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Recruiting NCT07158853

Combined tDCS and Cognitive Training as an Adjunctive Treatment in Opioid Use Disorder

Phase I Interventional Opioid Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial Direct Current Stimulation (tDCS).
Who it may be relevant to
Registry conditions: Opioid Use Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The overall goal of this study is to investigate the added benefit of a neuromodulation intervention in individuals taking medication for treatment for Opioid Use Disorder(OUD).

Interventions

  • Device Transcranial Direct Current Stimulation (tDCS)
    We will deliver 2-mA tDCS current intensity during a 30 minute stimulation period (including a 30-second ramp-up and 30-second ramp-down period) to the dorsolateral prefrontal cortex. Electrodes will be fixed on marked locations based on the 10-20 EEG system. Anodal stimulating electrode will be over the left DLPFC (F3) and cathodal electrode over the right DLPFC (F4).

Primary outcome measures

  • tDCS effect on circuit-based target engagement of a prefrontal-incentive salience network [Time frame: immediately after the intervention]
  • tDCS effect on executive functioning [Time frame: immediately after the intervention]

Eligibility criteria

Inclusion criteria

  • Ability to provide consent and comply with study procedures
  • Diagnostic and Statistical Manual of Mental Disorders criteria for OUD
  • Undergoing medication treatment for OUD. Participants may have current comorbid drug use, but primary diagnosis must be OUD
  • Intention to remain in the study until intervention completion.

Exclusion criteria

  • Any medical condition with neurological sequelae
  • Head injury resulting in skull fracture or loss of consciousness of >30 minutes
  • Any tDCS or MRI contraindication (tDCS: history of seizures, metallic cranial plates/screws or implanted device, history of eczema on scalp. MRI: unapproved metallic implants, pacemakers or any other implanted electrical device, shrapnel, metallic braces, non-removable body piercings, pregnancy, breathing or movement disorder, or claustrophobia)
  • Any psychotic disorder (participants with other treated and stable psychiatric disorders will be included)
  • Presence of a condition that would render study measures impossible to administer or interpret
  • Age younger than 18
  • Primary current substance use disorder on a substance other than opioids except for caffeine or nicotine
  • In treatment instead of jail
  • Pregnancy
  • Disrespectful behavior towards the investigators and staff.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Minnesota — Minneapolis

Identifiers

NCT: NCT07158853 · PSYCH-2025-34164

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗