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Combining Neuro-Imaging and Non-Invasive Brain Stimulation for Clinical Intervention in Opioid Use Disorder

Recruiting

This study will enroll adults who are currently in a methadone treatment program and clinically stable in a randomized, double-blind, transcranial direct current stimulation (tDCS) intervention (active or sham) trial study. The primary study aim seeks to examine whether pairing non-invasive brain stimulation technique called transcranial direct current stimulation (tDCS) with cognitive training, as a therapeutic intervention can enhance cognition and reduce relapse rates in opioid use disorder. The long term goal is to develop new addiction treatments that support long-term abstinence in opioid use disorder.

I'm interested

All
18 Years to 60 Years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Current diagnosis of opioid use disorder
• Enrolled in a methadone treatment program for at least 2 months in Hennepin Healthcare and be clinically stable.
• Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria for opioid use disorder
• Participants may have current comorbid drug use, but their primary substance use disorder diagnosis must to be based on opioid use.
• Participants must have the intention to remain in the methadone treatment program until the end of the intervention portion of the study.
Exclusion Criteria:

• Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness>30 min, HIV)
• Head injury resulting in a skull fracture or a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI)
• Any contraindications for tDCS or MRI scanning (tDCS contraindication: actively receiving treatment for seizures or epilepsy; MRI contraindications; metal implants, pacemakers or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or moving disorder)
• Current active psychosis or mania
• Presence of a condition that would render study measures difficult or impossible to administer or interpret (e.g. current mania, active psychosis)
• Primary current substance use disorder diagnosis on a substance other than opioid except for caffeine or nicotine
• Current stimulant use disorder (need to be free of stimulant use for at least 1 month)
• History of electroconvulsive therapy or cortical energy exposure within the past 12 months, including participation in any other neuromodulation studies
• incarceration

Device: Transcranial Direct Current Stimulation (tDCS), Device: Sham Transcranial Direct Current Stimulation (tDCS), Behavioral: Cognitive Training

Opioid-Related Disorders, Heroin Dependence, Morphine Dependence

Lisa Keacher - keach003@umn.edu
N/A
NCT04495673
See this study on ClinicalTrials.gov

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