What side effects are associated with this type of intervention?

The most common treatments for Opioid Use Disorder (OUD) include opioid agonist treatments such as methadone and buprenorphine, and neuromodulation therapies like repetitive transcranial magnetic stimulation (rTMS). Opioid agonist treatments can cause side effects such as constipation, sweating, sexual dysfunction, and potential for dependence. rTMS, which is being studied for its potential to improve executive function and reduce emotional arousal, generally has mild side effects including headache, scalp discomfort, and, rarely, seizures. Both treatments aim to reduce opioid cravings and improve treatment retention, but they come with their respective side effect profiles that should be discussed with a healthcare provider.

What prior FDA approvals exist?

FDA-approved treatments for Opioid Use Disorder primarily include opioid agonist therapies such as methadone, buprenorphine, and the opioid antagonist naltrexone. These medications work by reducing cravings and withdrawal symptoms, thereby supporting recovery. Repetitive transcranial magnetic stimulation (rTMS) is being studied as a novel approach to modulate neural activity, potentially improving executive function and reducing emotional arousal, which could enhance treatment outcomes for individuals undergoing methadone treatment.

What other types of research exist?

Promising, novel alternatives to rTMS for Opioid Use Disorder patients include transcutaneous supraorbital nerve stimulation and remote electrical neuromodulation. Both methods have shown efficacy in reducing pain and modulating neural activity, which could potentially improve executive function and reduce emotional arousal.

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Other

rTMS for Opioid Use Disorder (TOTS Trial)

N/A

Waitlist Available

Research Sponsored by Wayne State University

Eligibility Criteria Checklist

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

Must have

Males and non-pregnant/non-lactating females

Age 21-70 years

Must not have

Medical conditions prohibiting use of rTMS

Untreated or uncontrolled past-year diagnosis of major depression, generalized anxiety disorder, obsessive compulsive disorder, or post-traumatic stress disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from sham to active condition (randomized to occur on days 6-12 and 18-24, respectively)

Summary

This trial is testing whether using magnetic fields to stimulate specific brain areas can help adults with opioid addiction. The goal is to improve self-control and reduce stress-related cravings to prevent relapse. Accumulating evidence shows that magnetic fields can affect a variety of opioid-mediated behavioral and physiological functions.

Who is the study for?

This trial is for adults aged 21-70 with opioid use disorder who are currently in methadone or buprenorphine treatment, right-handed, and have an IQ score over 80. They should not be heavy users of alcohol or marijuana. People with certain mental health disorders, recent use of other illicit drugs, or medical conditions that rTMS isn't safe for cannot join.

What is being tested?

The study tests if repetitive transcranial magnetic stimulation (rTMS) can help people with opioid addiction by targeting brain areas linked to substance use and cognitive functions like decision-making and emotional control. Participants will receive rTMS while undergoing standard methadone treatment.

What are the potential side effects?

rTMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in rare cases. It's generally considered safe but might not be suitable for everyone due to these potential side effects.

Eligibility Criteria

Inclusion Criteria

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

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I am a male or a female not currently pregnant or breastfeeding.

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I am between 21 and 70 years old.

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My cognitive abilities are intact.

Exclusion Criteria

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

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I do not have any health issues that prevent me from using rTMS.

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I have not treated or controlled my depression, anxiety, OCD, or PTSD in the past year.

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I am not taking any medications that are not allowed in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from sham to active condition (randomized to occur on days 6-12 and 18-24, respectively)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from sham to active condition (randomized to occur on days 6-12 and 18-24, respectively)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from sham to active condition (randomized to occur on days 6-12 and 18-24, respectively) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Emotional Arousal task rating

Opioid progressive ratio breakpoint

Treatment success

+1 more

Secondary study objectives

Digit Span total score

Monetary delay discounting

Positive and Negative Affect Scale total score

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Active 10 Hz dlPFC rTMSExperimental Treatment1 Intervention

10 Hz dorsolateral prefrontal cortex stimulation for 10 sessions (2 sessions/day X 5 days)

Group II: Active 1 Hz mPFC rTMSExperimental Treatment1 Intervention

1 Hz medial prefrontal cortex stimulation for 10 sessions (2 sessions/day X 5 days)

Group III: Sham dlPFC rTMSPlacebo Group1 Intervention

inactive dorsolateral prefrontal cortex stimulation for 10 sessions (2 sessions/day X 5 days)

Group IV: Sham mPFCPlacebo Group1 Intervention

inactive medial prefrontal cortex stimulation for 10 sessions (2 sessions/day X 5 days)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

rTMS

2016

Completed Phase 3

~840

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Opioid Use Disorder (OUD) include pharmacological approaches like methadone and buprenorphine, which bind to opioid receptors to alleviate cravings and withdrawal symptoms. Non-pharmacological treatments, such as Repetitive Transcranial Magnetic Stimulation (rTMS), modulate neural activity to enhance executive function and reduce emotional arousal. These mechanisms are crucial for OUD patients as they help manage both the physiological and psychological aspects of addiction, thereby improving treatment retention and reducing the likelihood of relapse.

The hypodopaminergic state ten years after: transcranial magnetic stimulation as a tool to test the dopamine hypothesis of drug addiction.