RECRUITING

tDCS to Decrease Opioid Relapse (UH3)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

tDCS to Decrease Opioid Relapse (UH3)

Quick Facts

Study Start:2024-04-17
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06432465

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. current opioid dependence
  2. 2. between 21-60 years of age
  3. 3. recent initiation of buprenorphine or methadone (≤30days)
  4. 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.
  1. 1. current diagnosis of organic brain disorder (e.g., Parkinson's disease, Huntington's disease, multiple sclerosis, intracranial mass/infection, hydrocephalus)
  2. 2. bipolar, schizophrenia, schizoaffective, or schizophreniform disorder, or current psychosis associated with any disorder
  3. 3. current suicidality
  4. 4. evidence of significant neurocognitive dysfunction
  5. 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. 6. probation/parole requirements or an upcoming move that might interfere with protocol participation
  7. 7. planning to terminate buprenorphine or methadone in less than 3 months
  8. 8. current pregnancy or plan to become pregnant in the next month.

Contacts and Locations

Study Contact

Ana M Abrantes, Ph.D.
CONTACT
4014556440
ana_abrantes@brown.edu
Julie A Desaulniers, M.S.
CONTACT
4014556219
jdesaulniers@butler.org

Principal Investigator

Abrantes Abrantes, Ph.D.
PRINCIPAL_INVESTIGATOR
Butler Hospital
Michael Stein, M.D.
PRINCIPAL_INVESTIGATOR
Boston University

Study Locations (Sites)

Butler Hospital
Providence, Rhode Island, 02906
United States

Collaborators and Investigators

Sponsor: Butler Hospital

  • Abrantes Abrantes, Ph.D., PRINCIPAL_INVESTIGATOR, Butler Hospital
  • Michael Stein, M.D., PRINCIPAL_INVESTIGATOR, Boston University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-17
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-04-17
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • opioid craving
  • buprenorphine
  • methadone
  • EEG
  • transcranial direct current stimulation

Additional Relevant MeSH Terms

  • Opioid Use Disorder