Deep Transcranial Magnetic Stimulation for Stimulants Use Disorder

Feasibility Study on the Use of an Intensive Deep Transcranial Magnetic Stimulation Protocol in the Treatment of Cocaine and Other Stimulants Use Disorder

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).

Study Overview

• Status: Completed
• Conditions: Stimulants Use Disorder
• Intervention / Treatment: Device: H7-Coil Deep TMS for CUD

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 3J4
      • Centre Hospitalier de l'Universite de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: H7-Coil Deep TMS Treatment	Device: H7-Coil Deep TMS for CUD; The Study group will receive dTMS treatment three times a day for ten days.; Other Names: H7-Coil Deep TMS Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility-related endpoints - adherence to dTMS	Number of completer treatment sessions	after 10 days of treatment sessions
Feasibility-related endpoints - retention rates	Number of patients who did not completed the total (40) sessions	after 10 days of treatment sessions
Adverse Events reported	Adverse events reported	up to three months after end of the treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Positive Urine Drug Screen to Stimulants	Presence of Stimulants in the Drug Screen Panel	up to three months after end of the treatment
Percentage change on Stimulants Craving Questionnaire	Percentage change on Stimulants Craving Questionnaire	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)	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)	T0 (week 0), T2 (week 4), T3 (week 6), T4 (week 14)
Percentage change on General Anxiety Disorder (GAD-7)	Percentage change on General Anxiety Disorder (GAD-7)	T0 (week 0), T2 (week 4), T3 (week 6), T4 (week 14)

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Jean-Philippe Miron, MD, Centre Hospitalier de l'Universite de Montreal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: 21.358

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No