intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
Clinically significant laboratory abnormality, in the opinion of the principal investigator
Pregnancy or breastfeeding
Another current severe substance use disorder (except nicotine)
Anti-craving medication and other psychotropic medications are allowed, but need to have been stable for four (4) weeks before screening
Currently taking more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit TMS efficacy.
Non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with the interview)