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Device

rTMS for Opioid Use Disorder

N/A
Recruiting
Research Sponsored by West Virginia University
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1, week 3, and week 7
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
I haven't used opioids or illegal drugs, except for prescribed buprenorphine/naloxone and marijuana, confirmed by a urine test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1, week 3, and week 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1, week 3, and week 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
rTMS reduces substance use
Secondary outcome measures
rTMS applied to the DLPFC provides neuromodulatory effects
Other outcome measures
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
176 Previous Clinical Trials
60,194 Total Patients Enrolled

Media Library

Repetitive Transcranial Magnetic Stimulation (rTMS) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04157062 — N/A
Opioid Use Disorder Research Study Groups: Study Group
Opioid Use Disorder Clinical Trial 2023: Repetitive Transcranial Magnetic Stimulation (rTMS) Highlights & Side Effects. Trial Name: NCT04157062 — N/A
Repetitive Transcranial Magnetic Stimulation (rTMS) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04157062 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications must potential participants meet in order to be included in this research?

"This clinical trial is seeking 20 participants aged 18 to 60 who have a history of substance abuse. In order to be eligible, they must satisfy the following criteria: currently participating in the COAT Program, present with a Columbia-Suicide Severity Rating Scale score lower than 4, meet DSM-V standards for primary opioid use disorder confirmed through structured interview process and demonstrate abstinence from opioids (except buprenorphine/naloxone as prescribed) and other illicit drugs apart from marijuana which can be verified via urine drug screen."

Answered by AI

Is this experiment open to the geriatric population?

"To be included in this medical experiment, participants must fall between 18 and 60 years old. For those who are younger or older than the specified age range, there are 405 trials for minors and 1085 studies tailored to seniors."

Answered by AI

What is the enrollment size for this experimental trial?

"Yes, there is authenticated information on clinicaltrials.gov that verifies this study's active search for participants. Originally posted in September 2021, it was last updated on July 13th 2022 and plans to enrol 20 individuals at a single site."

Answered by AI

Is there still an opportunity to participate in this experiment?

"Affirmative. According to clinicaltrials.gov's records, this trial is still open for recruitment and has been since September 30th 2021. The most recent update was made on July 13 2022; the trial requires 20 individuals from one medical centre."

Answered by AI

Who else is applying?

What state do they live in?
West Virginia
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder
James Mahoney 2021. "An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04157062.
All > Substance Abuse > Transcranial Magnetic Stimulation
~2 spots leftby Sep 2024
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