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NCT Number: NCT07158853

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

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Calvin Cahill

CONTACT

[email protected]

952-444-0137

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

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 outcomes

  1. tDCS effect on circuit-based target engagement of a prefrontal-incentive salience network

    Time frame: immediately after the intervention

    To assess changes in target engagement, we will measure the change in resting-state functional connectivity (measured as a Pearson correlation coefficient, r) between the prefrontal cortex and the incentive salience network from pre- to post-intervention using a paired t-test. The connectivity metric ranges from a minimum value of -1.0 (perfectly negative correlation) to a maximum value of 1.0 (perfectly positive correlation). Higher scores indicate stronger functional connectivity (greater top-down regulation), representing a better outcome.

  2. tDCS effect on executive functioning

    Time frame: immediately after the intervention

    To assess changes in executive functioning, we will measure the change in executive functioning from pre- to post-intervention using a repeated measures t-test. Cognitive performance will be assessed via a behavioral battery spanning cognitive flexibility, working memory, inhibitory control, and delay discounting (utilizing standardized Pearson assessments and a computerized delay discounting task). Performance metrics across tasks will be converted to standardized z-scores (typically ranging from -3.0 to +3.0). The primary endpoint is the post-intervention mean z-score minus the pre-intervention mean z-score. A positive change score indicates an increase in executive functioning, representing a better clinical outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Calvin Cahill

CONTACT

[email protected]

952-444-0137

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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