Effects of Noninvasive Brain Stimulation Methods (rTMS and tDCS) Treatment on Brain Function, Craving and Relapse Prevention
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in craving and opioid relapse Using Opioid Cue panel
研究概览
简要总结
Addiction is known as a chronic relapsing brain disorder that has a high cost to patients, family and society. Its ranking in cause of death is 8th globally, and substance abuse contributes 5.4% of the total global burden of disease. Brain stimulation procedures such as repetitive trans-cranial magnetic stimulation (rTMS) and trans-cranial direct current stimulation (tDCS) are considered minimal risk interventions and are used for the treatment of depression, pain, and other neurological and psychiatric disorders. There is some evidence that rTMS applied to the left prefrontal cortex results in significantly lowered craving. To date, no studies have investigated the effects of a course of either rTMS or tDCS treatment on opioid craving, brain function, and relapse prevention in opioid addicts. Individuals with prescription opioid dependence experience high rates of desire and intense cravings to use opioids. The present study aims to examine the effects of a course of daily prefrontal rTMS and tDCS on brain function, desire and craving and help to relapse prevention in abstinence phase.
详细描述
The investigators plan to compare and contrast TMS and tDCS alone or in combination to treat opioid abuse. We will use a 4 cell randomised parallel controlled trial, consisting of active or sham TMS, and active or sham tDCS [a-tDCS, a-TMS; s-tDCS, a-TMS; a-tDCS, s-TMS; s-tDCS, s-TMS). The investigators hypothesise that each of the active interventions alone will be superior to pure sham in reducing craving and use. Moreover, The investigators hypothesise that COMBINING the two active treatments will be synergistic and will produce the largest reductions in craving and use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 treatment-seeking opioid-dependent subjects (between the ages of 21 and 65) with at least 30 days of abstinence under maintenance treatment will be included in this single blind study.
- •Exclusion criteria includes:
- •history of seizures,
- •receiving any medications known to lower seizure threshold,
- •pregnancy,
- •metal implants above the waist,
- •brain lesions or tumors,
- •a history of negative reactions to TMS, and
- •a positive opioid urine screen (except methadone and suboxone
排除标准
- 未提供
研究组 & 干预措施
20 min active tDCS, and 20 min active rTMS
Applying active tDCS AND active TMS will reduce cue induced craving and opioid use, more than sham TMS AND sham tDCS and also either active TMS OR active tDCS alone. We will apply 10 daily sessions of brain stimulation (1 hour total treatment time). This is composed of 20 minutes active tDCS (anode on F3 EEG positioning and cathode on contra shoulder), followed by 4000 pulses of real rTMS (10Hz over left Dorsolateral Prefrontal Cortex(DLPFC) for 20 minutes at 120%MT). There will be 10 minutes rest between each module. We will test for cue-induced craving scores using VAS and urine drug screens for opioid abuse in comparison to the control group of sham TMS AND sham tDCS and the groups with only active tDCS OR active TMS.
干预措施: Brain Stimulation (Device)
20 min sham tDCS, and 20 min active rTMS
Applying sham tDCS AND active TMS will reduce cue induced craving and opioid use, more than will sham TMS AND sham tDCS. We will apply 10 daily sessions of brain stimulation (1 hour total treatment time). This is composed of with 20 minutes sham tDCS (anode on F3 EEG positioning and cathode on contra shoulder), and 4000 pulses of real rTMS with (10Hz over left DLPFC for 20 minutes at 120%MT. There will be 10 minutes rest between each module. We will test for cue-induced craving scores using VAS and urine drug screens for opioid abuse in comparison to the control group of sham TMS AND sham tDCS.
干预措施: Brain Stimulation (Device)
20 min active tDCS, and 20 min sham rTMS
Applying active tDCS AND sham TMS will reduce cue induced craving and opioid use, more than will sham TMS AND sham tDCS. We will apply 10 daily sessions of brain stimulation (1 hour total treatment time). This is composed of with 20 minutes active tDCS (anode on F3 EEG positioning and cathode on contra shoulder), and 4000 pulses of sham rTMS with (10Hz over left DLPFC for 20 minutes at 120%MT. There will be 10 minutes rest between each module. We will test for cue-induced craving scores using VAS and urine drug screens for opioid abuse in comparison to the control group of sham TMS AND sham tDCS.
干预措施: Brain Stimulation (Device)
20 min sham tDCS, and 20 min sham rTMS
Applying sham tDCS AND sham TMS will not reduce cue induced craving and opioid use. We will apply 10 sessions of one hour of brain stimulation. We will apply 10 daily sessions of brain stimulation (1 hour total treatment time). This is composed of with 20 minutes sham tDCS (anode on F3 EEG positioning and cathode on contra shoulder), and 4000 pulses of sham rTMS with (10Hz over left DLPFC for 20 minutes at 120%MT. There will be 10 minutes rest between each module. We will test for cue-induced craving scores using VAS and urine drug screens for opioid abuse in comparison to the control group of sham TMS AND sham tDCS.
干预措施: Brain Stimulation (Device)
结局指标
主要结局
Change in craving and opioid relapse Using Opioid Cue panel
时间窗: Day 1, 6 month
Using Opioid Cue panel
次要结局
未报告次要终点