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Behavioural Intervention
Deep TMS for Methamphetamine Addiction
N/A
Waitlist Available
Led By Claudia B Padula, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be within the age range of 25-75
Participants must be able to read, verbalize, understand, and voluntarily sign the Informed Consent Form prior to participation in study procedures in English
Must not have
Recent suicide attempt within the last 30 days or presence of current suicidal plan or intent. Patients at risk for suicide will be required to establish a written safety plan involving their primary therapist before entering the study
Acute or unstable chronic illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post-treatment
Summary
This trial will test if deep transcranial magnetic stimulation (dTMS) can help Veterans with a methamphetamine addiction.
Who is the study for?
This trial is for veterans struggling with methamphetamine addiction. Participants should be seeking treatment and have no other major health issues that could interfere with the study.
What is being tested?
The study tests deep transcranial magnetic stimulation (dTMS) using an H4 coil. Some participants will receive real dTMS, while others get a sham (fake) treatment to compare outcomes.
What are the potential side effects?
dTMS may cause discomfort at the site of stimulation, headache, lightheadedness, or seizures in very rare cases. Most side effects are mild and temporary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 25 and 75 years old.
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I can read, understand, and sign the consent form in English.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not attempted suicide nor planned it in the last 30 days.
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I do not have any sudden or severe ongoing illnesses.
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I am taking medication that affects seizure risk.
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I cannot stop taking my seizure-risk medication safely before treatment.
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I have a history of bipolar disorder or psychosis.
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I have a brain tumor, stroke, or another active brain condition.
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I have had a brain injury with unconsciousness for more than 10 minutes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post-treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Insula Function
Percentage of Days Abstinent
Secondary study objectives
Binary Relapse
Other Salience Network Function
Resting-State Salience Network
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active dTMSExperimental Treatment1 Intervention
Participants will receive 30 active dTMS treatments, administered 3 times per day over 10 consecutive business days. Each treatment visit will last approximately 30 minutes in total.
Group II: Sham dTMSPlacebo Group1 Intervention
Participants will receive 30 sham dTMS sessions, administered 3 times per day over 10 consecutive business days. Each treatment visit will last approximately 30 minutes in total.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,467 Previous Clinical Trials
17,496,072 Total Patients Enrolled
VA Palo Alto Health Care SystemFED
93 Previous Clinical Trials
58,154 Total Patients Enrolled
Claudia B Padula, PhDPrincipal InvestigatorStanford University
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