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Behavioural Intervention
TMS for Methamphetamine Abuse
N/A
Recruiting
Led By Sooraj John, M.D.
Research Sponsored by Carilion Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline/visit 2, day 5 of itbs/sham tms, 3 days after-, 1 week after-, 2 weeks-after, and one month after completion of itbs/sham tms
Summary
This trial is using a treatment called Transcranial Magnetic Stimulation (TMS) to see if it can help with treating Methamphetamine Use Disorder. People with this disorder will receive 5 TMS
Who is the study for?
This trial is for individuals struggling with Methamphetamine Use Disorder. Participants will be randomly assigned to receive either real TMS treatment or a sham (placebo) version over five consecutive sessions.
What is being tested?
The study is testing the effectiveness of Transcranial Magnetic Stimulation (TMS), a non-invasive brain stimulation technique, in treating Methamphetamine Use Disorder compared to a sham procedure that mimics TMS without active treatment.
What are the potential side effects?
TMS may cause discomfort at the site of application, headache, lightheadedness, or seizures in rare cases. The sham procedure should have fewer effects since it's designed to mimic TMS without delivering actual stimulation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline/visit 2, daily during itbs/sham-tms, 3 days after-, 1 week after-, 2 weeks-after, and one month after completion of itbs/sham tms
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline/visit 2, daily during itbs/sham-tms, 3 days after-, 1 week after-, 2 weeks-after, and one month after completion of itbs/sham tms
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Stimulant Craving Questionnaire (STCQ)
Urine Drug Screen (UDS)
Secondary study objectives
Clinical Global Impression - Improvement (CGI-I)
Clinical Global Impression - Severity (CGI-S)
Generalized Anxiety Disorder-7 (GAD-7)
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Transcranial Magnetic Stimulation (TMS)Experimental Treatment1 Intervention
This arm receives the TMS treatments.
Group II: Sham-TMSPlacebo Group1 Intervention
This arm receives sham TMS treatments.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Magnetic Stimulation
2017
Completed Phase 4
~730
Find a Location
Who is running the clinical trial?
Carilion ClinicLead Sponsor
78 Previous Clinical Trials
14,840 Total Patients Enrolled
Virginia Polytechnic Institute and State UniversityOTHER
152 Previous Clinical Trials
24,953 Total Patients Enrolled
Sooraj John, M.D.Principal InvestigatorCarilion Clinic
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