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

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Not yet enrolling

Conditions

Buprenorphine
Opioid Use Disorder

Treatments

Device: Transcranial Direct Current Stimulation (tDCS)
Device: Sham Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT07158853
PSYCH-2025-34164

Details and patient eligibility

About

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).

Enrollment

160 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

160 participants in 2 patient groups, including a placebo group

tDCS
Active Comparator group
Description:
All intervention sessions will use the Soterix Mini-CT Remote tDCS device
Treatment:
Device: Transcranial Direct Current Stimulation (tDCS)
Sham Electrodes
Placebo Comparator group
Treatment:
Device: Sham Stimulation

Trial contacts and locations

1

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Central trial contact

Clarista Berg

Data sourced from clinicaltrials.gov

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