Using brain stimulation and cognitive training to help treat substance use disorders
Neuromodulation and Cognitive Training for Substance Use Disorders
This study is testing a new way to help people who have recently stopped using drugs or alcohol by combining brain stimulation with cognitive training to see if it can reduce the chances of relapse.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT04426214 on ClinicalTrials.gov |
What this trial studies
This study aims to address the high relapse rates associated with substance use disorders by testing a novel intervention that combines transcranial direct current stimulation (tDCS) with cognitive training. The approach focuses on engaging specific brain biomarkers linked to relapse vulnerability to enhance cognitive function and improve treatment outcomes. Participants will be individuals who have recently abstained from substance use, and the study will monitor changes in brain activity and cognitive performance throughout the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 to 65 who have been abstinent from substances for at least three weeks and meet the diagnostic criteria for stimulant use disorder or alcohol use disorder.
Not a fit: Patients who have been abstinent for over nine months or have a primary substance use disorder diagnosis other than stimulant or alcohol may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce relapse rates and improve long-term recovery outcomes for individuals with substance use disorders.
How similar studies have performed: Other studies have shown promise in using neuromodulation techniques for treating substance use disorders, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota Fairview — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Kelvin Lim, MD — University of Minnesota
- Study coordinator: Melanie Stimac
- Email: stima011@umn.edu
- Phone: 612-301-2449
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.