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Completed

NCT Number: NCT05274828

Deep Transcranial Magnetic Stimulation for 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).

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3J4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

H7-Coil Deep TMS for CUD

Device

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

Other names: H7-Coil Deep TMS Treatment

Primary outcomes

  1. Feasibility-related endpoints - adherence to dTMS

    Time frame: after 10 days of treatment sessions

    Number of completer treatment sessions

  2. Feasibility-related endpoints - retention rates

    Time frame: after 10 days of treatment sessions

    Number of patients who did not completed the total (40) sessions

  3. Adverse Events reported

    Time frame: up to three months after end of the treatment

    Adverse events reported

Secondary outcomes

  1. Percentage of Positive Urine Drug Screen to Stimulants

    Time frame: up to three months after end of the treatment

    Presence of Stimulants in the Drug Screen Panel

  2. 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 Craving Questionnaire

  3. Percentage change on Stimulants Selective Severity Assessment

    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 (Minimum score 0 and Maximum score 126, higher score means worse outcome in terms of substance withdrawal symptoms)

  4. Percentage change on Patient Health Questionnaire (PHQ-9)

    Time frame: T0 (week 0), T2 (week 4), T3 (week 6), T4 (week 14)

    Percentage change on Patient Health Questionnaire (PHQ-9)

  5. Percentage change on General Anxiety Disorder (GAD-7)

    Time frame: T0 (week 0), T2 (week 4), T3 (week 6), T4 (week 14)

    Percentage change on General Anxiety Disorder (GAD-7)

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 11, 2022
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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