Status:
COMPLETED
Deep Transcranial Magnetic Stimulation for Stimulants Use Disorder
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
Stimulants Use Disorder
Eligibility:
All Genders
21-65 years
Phase:
NA
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 patien...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05274828
Start Date
November 2 2022
End Date
April 1 2024
Last Update
April 17 2024
Active Locations (1)
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1
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X 3J4