Neuromodulation and Cognitive Training for Substance Use Disorders
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2020
CompletedFirst Posted
Study publicly available on registry
June 11, 2020
CompletedStudy Start
First participant enrolled
July 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
August 26, 2025
August 1, 2025
5.1 years
May 29, 2020
August 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent of participants with clean drug screens
2 months
Study Arms (2)
Active tDCS
EXPERIMENTALSham tDCS
PLACEBO COMPARATORInterventions
We will apply tDCS in combination with cognitive training. All participants receive cognitive training, and will be randomized to receive either active or sham tDCS
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota Fairview
Minneapolis, Minnesota, 55454, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kelvin Lim, MD
University of Minnesota
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2020
First Posted
June 11, 2020
Study Start
July 16, 2021
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
August 26, 2025
Record last verified: 2025-08