Repetitive Transcranial Magnetic Stimulation for Suicidality in Opioid Use Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Scale for Suicidal Ideation Remission
研究概览
简要总结
This trial is a randomized, double blind, controlled pilot study that will compare bilateral theta burst stimulation (TBS) and sham treatment for patients with opioid use disorder (OUD) and Major Depressive Disorder (MDD) experiencing suicidality.
详细描述
Repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC) is used therapeutically in major depressive disorder resistant to standard treatments, and recently also shown to be effective in reducing suicidality with a bilateral approach. Recently, a new form of rTMS has been developed called theta burst stimulation (TBS) which requires a much shorter daily treatment duration and has been found to be non-inferior to standard rTMS. The investigators propose to conduct a randomized controlled clinical trial of a daily, 20 session course of bilateral TBS versus sham stimulation in the treatment of suicidality in patients with OUD and MDD. The investigators will explore whether TBS can have other clinical effects on decreasing symptoms of MDD, craving for opioids, and rates of relapse to opioid use. The investigators will also examine whether rTMS can engage GABA mediated inhibition using combined transcranial magnetic stimulation and electroencephalography (TMS-EEG) will be assessed before and after intervention. Clinical outcomes measured before, during, at end of treatment, and 4-weeks post treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Capable of providing informed consent and research procedures according to the brain stimulation attending psychiatrist
- •Between the ages of 18-60 years
- •Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of Opioid Dependence and MDD.
- •On a stable treatment regimen without any change in opioid agonist or antidepressant medications or dosages in the last 30 days. Participants will be asked not to change their medication regimen for the duration of the study.
- •Baseline score of >/=4 on the scale for suicidal ideation (SSI).
排除标准
- •Currently pregnant or intending to be pregnant during the duration of the study
- •Bipolar disorder, any psychotic disorder or current psychotic symptoms
- •Previous rTMS treatment
- •Known active seizure disorder, significant head injury with an imaging verified lesion
- •Unstable medical illness
- •Presence of cardiac pacemaker, intracranial implant, or metal in the cranium
- •Participants taking > 2 mg lorazepam (or a benzodiazepine at an equivalent dose) or taking any anticonvulsant medication during treatment.
研究组 & 干预措施
Active TBS
Daily, 4-week, 5-days per week treatment sessions, each consisting of:
First, intermittent TBS (iTBS) over the L-DLPFC: triplet 50 Hz bursts, repeated at 5 Hz, 2 s on and 8 s off, (600 pulses per session, total duration of 3 min 9 s), then continuous TBS (cTBS) over the R-DLPFC as 40 s uninterrupted bursts (600 pulses). Intensity at 120% resting motor threshold (RMT).
干预措施: Active TBS (Device)
Sham TBS
Daily, 4-week, 5-days per week treatment sessions. The sham coil will generate auditory and somatosensory (vibratory) stimuli identical to the active stimulation.
干预措施: Sham TBS (Device)
结局指标
主要结局
Change in Scale for Suicidal Ideation Remission
时间窗: Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
A semi-structured interview for assessing suicidal ideation, min value=0, max value = 38. Higher score = worse outcome.
次要结局
- Change in Scale for Suicidal Ideation Change(Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up)
- Change in Columbia - Suicide Severity Rating Scale Change(Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up)
- Timeline Followback Change(Baseline, after TBS treatment course (4 weeks), and at 1 month follow up)
- Visual Analogue Scale for Opioid Cravings Change(Baseline, after TBS treatment course (4 weeks), and at 1 month follow up)
- 17-item Hamilton Rating Scale for Depression (HRSD-17) Change(Baseline, after TBS treatment course (4 weeks), and at 1 month follow up)