概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Opioid Dependence
- 发起方
- Butler Hospital
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Opioid Craving
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
In the current proposal, the investigators will measure behavioral and brain responses following transcranial direct current stimulation (tDCS) to the dorsolateral prefrontal cortex (DLPFC) (anode on right DLPFC, cathode on the left DLPFC) delivered during cognitive control network (CCN) priming. Participants with opioid dependence, in the first month of prescribed buprenorphine or methadone, will be assessed twice using functional magnetic resonance imaging (FMRI) and electroencephalographic (EEG), once prior to tDCS+CCN priming and again at the completion of 5 sessions of tDCS+CCN priming (one week later). Task-based and resting state functional connectivity will be used to examine networks associated with craving (CR) and cognitive control. In Phase 1, FMRI and EEG will provide validation of expected changes in these networks following tDCS stimulation of the DLPFC.
详细描述
This study has two phases. In phase one (UG3), the investigators propose to use FMRI to quantify changes in brain function and EEG to examine oscillatory brain changes as well as self-reported craving before and after administration of five sessions of tDCS+Cognitive Control Network (CCN) priming stimulation vs. sham tDCS+CCN priming (randomized control trial) in 60 opioid dependent participants who recently initiated buprenorphine or methadone. Participants in the first month of prescribed buprenorphine or methadone will be assessed using FMRI and EEG, once prior to tDCS and again one week later after completion of 5 sessions of tDCS+CCN priming. With a focus on the craving outcome, the investigators will use two task-based FMRI paradigms that challenge networks associated with craving (CR) and cognitive control (CCN), and will examine these and the salience network using resting state functional connectivity. In Phase 1, FMRI and EEG will be expected to provide 1) validation of expected network and oscillatory changes from tDCS-targeting and 2) an effect size for DLPFC vs sham stimulation. Go/no go criteria for the UG3 phase will be demonstration of greater FMRI change in any node of the CR or CCN networks or enhanced frontal theta power during a WM task AND greater change (at least 10% difference between conditions, controlling for baseline craving) in subjective craving measured during a cue reactivity task or outside the FMRI following the tDCS+CCN priming intervention compared to sham tDCS+CCN priming.
研究者
入排标准
入选标准
- •current opioid dependence
- •between 21-50 years of age
- •recent initiation of buprenorphine or methadone (\<30 days)
排除标准
- •current criteria for a DSM-V diagnosis of bipolar disorder, schizophrenia, schizo-affective, schizophreniform, or paranoid disorder
- •current suicidality
- •evidence of neurocognitive dysfunction
- •contraindications for tDCS (e.g seizure disorder)
- •probation/parole requirements or an upcoming move that might interfere with protocol participation
- •planning to terminate buprenorphine in less than 3 months
- •scalp lesions near the tDCS electrode sites
- •Exclusion Criteria related to FMRI scanning are:
- •history of neurological disorder (e.g., epilepsy, stroke, brain injury with loss of consciousness\>10 min)
- •impaired uncorrected vision
结局指标
主要结局
Opioid Craving
时间窗: 2 week
Penn Alcohol Craving (Modified for Opioids). This is a 5-item measure, with each item scored 0 to 6. Items are summed for a total score from 0 to 30. Higher scores = more craving.
次要结局
- EEG Theta Brainwave Activity(2 weeks)