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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be abstinent from opioids (other than prescribed buprenorphine/naloxone) and illicit substances other than marijuana at the time of the enrollment, confirmed via urine drug screen
Be between 18 and 65 years old
Must not have
Medical conditions that preclude rTMS: including vasodepressor syncope, glaucoma, increased intracranial pressure, cardiac disease, migraine disorder, cerebral vascular events (cerebral vascular accident, transient ischemic attack), any brain lesions (such multiple sclerosis), brain injury, seizure disorder (or family history) of any type, and have cardiac pacemakers or implanted medication pumps
Mobility limitations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1, week 3, and week 7
Awards & highlights
Summary
This trial will study whether rTMS can help people with opioid use disorders by reducing cravings and improving thinking skills.
Who is the study for?
This trial is for individuals enrolled in the COAT Program, who are abstinent from opioids and illicit substances (except marijuana), confirmed by a drug screen. They must meet criteria for Opioid Use Disorder, have stable mental health (with specific criteria on suicide risk assessment), and agree to use contraception. Exclusions include major cognitive disorders, pregnancy, certain medical conditions that make rTMS unsafe, prior rTMS treatment, and severe psychiatric illnesses other than depression.
What is being tested?
The study investigates how repetitive Transcranial Magnetic Stimulation (rTMS) might help reduce opioid use and cravings while improving cognitive functions in people with Opioid Use Disorder. It's an open-label trial where all participants receive the intervention without any placebo or control group.
What are the potential side effects?
While not explicitly listed here, common side effects of rTMS may include headaches or scalp discomfort at the stimulation site during treatment sessions. There could also be a risk of seizure although it's rare.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't used opioids or illegal drugs, except for prescribed buprenorphine/naloxone and marijuana, confirmed by a urine test.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have conditions like severe heart issues, glaucoma, brain lesions, seizures, or any implanted medical devices.
Select...
I have difficulty moving around.
Select...
I am not willing to stop taking my current medications.
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I have previously undergone rTMS treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1, week 3, and week 7
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1, week 3, and week 7
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
rTMS reduces substance use
Secondary study objectives
rTMS applied to the DLPFC provides neuromodulatory effects
Other study objectives
Functional connectivity changes
Trial Design
1Treatment groups
Experimental Treatment
Group I: Study GroupExperimental Treatment1 Intervention
Participants will receive a type of TMS called repetitive TMS (rTMS) wherein the magnetic pulses delivered will be close together in a rapid sequence. They will receive excitatory rTMS with a stimulation frequency of 10 Hz or higher.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Repetitive Transcranial Magnetic Stimulation (rTMS)
2019
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
West Virginia UniversityLead Sponsor
181 Previous Clinical Trials
63,691 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't used opioids or illegal drugs, except for prescribed buprenorphine/naloxone and marijuana, confirmed by a urine test.I do not have conditions like severe heart issues, glaucoma, brain lesions, seizures, or any implanted medical devices.You have been diagnosed with a severe opioid addiction by a specialized doctor using a specific set of questions.You have a significant mental health condition, other than depression, as defined by the DSM-V guidelines.I have difficulty moving around.You have metal objects inside your head (excluding dental fillings).You have uncorrected vision problems that are not fixed with glasses or contacts.I am not willing to stop taking my current medications.I have previously undergone rTMS treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Study Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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