tDCS to Decrease Opioid Relapse (UH3)

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Opioid Use Disorder

In brief

Investigators will measure behavioral and brain responses following transcranial direct current stimulation (tDCS) to the dorsolateral prefrontal cortex (DLPFC) (anode on right DLPFC, cathode on the left DLPFC) delivered during cognitive control network (CCN) priming. In Phase I, the EEG provided validation of expected changes in these networks following tDCS stimulation of the DLPFC. In this current phase (II), the investigators will perform a larger randomized clinical trial (RCT) (active vs. sham control) to address long-term neurobehavioral outcomes, including opioid relapse, craving, and sustained EEG changes.

Key facts

Study ID

NCT06432465

Run by

Butler Hospital

People needed

100

Starts

2024-04-17

Expected to finish

2026-12-31

Last updated by the study team

2026-06-29

Who can join

Age: 21 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• current opioid dependence
• between 21-60 years of age
• recent initiation of buprenorphine or methadone (≤90 days)
• enrolled in Butler Hospital's Alcohol and Drug Inpatient Unit, Alcohol and Drug Partial Hospital Treatment Program, Intensive Outpatient Services, or Outpatient Services at Butler Hospital OR receive opioid-treatment services in the community.

You may not qualify if…

• 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
• current suicidality
• evidence of significant neurocognitive dysfunction
• conditions associated with heightened tDCS risks, e.g., seizure disorder, nonremovable intracranial metal objects (other than dental fillings and dental implants), skin disease or active lesions on the scalp, migraine/other headache disorder with significant active symptoms, traumatic brain injury or skull fracture within the past year, any implanted medical devices or device components that can interact with electromagnetic fields or are controlled by physiological signals
• probation/parole requirements or an upcoming move that might interfere with protocol participation
• planning to terminate buprenorphine or methadone in less than 3 months
• current pregnancy or plan to become pregnant in the next month.

Where it is running

• Butler Hospital — Providence, Rhode Island, United States (enrolling)

Full record on ClinicalTrials.gov

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