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Non-invasive Brain Stimulation

tDCS + TUS for Opioid Use Disorder

N/A

Recruiting

Led By Ciro R Estebanez, MD PhD

Research Sponsored by Case Western Reserve University

Eligibility Criteria Checklist

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

Must have

18 to 85 years old.

Suffering from severe depression (with a score of >30 in the Beck Depression Inventory (BDI), PHQ-9≥10).

Must not have

History of unexplained fainting spells as self-reported.

History of brain surgery as self-reported.

Timeline

Screening 1 day

Treatment Varies

Follow Up 24 weeks

Summary

This trial will study whether transcranial Direct Current Stimulation (tDCS) + Transcranial Ultrasound (TUS) can help treat addiction in people with chronic pain who use opiates. The investigators think active stimulation will be better than fake stimulation.

Who is the study for?

This trial is for adults aged 18-85 with opioid use disorder (OUD) and chronic pain, who have been diagnosed according to DSM-5 criteria. Participants must consent to the study, live locally without relocation plans, and can't be on high doses of methadone. Excluded are pregnant individuals, those with a history of illegal stimulant use or certain neurological disorders, recent brain surgery patients, or those on new antiepileptic drugs.

What is being tested?

The study tests if transcranial Direct Current Stimulation (tDCS) combined with Transcranial Ultrasound (TUS) helps treat addiction in people with OUD and chronic pain. It compares active stimulation's effects on drug use reduction and psychosocial improvement against sham (fake) treatments.

What are the potential side effects?

While not explicitly listed in the provided information, tDCS and TUS may cause mild side effects such as headache, scalp discomfort at the site of electrode application for tDCS; TUS might include local discomfort or skin irritation.

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 85 years old.

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I have severe depression based on standard tests.

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I currently have cancer.

Exclusion Criteria

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

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I have had fainting spells that doctors couldn't explain.

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I have had brain surgery.

Timeline

Screening ~ 1 day1 visit

Treatment ~ Varies

Follow Up ~ 24 weeks9 visits

Screening ~ 1 day

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 1 day for screening, Varies for treatment, and 24 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

Change in drug use from baseline.

Secondary study objectives

15-item Barrett Impulsivity scale

Changes in pain as measured by the Visual Analog Scale (VAS)

Changes in the Verbal Rating Scale (VRS) for Pain

+13 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active (tDCS) + Active TUSActive Control1 Intervention

Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS)

Group II: Sham (tDCS) + Sham TUSPlacebo Group1 Intervention

Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).

0 / 5Eligibility criteria met