Status:
RECRUITING
Neuromodulation and Cognitive Training in Opioid Use Disorder
Lead Sponsor:
University of Minnesota
Conditions:
Opioid-use Disorder
Opioid Dependence
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The relapsing nature of opioid use disorder is a major obstacle to successful treatment. About 90% of those entering treatment will relapse within one year. To improve treatment outcome, new intervent...
Detailed Description
Cognitive flexibility, the ability to change maladaptive behavior, depends on dorsolateral prefrontal cortex (DLPFC) input to the nucleus accumbens (NAcc; Gruber, Hussain, and O'Donnell 2009). DLPFC s...
Eligibility Criteria
Inclusion
- 20 abstinent individuals (18-60 years old; 1-2 weeks of abstinence) who meet DSM-V criteria for opioid use disorder (OUD) will be recruited from the Lodging Plus Program, part of University of Minnesota Medical Center
- This 28-day program provides a supervised environment to treat individuals with OUD in which patients receive random drug screenings. Lodging Plus has 50 beds and admits an average of 20 patients per week and about 50% of patients admitted have a diagnosis of opioid use disorder.
- Ability to provide written consent and comply with study procedures, meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria for OUD. Subjects may have current comorbid drug use, but their primary substance use disorder diagnosis needs to be based on opioid use. Subjects must have the intention to remain in the Lodging Plus program (4 weeks) until the end of the intervention portion of the study. Vulnerable populations will not be included.
Exclusion
- Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness\>30 min, HIV)
- A 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: history of seizures; 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)
- DSM-V criteria for psychiatric disorder, may have a lifetime diagnosis of depression
- Presence of a condition that would render study measures difficult or impossible to administer or interpret
- Age outside the range of 18 to 60
- Primary current substance use disorder diagnosis on a substance other than opioid except for caffeine or nicotine
- Clinical evidence for Wernicke-Korsakoff syndrome
- Nicotine use will be recorded.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03773523
Start Date
August 1 2019
End Date
May 15 2026
Last Update
June 12 2025
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55414