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rTMS for Opioid Use Disorder

N/A

Waitlist Available

Led By Gregory Sahlem

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Starting buprenorphine and planning on opioid abstinence

Be older than 18 years old

Must not have

Current or lifetime bipolar disorder

Unstable Axis-I condition requiring starting a new medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks

Summary

This trial will involve 80 participants with opioid use disorder who are starting treatment with buprenorphine to quit using opioids. The researchers want to see if an MRI brain marker can predict who will

Who is the study for?

This trial is for individuals with Opioid Use Disorder who are starting buprenorphine treatment to quit opioids. Participants will undergo MRI scans and receive either real or placebo rTMS sessions, while their opioid abstinence is monitored over a 12-week period.

What is being tested?

The study aims to determine if an MRI brain marker can predict successful quitting with buprenorphine and whether adding repetitive Transcranial Magnetic Stimulation (rTMS) improves the chances of quitting opioids compared to a sham version of rTMS.

What are the potential side effects?

While not specified here, common side effects of rTMS may include headache, scalp discomfort at the site of stimulation, tingling or spasms in facial muscles, lightheadedness, and rare risk of seizure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am starting buprenorphine and plan to stop using opioids.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with bipolar disorder.

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I need to start a new medication for an unstable mental health condition.

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I have not had thoughts of or attempted suicide in the last 90 days.

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My health conditions are stable.

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I have a history of dementia or cognitive issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with Relapse Free survival

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active rTMSExperimental Treatment1 Intervention

A total of 50-sessions of standard iTBS (1800 pulses) will be delivered. rTMS-sessions will be ideally administered over 1-week (10-sessions-per-day, 50-minutes inter-session-interval, 5-days), but there will be flexibility in the delivery paradigm so long as participants complete all sessions of rTMS within 6 weeks and come in at least twice per week.

Group II: Sham rTMSPlacebo Group1 Intervention

Double-blind sham-rTMS in an identical fashion to the active-rTMS condition will be delivered.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Active repetitive Transcranial Magnetic Stimulation (rTMS)

2015

N/A

~30

0 / 6Eligibility criteria met