RecruitingNot ApplicableNCT03773523

Neuromodulation and Cognitive Training in Opioid Use Disorder


Sponsor

University of Minnesota

Enrollment

30 participants

Start Date

Aug 1, 2019

Study Type

INTERVENTIONAL

Conditions

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 interventions targeting the underlying brain biomarkers of relapse vulnerability hold significant promise in reducing this critical public health problem. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that can modulate brain connectivity.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This University of Minnesota study is testing whether a combination of transcranial direct current stimulation (tDCS) — a non-invasive brain stimulation technique — and cognitive training can help people with opioid use disorder (OUD) improve their decision-making and self-control during early abstinence. The study enrolls people in a 28-day residential recovery program who are in their first 1–2 weeks of abstinence from opioids. You may be eligible if: - You are between 18 and 60 years old - You meet DSM-5 criteria for opioid use disorder as your primary substance use disorder - You have been abstinent from opioids for 1–2 weeks - You are enrolled in the Lodging Plus residential program at the University of Minnesota Medical Center - You plan to remain in the program for the full 4 weeks You may NOT be eligible if: - You have a neurological condition (stroke, brain tumor, significant head injury with >30 min loss of consciousness, HIV-related neurological issues) - You have contraindications to tDCS or MRI (history of seizures, metal implants, pacemakers, pregnancy, braces, non-removable piercings) - You have a current (not lifetime) DSM-5 psychiatric disorder (except depression history) - Your primary substance use disorder is something other than opioids (caffeine and nicotine are acceptable) - You are outside the age range of 18–60 Talk to your addiction medicine provider about whether this brain stimulation and cognitive training study is appropriate during your current recovery program.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscranial Direct Current Stimulation (tDCS)

tDCS will be performed with Neuroelectrics Starstim Enobio 20, a non-invasive investigational device that has been labeled as a non-significant risk device by the FDA. This study is regulated by the FDA as an Abbreviated IDE. It has built-in safety mechanisms which allow for immediate cessation of stimulation if the subject becomes uncomfortable. The current will be administered via two electrode sponges for 25 mins with 1-2 milliamperes. These administration protocols are in line with protocols that have outlined safe administration (Nitsche 2007; 2008). No side-effects have been reported with the exception of slight itching under the electrode and occasional occurrence of headache, fatigue, or nausea (Poreisz 2007). Electrodes placement: dorsolateral prefrontal cortex (DLPFC); cathode on left DLPFC, anode on right DLPFC.


Locations(1)

University of Minnesota

Minneapolis, Minnesota, United States

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NCT03773523


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