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tDCS to Decrease Opioid Relapse (UH3)

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Site contact updated
    • Eligibility criteria expanded, about 1 word
    v4
  2. Interventions: tDCS (Device) to active tDCS (Device), sham tDCS (Device)v3
  3. Primary endpoints: 3 to 1
    • Eligibility criteria shortened, about 13 words
    • Secondary endpoints expanded, about 5 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Butler Hospital
30 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT06432465
Lead Sponsor Butler Hospital
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions
(from sponsor)		 Opioid Use Disorder
Related terms Opioid-Related Disorders
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov