Stimulants Use Disorder
Conditions
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.
Interventions
DEVICEH7-Coil Deep TMS for CUD
The Study group will receive dTMS treatment three times a day for ten days.
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility-related endpoints - adherence to dTMS | after 10 days of treatment sessions | Number of completer treatment sessions |
| Feasibility-related endpoints - retention rates | after 10 days of treatment sessions | Number of patients who did not completed the total (40) sessions |
| Adverse Events reported | up to three months after end of the treatment | Adverse events reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change on Patient Health Questionnaire (PHQ-9) | T0 (week 0), T2 (week 4), T3 (week 6), T4 (week 14) | Percentage change on Patient Health Questionnaire (PHQ-9) |
| Percentage of Positive Urine Drug Screen to Stimulants | up to three months after end of the treatment | Presence of Stimulants in the Drug Screen Panel |
| Percentage change on General Anxiety Disorder (GAD-7) | T0 (week 0), T2 (week 4), T3 (week 6), T4 (week 14) | Percentage change on General Anxiety Disorder (GAD-7) |
| 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 Craving Questionnaire |
| Percentage change on Stimulants Selective Severity Assessment | 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) |
Countries
Canada
Outcome results
None listed