← Back to all trials
Recruiting
NCT06432465
tDCS to Decrease Opioid Relapse (UH3)
Conditions: Opioid Use Disorder
Sex: All
Ages: 21 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Butler Hospital
Location: Butler Hospital Providence Rhode Island
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. current opioid dependence
2. between 21-60 years of age
3. recent initiation of buprenorphine or methadone (≤90 days)
4. 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.
Exclusion Criteria:
1. current diagnosis of organic brain disorder (e.g., Parkinson's disease, Huntington's disease, multiple sclerosis, intracranial mass/infection, hydrocephalus)
2. bipolar, schizophrenia, schizoaffective, or schizophreniform disorder, or current psychosis associated with any disorder
3. current suicidality
4. evidence of significant neurocognitive dysfunction
5. 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
6. probation/parole requirements or an upcoming move that might interfere with protocol participation
7. planning to terminate buprenorphine or methadone in less than 3 months
8. current pregnancy or plan to become pregnant in the next month.
Source: ClinicalTrials.gov (NCT06432465). StuddyBuddy aggregates publicly available trial information.