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Behavioural Intervention

Brain Stimulation for Opioid Use Disorder

N/A
Recruiting
Led By Michael Stein, M.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
Awards & highlights

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in opioid craving
change in EEG oscillatory targets
lower rates of opioid relapse

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: 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.

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,503 Previous Clinical Trials
2,625,483 Total Patients Enrolled
Butler HospitalLead Sponsor
130 Previous Clinical Trials
16,393 Total Patients Enrolled
Michael Stein, M.D.Principal InvestigatorBoston University
4 Previous Clinical Trials
1,010 Total Patients Enrolled
~67 spots leftby Dec 2026