Stimulants Use Disorder Clinical Trial
Official title:
Feasibility Study on the Use of an Intensive Deep Transcranial Magnetic Stimulation Protocol in the Treatment of Cocaine and Other Stimulants Use Disorder
NCT number | NCT05274828 |
Other study ID # | 21.358 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2, 2022 |
Est. completion date | April 1, 2024 |
Verified date | April 2024 |
Source | Centre hospitalier de l'Université de Montréal (CHUM) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 15 |
Est. completion date | April 1, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Canada | Centre Hospitalier de l'Université de Montréal | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de l'Université de Montréal (CHUM) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility-related endpoints - adherence to dTMS | Number of completer treatment sessions | after 10 days of treatment sessions | |
Primary | Feasibility-related endpoints - retention rates | Number of patients who did not completed the total (40) sessions | after 10 days of treatment sessions | |
Primary | Adverse Events reported | Adverse events reported | up to three months after end of the treatment | |
Secondary | 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 | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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