Evaluating Repetitive Transcranial Magnetic Stimulation to Reduce Opioid Cravings in Adults Who Use Heroin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Desires for Drug Questionnaire
研究概览
简要总结
The purpose of this research study is to test the effect of repetitive transcranial magnetic stimulation (rTMS) on opioid cravings among adult patients with Opioid Use Disorder.
详细描述
This study will use rTMS, a neuromagnetic and non-invasive treatment, to reduce opioid cravings in individuals who are diagnosed with opioid use disorder. Repetitive transcranial magnetic stimulation is currently used for the treatment of Major Depressive Disorder and Obsessive Compulsive Disorder in clinical practice. This proposed study will employ a randomized, single-blind, experimental design. Participants will be randomly assigned to two groups using a computer-based randomization program: treatment and sham-control groups.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult aged 18-64, used heroin in the past 30 days;
- •has a history of heroin use for at least one year;
- •meets the clinical criteria for Opioid Use Disorder (only heroin use will be considered to meet this criteria);
- •meets the clinician clearance using the rTMS Patient Screening Form.
排除标准
- •do not currently take and medications for a substance use disorder such as methadone, buprenorphine, naltrexone, acamprosate, disulfiram;
- •do not have a psychotic disorder;
- •do not have a diagnosis of another substance use disorder;
- •do not have a history of seizures or other neurological disorders including organic brain disease; epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery;
- •do not have a personal history of head trauma that resulted in a loss of consciousness for more than 5 minutes and retrograde amnesia for more than 30 minutes;
- •do not have a presence of non-fixed metal in body 30 cm to treatment coil.
- •have not taken any medication for a substance use disorder within the last 72 hours before the first rTMS treatment;
- •are not pregnant or think you may be pregnant.
结局指标
主要结局
Desires for Drug Questionnaire
时间窗: Days 1, 3, 5, 8, 10, 12, 42
This standardized questionnaire measures cravings for opioids. This scale includes a total of 13 items. Scoring is based on a 1-7 likert scale for each item. Specific items are assigned to one of three domains: desire, negative reinforcement, and control. A higher score indicates higher level of cravings. A lower score indicates a lesser level of opioid cravings, which is a better outcome. The primary outcome measure will be measured at various time points throughout the study to assess a change.
次要结局
未报告次要终点
研究者
Hyunhwa Lee
Assistant Professor
University of Nevada, Las Vegas