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Behavioural Intervention

Brain Stimulation for Opioid Use Disorder

N/A

Recruiting

Led By Abrantes Abrantes, Ph.D.

Research Sponsored by Butler Hospital

Eligibility Criteria Checklist

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

Must have

Between 21-60 years of age

Be between 18 and 65 years old

Must not have

Current diagnosis of organic brain disorder (e.g., Parkinson's disease, Huntington's disease, multiple sclerosis, intracranial mass/infection, hydrocephalus)

Bipolar, schizophrenia, schizoaffective, or schizophreniform disorder, or current psychosis associated with any disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Summary

"This trial will study the effects of brain stimulation on cognitive function and behavior. Phase I showed changes in brain networks after stimulation. Phase II will involve a larger study to look at long-term effects, such

Who is the study for?

This trial is for individuals with Opioid Use Disorder. Participants should have a history of opioid dependency but are currently seeking treatment. The study excludes those who might have other medical conditions that could interfere with the trial or pose risks.

What is being tested?

The study tests if tDCS, a non-invasive brain stimulation technique, can reduce opioid relapse by targeting the brain's cognitive control network. It compares active tDCS to sham (placebo) treatment in a randomized setup to see long-term effects on cravings and relapse.

What are the potential side effects?

tDCs is generally considered safe but may cause mild side effects such as tingling, itching, or discomfort at the electrode sites on the scalp; headache; fatigue; and nausea.

Eligibility Criteria

Inclusion Criteria

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

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I am between 21 and 60 years old.

Exclusion Criteria

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

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I do not have a brain disorder like Parkinson's, Huntington's, MS, or brain infection.

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I have been diagnosed with a serious mental health condition like bipolar or schizophrenia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks 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

Opioid Craving

Secondary study objectives

EEG theta activity

opioid relapse

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: active tDCSActive Control1 Intervention

Each participant will undergo 5 consecutive (i.e., business days) sessions of active tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.

Group II: sham tDCSPlacebo Group1 Intervention

Each participant will undergo 5 consecutive (i.e., business days) sessions of sham tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.

0 / 3Eligibility criteria met