tDCS to Decrease Opioid Relapse (UG3)

Status Completed

Clinical Trial Summary

In the current proposal, the 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. Participants with opioid dependence, in the first month of prescribed buprenorphine or methadone, will be assessed twice using functional magnetic resonance imaging (FMRI) and electroencephalographic (EEG), once prior to tDCS+CCN priming and again at the completion of 5 sessions of tDCS+CCN priming (one week later). Task-based and resting state functional connectivity will be used to examine networks associated with craving (CR) and cognitive control. In Phase 1, FMRI and EEG will provide validation of expected changes in these networks following tDCS stimulation of the DLPFC.

Clinical Trial Description

This study has two phases. In phase one (UG3), the investigators propose to use FMRI to quantify changes in brain function and EEG to examine oscillatory brain changes as well as self-reported craving before and after administration of five sessions of tDCS+Cognitive Control Network (CCN) priming stimulation vs. sham tDCS+CCN priming (randomized control trial) in 60 opioid dependent participants who recently initiated buprenorphine or methadone. Participants in the first month of prescribed buprenorphine or methadone will be assessed using FMRI and EEG, once prior to tDCS and again one week later after completion of 5 sessions of tDCS+CCN priming. With a focus on the craving outcome, the investigators will use two task-based FMRI paradigms that challenge networks associated with craving (CR) and cognitive control (CCN), and will examine these and the salience network using resting state functional connectivity. In Phase 1, FMRI and EEG will be expected to provide 1) validation of expected network and oscillatory changes from tDCS-targeting and 2) an effect size for DLPFC vs sham stimulation. Go/no go criteria for the UG3 phase will be demonstration of greater FMRI change in any node of the CR or CCN networks or enhanced frontal theta power during a WM task AND greater change (at least 10% difference between conditions, controlling for baseline craving) in subjective craving measured during a cue reactivity task or outside the FMRI following the tDCS+CCN priming intervention compared to sham tDCS+CCN priming. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03842137
Study type	Interventional
Source	Butler Hospital
Contact
Status	Completed
Phase	N/A
Start date	June 4, 2019
Completion date	August 31, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.