Combined tDCS and Cognitive Training as an Adjunctive Treatment in Opioid Use Disorder
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- tDCS effect on circuit-based target engagement of a prefrontal-incentive salience network
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (Participant, Care Provider, Investigator)
盲法说明
Soterix Mini-CT Remote tDCS systems offer fully reliable researcher and participant blinding. Soterix Mini-CT Remote tDCS software interface allows for automatic generation of sham versions of the protocol. The system is run with a password-protected mode - minimizing information presented on the screen for definitive blinding of research staff and participants.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
tDCS
All intervention sessions will use the Soterix Mini-CT Remote tDCS device
干预措施: Transcranial Direct Current Stimulation (tDCS) (Device)
结局指标
主要结局
tDCS effect on circuit-based target engagement of a prefrontal-incentive salience network
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点