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

Not Applicable

Not yet recruiting

• Conditions: Opioid Use Disorder; Buprenorphine

• Registration Number: NCT07158853
• Lead Sponsor: University of Minnesota

Brief Summary

The overall goal of this study is to investigate the added benefit of a neuromodulation intervention in individuals under buprenorphine maintenance treatment for OUD (bOUD).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-11
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-02
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Study Start: 2025-11-01
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• ability to provide consent and comply with study procedures
• Diagnostic and Statistical Manual of Mental Disorders criteria for OUD
• undergoing buprenorphine maintenance treatment. Participants may have current comorbid drug use, but primary diagnosis must be OUD
• Intention to remain in the addiction treatment program 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
• court mandated treatment
• pregnancy
• disrespectful behavior towards the investigators and staff.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
tDCS effect on circuit-based target engagement of a prefrontal-incentive salience network	immediately after the intervention	Compare change in correlation value (which represents the functional connectivity between pre-frontal cortex and prefrontal-incentive salience network) via paired t-test, from pre- to post-intervention
tDCS effect on executive functioning	immediately after the intervention	Compare change in mean cognitive performance via paired t-test from pre-intervention cognitive assessment to post-intervention cognitive assessment (post-intervention mean cognitive score minus pre-intervention mean cognitive score) between active tDCS and sham groups

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States