Deep Transcranial Magnetic Stimulation for Stimulants Use Disorder

NCT ID: NCT05274828

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-02
• Study Completion Date: 2024-04-01

Brief Summary

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).

Detailed 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.

Conditions

Stimulants Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

H7-Coil Deep TMS Treatment

H7-Coil Deep TMS Treatment

Group Type: EXPERIMENTAL

H7-Coil Deep TMS for CUD

Intervention Type: DEVICE

The Study group will receive dTMS treatment three times a day for ten days.

Interventions

H7-Coil Deep TMS for CUD

The Study group will receive dTMS treatment three times a day for ten days.

Intervention Type: DEVICE

Other Intervention Names

H7-Coil Deep TMS Treatment

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Philippe Miron, MD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

21.358

Identifier Type: -

Identifier Source: org_study_id