| NCT ID | NCT06432465 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Butler Hospital |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-04-17 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-04-17 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Abrantes Abrantes, Ph.D.
PRINCIPAL INVESTIGATOR
Butler Hospital
Frequently Asked Questions
Who can join the NCT06432465 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 60 Years, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06432465 currently recruiting?
Yes, NCT06432465 is actively recruiting participants. Contact the research team at ana_abrantes@brown.edu for enrollment information.
Where is the NCT06432465 trial being conducted?
This trial is being conducted at Providence, United States.
Who is sponsoring the NCT06432465 clinical trial?
NCT06432465 is sponsored by Butler Hospital. The principal investigator is Abrantes Abrantes, Ph.D. at Butler Hospital. The trial plans to enroll 100 participants.