NCT04426214 Neuromodulation and Cognitive Training for Substance Use Disorders
| NCT ID | NCT04426214 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Stimulant Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2021-07-16 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2021-07-16 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The relapsing nature of substance use disorder is a major obstacle to successful treatment. About 70% 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. This study is testing a new intervention, namely tDCS-Augmented Cognitive Training, to engage these brain biomarkers to improve cognition and improve treatment outcomes.
Eligibility Criteria
Inclusion Criteria: * Abstinent from any substance or alcohol use (excluding caffeine or nicotine) for a minimum of 3 weeks at study enrollment * Has the intention to remain in their treatment program(s) until the end of the intervention portion of the study. * Able to provide written consent and comply with study procedures. * Meets the MINI 7 diagnostic criteria for either stimulant use disorder (SUD) or alcohol use disorder (AUD). Exclusion Criteria: * Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, HIV) * Over 9 months of abstinence from substance use * A head injury resulting in a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI) * Presence of a condition that would render study measures difficult or impossible to administer or interpret * Age outside the range of 18 to 65 * Primary current substance use disorder diagnosis (according to MINI 7 diagnostic criteria) for a substance other than stimulant or alcohol, except for caffeine or nicotine (Nicotine use will be recorded but is not exclusionary) * Entrance to the treatment program under a court mandate. (i.e. legally incarcerated) * History of ECT or cortical energy exposure within the past 6 months, including participation in any other neuromodulation studies
Contact & Investigator
Kelvin Lim, MD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT04426214 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Stimulant Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04426214 currently recruiting?
Yes, NCT04426214 is actively recruiting participants. Contact the research team at stima011@umn.edu for enrollment information.
Where is the NCT04426214 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT04426214 clinical trial?
NCT04426214 is sponsored by University of Minnesota. The principal investigator is Kelvin Lim, MD at University of Minnesota. The trial plans to enroll 80 participants.