Stimulants Use DisorderNCT05274828
Deep Transcranial Magnetic Stimulation for Stimulants Use Disorder
A study testing H7-Coil Deep TMS for CUD in people with Stimulants Use Disorder, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Stimulants Use Disorder
- What is being tested?
- H7-Coil Deep TMS for CUD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 2 Nov 2022to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3J4
About this study
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
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).
Read the 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.
- Conditions
- Stimulants Use Disorder
- Being tested
- H7-Coil Deep TMS for CUD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H7-Coil Deep TMS for CUDDevice
Also called H7-Coil Deep TMS Treatment
The Study group will receive dTMS treatment three times a day for ten days.
| Study group | Role | What they receive |
|---|---|---|
| H7-Coil Deep TMS Treatment | Experimental | H7-Coil Deep TMS Treatment Receives: Device: H7-Coil Deep TMS for CUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility-related endpoints - adherence to dTMS
Number of completer treatment sessions
Measured: after 10 days of treatment sessions
Feasibility-related endpoints - retention rates
Number of patients who did not completed the total (40) sessions
Measured: after 10 days of treatment sessions
Adverse Events reported
Adverse events reported
Measured: up to three months after end of the treatment
Secondary outcomes (5)
Percentage of Positive Urine Drug Screen to Stimulants
Presence of Stimulants in the Drug Screen Panel
Measured: up to three months after end of the treatment
Percentage change on Stimulants Craving Questionnaire
Percentage change on Stimulants Craving Questionnaire
Measured: 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)
Measured: 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)
Measured: 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)
Measured: T0 (week 0), T2 (week 4), T3 (week 6), T4 (week 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start2 Nov 2022
- Primary completion31 Dec 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stimulants Use DisorderStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Miron, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274828
- Sponsor's protocol ID
- 21.358
- Status last verified
- Apr 2024
- First submitted
- 16 Feb 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05274828
- Acronym / sponsor ID
- 21.358
- Conditions
- Stimulants Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| H7-Coil Deep TMS Treatment | Experimental | Device: H7-Coil Deep TMS for CUDH7-Coil Deep TMS Treatment |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H7-Coil Deep TMS for CUDAlso: H7-Coil Deep TMS TreatmentThe Study group will receive dTMS treatment three times a day for ten days. | Device | H7-Coil Deep TMS Treatment |
Primary outcome
Feasibility-related endpoints - adherence to dTMS
Time frame: after 10 days of treatment sessions
Number of completer treatment sessions
Feasibility-related endpoints - retention rates
Time frame: after 10 days of treatment sessions
Number of patients who did not completed the total (40) sessions
Adverse Events reported
Time frame: up to three months after end of the treatment
Adverse events reported
5 secondary outcomes
Percentage of Positive Urine Drug Screen to Stimulants
Time frame: up to three months after end of the treatment
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 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 Patient Health Questionnaire (PHQ-9)
Time frame: T0 (week 0), T2 (week 4), T3 (week 6), T4 (week 14)
Percentage change on General Anxiety Disorder (GAD-7)
Time frame: T0 (week 0), T2 (week 4), T3 (week 6), T4 (week 14)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Philippe Miron, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H7-Coil Deep TMS for CUD in people with Stimulants Use Disorder, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility-related endpoints - adherence to dTMS (time frame: after 10 days of treatment sessions). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.