Opioid Use Disorder
Conditions
Brief summary
The overall goal of this study is to investigate the added benefit of a neuromodulation intervention in individuals taking medication for treatment for Opioid Use Disorder(OUD).
Interventions
DEVICETranscranial Direct Current Stimulation (tDCS)
We will deliver 2-mA tDCS current intensity during a 30 minute stimulation period (including a 30-second ramp-up and 30-second ramp-down period) to the dorsolateral prefrontal cortex. Electrodes will be fixed on marked locations based on the 10-20 EEG system. Anodal stimulating electrode will be over the left DLPFC (F3) and cathodal electrode over the right DLPFC (F4).
Sponsors
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to provide consent and comply with study procedures * Diagnostic and Statistical Manual of Mental Disorders criteria for OUD * Undergoing medication treatment for OUD. Participants may have current comorbid drug use, but primary diagnosis must be OUD * Intention to remain in the study until intervention completion.
Exclusion criteria
* Any medical condition with neurological sequelae * Head injury resulting in skull fracture or loss of consciousness of \>30 minutes * Any tDCS or MRI contraindication (tDCS: history of seizures, metallic cranial plates/screws or implanted device, history of eczema on scalp. MRI: unapproved metallic implants, pacemakers or any other implanted electrical device, shrapnel, metallic braces, non-removable body piercings, pregnancy, breathing or movement disorder, or claustrophobia) * Any psychotic disorder (participants with other treated and stable psychiatric disorders will be included) * Presence of a condition that would render study measures impossible to administer or interpret * Age younger than 18 * Primary current substance use disorder on a substance other than opioids except for caffeine or nicotine * In treatment instead of jail * Pregnancy * Disrespectful behavior towards the investigators and staff.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tDCS effect on circuit-based target engagement of a prefrontal-incentive salience network | immediately after the intervention | To assess changes in target engagement, we will measure the change in resting-state functional connectivity (measured as a Pearson correlation coefficient, r) between the prefrontal cortex and the incentive salience network from pre- to post-intervention using a paired t-test. The connectivity metric ranges from a minimum value of -1.0 (perfectly negative correlation) to a maximum value of 1.0 (perfectly positive correlation). Higher scores indicate stronger functional connectivity (greater top-down regulation), representing a better outcome. |
| tDCS effect on executive functioning | immediately after the intervention | To assess changes in executive functioning, we will measure the change in executive functioning from pre- to post-intervention using a repeated measures t-test. Cognitive performance will be assessed via a behavioral battery spanning cognitive flexibility, working memory, inhibitory control, and delay discounting (utilizing standardized Pearson assessments and a computerized delay discounting task). Performance metrics across tasks will be converted to standardized z-scores (typically ranging from -3.0 to +3.0). The primary endpoint is the post-intervention mean z-score minus the pre-intervention mean z-score. A positive change score indicates an increase in executive functioning, representing a better clinical outcome. |
Countries
United States
Contacts
CONTACTCalvin Cahill
PRINCIPAL_INVESTIGATORJazmin Camchong, PhD
University of Minnesota
Outcome results
None listed