Using brain stimulation and cognitive training to help with opioid use disorder
Neuromodulation and Cognitive Training in Opioid Use Disorder
This study is testing if brain stimulation combined with cognitive training can help people with opioid use disorder feel less cravings and improve their treatment outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT03773523 on ClinicalTrials.gov |
What this trial studies
This study aims to improve treatment outcomes for individuals with opioid use disorder by utilizing transcranial direct current stimulation (tDCS) to stimulate the dorsolateral prefrontal cortex (DLPFC). The approach focuses on enhancing cognitive flexibility and reducing cravings by modulating brain connectivity. A total of 30 participants will be enrolled, with half receiving active tDCS and the other half receiving sham stimulation over five sessions. Participants will undergo MRI scans and clinical assessments before and after the intervention to evaluate its effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 who have been abstinent for 1-2 weeks and meet DSM-V criteria for opioid use disorder.
Not a fit: Patients who are not currently abstinent or do not have a primary diagnosis of opioid use disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce relapse rates in individuals with opioid use disorder.
How similar studies have performed: While the use of tDCS in substance use disorders is still emerging, preliminary studies have shown promise in similar approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Jazmin Y Camchong, PhD — University of Minnesota
- Study coordinator: Jazmin Y Camchong, PhD
- Email: camch002@umn.edu
- Phone: (612) 624-0134
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.