What side effects are associated with this type of intervention?

Repetitive transcranial magnetic stimulation (rTMS) is generally well-tolerated, but some patients may experience mild side effects such as headaches, scalp discomfort at the stimulation site, tingling, spasms, or twitching of facial muscles. Rarely, rTMS can cause more serious side effects like seizures, particularly in individuals with a history of epilepsy. Other common treatments for cocaine abuse, such as behavioral therapies and medications, may have their own side effects, but these are not directly related to rTMS.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of cocaine abuse. However, repetitive transcranial magnetic stimulation (rTMS) is being studied as a potential treatment. rTMS uses magnetic fields to stimulate nerve cells in the brain, which may help reduce cravings and improve self-control in individuals with cocaine use disorder. This noninvasive neuromodulation technique is still under investigation, and its efficacy and safety are being evaluated in clinical trials.

What other types of research exist?

Promising novel alternatives to rTMS for treating cocaine abuse include noninvasive vagus nerve stimulation (nVNS) and remote electrical neuromodulation (REN). Both have shown potential in clinical trials for other conditions and may offer new avenues for treating substance use disorders.

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Behavioural Intervention

rTMS for Stimulant Use Disorder (CTN-0108 Trial)

N/A

Waitlist Available

Led By Madhukar Trivedi, MD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

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

Must have

Age 18-65

Be older than 18 years old

Must not have

Current or lifetime bipolar disorder

Lifetime history of prior clinical treatment with TMS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first treatment week (week 1) to end of treatment at 8 weeks

Summary

This trial is testing whether using magnetic pulses on the brain can help people who are struggling with cocaine or methamphetamine addiction. The treatment aims to change brain activity to make it easier for them to reduce or stop their drug use. Magnetic pulses have been studied to reduce drug craving in addiction treatment.

Who is the study for?

Adults aged 18-65 with moderate to severe cocaine or methamphetamine use disorder, who have used these substances frequently in the last month and are interested in reducing their usage. Women must agree to use birth control during the study. Participants should not be currently receiving substance use disorder treatment and must be on a stable dose of certain medications if prescribed.

What is being tested?

The trial is testing repetitive transcranial magnetic stimulation (rTMS) as a potential treatment for cocaine or methamphetamine addiction. Over eight weeks, participants will receive either real rTMS or sham (placebo) rTMS, with follow-ups at the end of treatment and up to 16 weeks after starting.

What are the potential side effects?

While specific side effects are not listed here, rTMS can sometimes cause discomfort at the stimulation site, headache, lightheadedness, or seizures in very rare cases. The placebo group may experience no actual side effects from the sham procedure.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

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 have previously undergone TMS therapy.

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I have had a seizure without a known cause in my lifetime or any seizure in the last 6 months.

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I have a documented history of brain tumors or lesions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first treatment session (week 1, first study visit) to end of treatment at 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first treatment session (week 1, first study visit) to end of treatment at 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first treatment session (week 1, first study visit) to end of treatment at 8 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

Percentage of participants who receive at least 20 sessions of rTMS/sham over the treatment period.

Secondary study objectives

Percent of negative UDS from weekly UDS

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: rTMSActive Control1 Intervention

Participants will receive up to 30 rTMS sessions within the 8-week treatment period.

Group II: Sham (Placebo)Placebo Group1 Intervention

Participants will receive up to 30 sham rTMS sessions within the 8-week treatment period.

0 / 5Eligibility 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

Repetitive transcranial magnetic stimulation (rTMS) uses magnetic fields to stimulate nerve cells in the brain, particularly targeting areas involved in addiction and self-control. This stimulation can help reduce cravings and improve self-control by modulating neural circuits that are dysregulated in cocaine addiction. Understanding this mechanism is crucial for patients because it highlights how rTMS can directly influence brain function to alleviate symptoms of addiction, offering a non-invasive treatment option that may be effective when traditional therapies are insufficient.