An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 主要终点
- rTMS reduces substance use
研究概览
简要总结
The purpose of this study is to understand the role of repetitive Transcranial Magnetic Stimulation (rTMS) in reducing opioid and other substance use and craving and improving thinking skills.
详细描述
The overarching goal of this study is to investigate a form of neuromodulation, rTMS, as an adjunctive treatment for OUD by evaluating the impact of rTMS on substance use, craving and inhibitory control, factors which contribute to relapse. The primary outcome will be the assessment of whether rTMS reduces substance use. Additional exploratory outcomes include the assessment of whether rTMS applied to the DLPFC provides neuromodulatory effects through the assessment of craving, inhibitory control, and functional connectivity via MRI. The targeted sample size for this open-label study, where all enrolled subjects will receive 9 sessions of active rTMS over 3 weeks.
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
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent, and to comply with study procedures.
- •Be actively enrolled in the COAT Program
- •Meet DSM-V criteria for a primary OUD assessed via structured clinical interview
- •Columbia-Suicide Severity Rating Scale score < 4
- •Be abstinent from opioids (other than prescribed buprenorphine/naloxone) and illicit substances other than marijuana at the time of the enrollment, confirmed via urine drug screen
- •Willing to practice contraception to avoid pregnancy the duration of the study
排除标准
- •Medical conditions that preclude rTMS: including vasodepressor syncope, glaucoma, increased intracranial pressure, cardiac disease, migraine disorder, cerebral vascular events (cerebral vascular accident, transient ischemic attack), any brain lesions (such multiple sclerosis), brain injury, seizure disorder (or family history) of any type, and have cardiac pacemakers or implanted medication pumps
- •DSM-V criteria for major psychiatric illness other than depression
- •Major Cognitive Disorder (as evidenced by a score of <21/30 on the Mini Mental Status Exam (MMSE)
- •Pregnancy
- •Positive responses to the TMS Adult Safety Screen or the MRI checklist
- •Intracranial metallic objects (excluding dental fillings)
- •Uncorrected visual acuity problems
- •Mobility limitations
- •Clinically significant EKG abnormalities (including QTc interval prolongation >450 ms in men or >480 ms in women)
- •Unwillingness to abstain from prescribed drugs
- •Prior rTMS treatment
- •Other mental or physical conditions that, in the PI's opinion, would be inappropriate for study participation.
- •Intake of one or a combination of the following drugs forms a 'Strong Potential Hazard' for application of rTMS due to their significant seizure threshold lowering potential:
- •Imipramine, Amitriptyline, Doxepine, Nortriptyline, Maprotiline, Chlorpromazine, Clozapine, Foscarnet, Ganciclovir, Ritonavir, Amphetamines, Cocaine (MDMA, ecstasy), Phencyclidine (PCP, angel's dust), Ketamine, Gamma-hydroxybutyrate (GHB), Alcohol, Theophylline.
- •The inclusion of a patient on any of the above medication will be carefully evaluated and a decision documented by the medically responsible physician. The risk is dependent on the patient's past medical history, drug dose, speed of dose increase (or decrease), history of recent medication changes or duration of treatment, and combination with other CNS active drugs.
- •Recent withdrawal from one of the following drugs forms a 'Strong Relative Hazard' for application of rTMS due to the resulting significant seizure threshold lowering potential:
- •Alcohol, Barbiturates, Benzodiazepines, Meprobamate, Chloral hydrate
结局指标
主要结局
rTMS reduces substance use
时间窗: 1 - 7 weeks
Opioid use as measured by quantitative urine toxicology via high pressure liquid chromatography at screening, baseline, enrollment (3 times per week for 3 weeks), and follow-up phases (weekly for 4 weeks).
次要结局
- rTMS applied to the DLPFC provides neuromodulatory effects(1 - 7 weeks)
研究者
James Mahoney
Assistant Professor/Clinical Neuropsychologist
West Virginia University