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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

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

No Placebo-Only Group

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 below

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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:

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I do not have conditions like severe heart issues, glaucoma, brain lesions, seizures, or any implanted medical devices.

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I have difficulty moving around.

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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

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 5Eligibility criteria met