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Neuromodulation

Neuromodulation for Opioid Addiction

N/A

Recruiting

Led By Jazmin Y Camchong, PhD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Must not have

Clinical evidence for Wernicke-Korsakoff syndrome

Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness>30 min, HIV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up between 2 weeks of abstinence and 2 months later

Summary

This trial will test whether tDCS can reduce relapse in people with opioid use disorder.

Who is the study for?

This trial is for individuals aged 18-60 with opioid use disorder (OUD) who have been abstinent for 1-2 weeks and are part of the Lodging Plus Program. They must be able to consent and follow study procedures, with OUD as their primary diagnosis even if they use other drugs. Excluded are those with conditions affecting study participation or tDCS/MRI contraindications like metal implants, seizures, or severe head injuries.

What is being tested?

The trial tests Transcranial Direct Current Stimulation (tDCS), a non-invasive brain stimulation technique that may modulate brain connectivity. It aims to reduce relapse in people with OUD by targeting brain biomarkers associated with vulnerability to relapse.

What are the potential side effects?

Potential side effects of tDCS include mild discomfort at the electrode site, itching, tingling during application, headache, fatigue, nausea or insomnia post-treatment. Serious side effects are rare but can include mania in vulnerable individuals.

Eligibility Criteria

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 Wernicke-Korsakoff syndrome.

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I have a condition or received treatment that affected my nervous system.

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I have had a head injury with a skull fracture or was unconscious for over 30 minutes.

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I am younger than 18 or older than 60.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ between 2 weeks of abstinence and 2 months later

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~between 2 weeks of abstinence and 2 months later

This trial's timeline: 3 weeks for screening, Varies for treatment, and between 2 weeks of abstinence and 2 months later for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in brain functional connectivity as measured by functional magnetic resonance imaging

Secondary study objectives

Correlation between functional connectivity change and clinical outcome

Correlation between functional connectivity change and craving scores

Side effects data

From 2018 Phase 2 trial • 54 Patients • NCT01726673

back pain flair up

Myasthenia Gravis

100%

80%

60%

40%

20%

Study treatment Arm

tDCS + Robotic Arm Therapy

tDCS Sham + Robotic Arm Therapy

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental: active tDCSExperimental Treatment1 Intervention

Subjects that are randomly assigned to this arm will undergo 5 sessions of tDCS.

Group II: Sham Comparator: sham tDCSPlacebo Group1 Intervention

Subjects randomly assigned to sham-tDCS will receive very low current stimulation at the beginning and end of the session, mimicking the feeling of current stimulation in the scalp, but not reaching levels that will stimulate brain function. There will be a total of 5 sham tDCS sessions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Direct Current Stimulation (tDCS)

2016

Completed Phase 2

~2150

0 / 4Eligibility criteria met