Helping Kentuckians Overcome Depression and Opioid Addiction With Brain Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Depressive Symptom Severity
研究概览
简要总结
This study will compare transcranial magnetic stimulation (TMS) with sham TMS in people with opioid use disorder who are taking buprenorphine and have major depressive disorder with ongoing depressive symptoms. The study will evaluate whether TMS improves depressive symptoms and reduces opioid craving. The study will also assess smoking behaviors, treatment acceptability, and any side effects related to TMS.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years of age
- •Willing and able to provide informed consent
- •Able to read and speak english
- •Opioid use disorder, in remission for at least a month
- •Diagnosis of major depressive disorder confirmed with the Mini-International Neuropsychiatric Interview (MINI, 7.02)
- •Minimum score of 10 on the 17-item Hamilton Depression Rating Scale (HDRS-17)
- •Opioid craving score of 5 or greater on a 0-10 scale
- •Stabilized on sublingual or depot buprenorphine for at least 8 weeks
排除标准
- •Seizure disorder
- •any other acute medical or behavioral disorder that would preclude safe participation
- •Pregnant, nursing or planning to become pregnant during the study
- •Magnetic resonance imaging (MRI) contraindications, including ferrous retainers, intracranial implants, or claustrophobia
- •Surgical procedure planned during the study period
- •Any other medical condition that could compromise participant well-being
研究组 & 干预措施
Transcranial Magnetic Stimulation (TMS)
Participants will receive active transcranial magnetic stimulation (TMS) using intermittent theta burst stimulation (iTBS).
干预措施: Transcranial Magnetic Stimulation (TMS) (Device)
Sham Transcranial Magnetic Stimulation (TMS)
Participants will receive sham transcranial magnetic stimulation (TMS) using the same treatment procedure without a significant electric field induced around the brain.
干预措施: Sham Transcranial Magnetic Stimulation (TMS) (Device)
结局指标
主要结局
Change in Depressive Symptom Severity
时间窗: Baseline through Week 13
Change in depressive symptom severity as measured by the 17-item Hamilton Depression Rating Scale (HDRS-17) from baseline, comparing participants receiving transcranial magnetic stimulation (TMS) with those receiving Shame TMS. Higher scores indicate greater depressive symptom severity. The HDRS-17 ranges from 0-52.
Change in Opioid Craving
时间窗: Baseline through Week 13
Change in opioid craving as measured by the Opioid Craving Scale (OCS) from baseline, comparing participants receiving the TMS with those receiving sham TMS. The OCD consists of three items rated 0 to 10, with the total score calculated as the average of the three items. A higher score indicates greater opioid craving.
次要结局
未报告次要终点
研究者
Gopalkumar Rakesh
Associate Professor
University of Kentucky