tDCS to Decrease Opioid Relapse (UH3)

NCT06432465 | Recruiting DMC FDA Device

• 2 other identifiers: 13173334UH3DA047793
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Opioid Craving

  Modified Penn Alcohol Craving (0 = no craving to 30 = extreme craving)

  2 weeks

Secondary Outcomes (2)

• EEG theta activity

  2 weeks

• opioid relapse

  24 weeks

Study Arms (2)

active tDCS

ACTIVE COMPARATOR

Each participant will undergo 5 consecutive (i.e., business days) sessions of active tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.

Device: active tDCS

sham tDCS

SHAM COMPARATOR

Each participant will undergo 5 consecutive (i.e., business days) sessions of sham tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.

Device: sham tDCS

Interventions

active tDCS DEVICE

The anode will be placed over the right DLPFC (F4 on the EEG 10-20 system) and the cathode over the left DLPFC65 (F3) using 25cm2 sponges at an intensity of 2mA. Stimulation will be delivered for 20 minutes via two saline-soaked surface sponge electrodes and a battery-driven, constant current stimulator (NeuroConn DC Stimulator Plus).

active tDCS

sham tDCS DEVICE

Same device and procedures as active tDCS with the exception that the device includes a study mode, in which subject-specific codes are entered to deliver active or sham stimulation, keeping the administrator blinded. Sham stimulation will use a method in which stimulation will be ramped up and back down over a 30-second period at the beginning and end of sham tDCS.

sham tDCS

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• current opioid dependence
• between 21-60 years of age
• recent initiation of buprenorphine or methadone (≤30days)
• 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.

You may not qualify if:

• current diagnosis of organic brain disorder (e.g., Parkinson's disease, Huntington's disease, multiple sclerosis, intracranial mass/infection, hydrocephalus)
• bipolar, schizophrenia, schizoaffective, or schizophreniform disorder, or current psychosis associated with any disorder
• current suicidality
• evidence of significant neurocognitive dysfunction
• 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
• probation/parole requirements or an upcoming move that might interfere with protocol participation
• planning to terminate buprenorphine or methadone in less than 3 months
• current pregnancy or plan to become pregnant in the next month.

Sponsors & Collaborators

• Butler Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Abrantes Abrantes, Ph.D.

  Butler Hospital

  PRINCIPAL INVESTIGATOR

• Michael Stein, M.D.

  Boston University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana M Abrantes, Ph.D.

CONTACT

4014556440; ana_abrantes@brown.edu

Julie A Desaulniers, M.S.

CONTACT

4014556219; jdesaulniers@butler.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 29, 2024
• Study Start: April 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: 1-year after the end of the study

Locations

US (1)