What side effects are associated with this type of intervention?

Theta Burst Stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), is generally well-tolerated but can cause side effects such as headaches, scalp discomfort, and, in rare cases, seizures. N-acetylcysteine (NAC), which modulates glutamate levels, is also generally well-tolerated but can lead to gastrointestinal issues like nausea, vomiting, and diarrhea, as well as potential allergic reactions. Other common treatments for Cocaine Use Disorder may include medications like topiramate and varenicline, which can cause side effects such as dizziness, anxiety, and impaired concentration.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of Cocaine Use Disorder. Research is ongoing to find effective treatments, including the combination of Theta Burst Stimulation (TBS), which modulates brain activity, and N-acetylcysteine (NAC), which modulates glutamate levels. These approaches are being studied for their potential to reduce cocaine craving and improve treatment outcomes.

What other types of research exist?

Promising novel alternatives for treating Cocaine Use Disorder in 2024 include repetitive transcranial magnetic stimulation (rTMS) and pharmacological agents such as topiramate, which may modulate compulsive behaviors, and quetiapine, which has shown behavioral improvement in related disorders.

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Other

N-acetylcysteine + TBS for Cocaine Use Disorder (COCA Trial)

Phase 2

Waitlist Available

Led By Hesheng Liu, PhD

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

Does not have a history of claustrophobia leading to significant clinical anxiety symptoms

Is not at elevated risk of seizure (i.e., does not have a history of seizures, is not currently prescribed medications known to lower seizure threshold)

Must not have

Past head injury or primary neurological disorder associated with MRI abnormalities, including dementia, MCI, brain tumors, epilepsy, Parkinson's disease, or demyelinating diseases

Individuals with unstable medical illness (e.g., hypertension, diabetes, myocardial infarction)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 weeks

Summary

This trial tests a combination of brain stimulation and a supplement to reduce cocaine cravings and improve brain response. It targets people addicted to cocaine who struggle with cravings and brain reactions to drug-related cues. The treatment works by using magnetic pulses to reset brain activity and a supplement to balance brain chemicals.

Who is the study for?

This trial is for adults aged 18-65 with cocaine use disorder who are fluent in English and currently receiving outpatient treatment for substance issues. Participants must live within 50 miles of the study site, have no history of seizures or metal implants in the head/neck, and not be at risk for MRI-related complications like claustrophobia or certain brain injuries.

What is being tested?

The trial tests whether combining theta burst stimulation (TBS) with N-acetylcysteine (NAC) can reduce cravings and alter brain responses to cocaine cues in individuals with cocaine use disorder. It aims to understand if this combination therapy is more effective than current treatments.

What are the potential side effects?

Potential side effects may include discomfort at the TBS application site, headache, dizziness, nausea from NAC, and possible allergic reactions. The risks associated with MRI scans include discomfort due to loud noises or confined spaces.

Eligibility Criteria

Inclusion Criteria

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

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I do not have a history of claustrophobia causing severe anxiety.

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I don't have a history of seizures and am not on medication that increases seizure risk.

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I am between 18 and 65 years old.

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I have never had a severe head injury or been told I have brain bleeding.

Exclusion Criteria

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

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I have had a head injury or a brain condition that shows up on MRI scans.

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My medical conditions like high blood pressure or diabetes are under control.

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I am taking medication for mental health, seizures, or ADHD.

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I do not have any disabilities that would prevent me from completing study tasks.

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I suffer from chronic migraines.

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I have not had electroconvulsive therapy in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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

Magnitude of change in brain functional connectivity

Magnitude of change in fMRI brain response to images from NAC

Magnitude of change in fMRI brain response to images from TBS

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Placebo + Theta Burst StimulationExperimental Treatment1 Intervention

Group II: N-acetylcysteine + Theta Burst StimulationExperimental Treatment2 Interventions

Group III: Placebo + Sham Theta Burst StimulationActive Control1 Intervention

Group IV: N-acetylcysteine + Sham Theta Burst StimulationPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

N-acetylcysteine

2008

Completed Phase 4

~1290

Theta-burst stimulation (TBS)

2021

N/A

~160

0 / 10Eligibility 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

Theta Burst Stimulation (TBS) modulates brain activity by delivering rapid bursts of magnetic pulses to specific brain regions, potentially reducing cocaine cravings and altering brain responses to drug-related cues. N-acetylcysteine (NAC) modulates glutamate levels by stimulating the cystine/glutamate exchange, helping to restore extracellular glutamate levels and reduce the risk of relapse. These treatments are important for Cocaine Use Disorder patients as they target the neurobiological underpinnings of addiction, offering potential pathways to reduce cravings and prevent relapse.

Sequential cocaine-alcohol self-administration produces adaptations in rat nucleus accumbens core glutamate homeostasis that are distinct from those produced by cocaine self-administration alone.Neuroadaptations in cystine-glutamate exchange underlie cocaine relapse.