ClinConnect ClinConnect Logo
Search / Trial NCT06432465

tDCS to Decrease Opioid Relapse (UH3)

Launched by BUTLER HOSPITAL · May 23, 2024

Trial Information

Current as of May 24, 2025

Recruiting

Keywords

Opioid Craving Buprenorphine Methadone Eeg Transcranial Direct Current Stimulation

ClinConnect Summary

This clinical trial is studying a treatment called transcranial direct current stimulation (tDCS) to see if it can help people with opioid use disorder reduce their chances of relapse. The researchers will focus on how this treatment affects the brain and behavior, particularly looking at cravings and the long-term effects on brain activity. They are currently recruiting participants who are between 21 and 60 years old, have recently started treatment with buprenorphine or methadone, and are receiving care at Butler Hospital or in the community.

If you join the trial, you will be randomly assigned to receive either the active tDCS treatment or a placebo (sham control), which means you might not know if you are getting the actual treatment. The goal is to understand how effective tDCS is in helping people maintain their recovery from opioid use. It’s important to note that there are some exclusions, such as having certain brain disorders or significant mental health issues, so not everyone will be eligible to participate. If you have questions about your eligibility or the study itself, the research team can provide more information.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. current opioid dependence
  • 2. between 21-60 years of age
  • 3. recent initiation of buprenorphine or methadone (≤30days)
  • 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.

About Butler Hospital

Butler Hospital is a leading psychiatric and behavioral health facility dedicated to advancing mental health care through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital focuses on developing and evaluating new therapeutic interventions, aiming to improve treatment outcomes for patients with various mental health conditions. With a commitment to evidence-based practice, Butler Hospital collaborates with a multidisciplinary team of experts to ensure rigorous methodology and ethical standards in all research endeavors, ultimately enhancing the quality of care for individuals in need.

Locations

Providence, Rhode Island, United States

Patients applied

0 patients applied

Trial Officials

Abrantes Abrantes, Ph.D.

Principal Investigator

Butler Hospital

Michael Stein, M.D.

Principal Investigator

Boston University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported