Status:
TERMINATED
Combining Neuro-Imaging and Non-Invasive Brain Stimulation for Clinical Intervention in Opioid Use Disorder
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid-Related Disorders
Heroin Dependence
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The overarching goal of this project is to expand the traditional expertise in non-invasive neuromodulation at the University of Minnesota towards developing novel paired-neuromodulation approaches us...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04495673
Start Date
January 11 2021
End Date
February 22 2022
Last Update
July 10 2025
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455