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Behavioural Intervention
rTMS for Stimulant Use Disorder (CTN-0108 Trial)
N/A
Waitlist Available
Led By Madhukar Trivedi, MD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-65
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first treatment week (week 1) to end of treatment at 8 weeks
Awards & highlights
CTN-0108 Trial Summary
This trial is testing if a non-invasive brain stimulation technique could help people with cocaine or methamphetamine addiction to cut down or stop use.
Who is the study for?
Adults aged 18-65 with moderate to severe cocaine or methamphetamine use disorder, who have used these substances frequently in the last month and are interested in reducing their usage. Women must agree to use birth control during the study. Participants should not be currently receiving substance use disorder treatment and must be on a stable dose of certain medications if prescribed.Check my eligibility
What is being tested?
The trial is testing repetitive transcranial magnetic stimulation (rTMS) as a potential treatment for cocaine or methamphetamine addiction. Over eight weeks, participants will receive either real rTMS or sham (placebo) rTMS, with follow-ups at the end of treatment and up to 16 weeks after starting.See study design
What are the potential side effects?
While specific side effects are not listed here, rTMS can sometimes cause discomfort at the stimulation site, headache, lightheadedness, or seizures in very rare cases. The placebo group may experience no actual side effects from the sham procedure.
CTN-0108 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
CTN-0108 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first treatment session (week 1, first study visit) to end of treatment at 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first treatment session (week 1, first study visit) to end of treatment at 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants who receive at least 20 sessions of rTMS/sham over the treatment period.
Secondary outcome measures
Percent of negative UDS from weekly UDS
CTN-0108 Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: rTMSActive Control1 Intervention
Participants will receive up to 30 rTMS sessions within the 8-week treatment period.
Group II: Sham (Placebo)Placebo Group1 Intervention
Participants will receive up to 30 sham rTMS sessions within the 8-week treatment period.
Find a Location
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,488 Previous Clinical Trials
2,622,522 Total Patients Enrolled
31 Trials studying Cocaine Abuse
9,808 Patients Enrolled for Cocaine Abuse
Medical University of South CarolinaLead Sponsor
940 Previous Clinical Trials
7,396,835 Total Patients Enrolled
Madhukar Trivedi, MDPrincipal InvestigatorUniversity of Texas South Western
14 Previous Clinical Trials
10,947 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The person has used cocaine or methamphetamine 10 times in the past 30 days.I am willing to use birth control during the study.You want to reduce the amount of cocaine or methamphetamine you use.I am between 18 and 65 years old.The study participants must be able to understand the study procedures and provide written informed consent to participate in the study.I have been diagnosed with bipolar disorder.I have been on the same dose of my anxiety or seizure medication for at least 4 weeks.I have previously undergone TMS therapy.I have had a seizure without a known cause in my lifetime or any seizure in the last 6 months.I have a documented history of brain tumors or lesions.I am between 18 and 65 years old.I am willing to use birth control during the study.I have been on a stable dose of benzodiazepines or anticonvulsants for at least 4 weeks.Use Cocaine or Methamphetamine (C/M) at least once a week for the past 12 weeks
Research Study Groups:
This trial has the following groups:- Group 1: rTMS
- Group 2: Sham (Placebo)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Cocaine Abuse Patient Testimony for trial: Trial Name: NCT04907357 — N/A
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