Actively Recruiting

Phase Not Applicable
Age: 21Years - 60Years
All Genders
NCT06432465

tDCS to Decrease Opioid Relapse (UH3)

Led by Butler Hospital · Updated on 2024-12-04

100

Participants Needed

1

Research Sites

141 weeks

Total Duration

On this page

Sponsors

B

Butler Hospital

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

tDCS to Decrease Opioid Relapse (UH3)

Who Can Participate

Age: 21Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Current opioid dependence
  • Age between 21 and 60 years
  • Recently started buprenorphine or methadone treatment (within 30 days)
  • Enrolled in Butler Hospital treatment programs or receiving opioid treatment services in the community
Not Eligible

You will not qualify if you...

  • Diagnosis of organic brain disorders such as Parkinson's, Huntington's, multiple sclerosis, intracranial mass or infection, or hydrocephalus
  • Bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, or current psychosis
  • Current suicidality
  • Significant neurocognitive dysfunction
  • Medical conditions increasing tDCS risks, including seizure disorder, nonremovable intracranial metal objects (except dental fillings/implants), scalp skin disease or active lesions, active migraine or headache disorder, recent traumatic brain injury or skull fracture (within 1 year), or implanted medical devices interacting with electromagnetic fields
  • Current probation or parole requirements or planned moves interfering with study participation
  • Planning to stop buprenorphine or methadone treatment within less than 3 months
  • Current pregnancy or plans to become pregnant within the next month

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Butler Hospital

Providence, Rhode Island, United States, 02906

Actively Recruiting

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Research Team

A

Ana M Abrantes, Ph.D.

CONTACT

J

Julie A Desaulniers, M.S.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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