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RECRUITING
NCT06432465
NA

tDCS to Decrease Opioid Relapse (UH3)

Sponsor: Butler Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

21 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-04-17

Completion Date

2026-12-31

Last Updated

2024-12-04

Healthy Volunteers

No

Interventions

DEVICE

active tDCS

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).

DEVICE

sham tDCS

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.

Locations (1)

Butler Hospital

Providence, Rhode Island, United States