Pilot Investigation of at Home Caloric Vestibular Neuromodulation for Use in Substance Use Disorders
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- ODAS score measuring craving severity
研究概览
简要总结
The purpose of this study is to determine efficacy and effect of CVS (caloric vestibular stimulation)
详细描述
This study is designed as a nonrandomized, single-blind, sham-controlled trail in which willing participants will receive a 5 day course of twice daily caloric vestibular stimulation (CVS) or sham treatment. CVS involves twice daily sessions of CVS each lasting 15 minutes. The week before the intervention baseline characterization of mood and substance craving will be conducted using standard mood and substance use questionnaires. Prior to treatment beginning participants will undergo structural and functional MR imaging. Participants will also undergo a standard battery of questionnaires, including cognitive testing, mood and affect surveys, and surveys specific to SUD. During each of the 5 treatment days the participants will be asked to fill out questionnaires related to mood and craving symptoms. Participants will be blinded to sham stimulation or the standard CVS protocol. At the end of the 5 day course participants will be scanned again in MRI and asked to fill out the same battery of questions. Consistent with the existing standard of care participants will also receive two urine drug screens (UDS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will not know if they are receiving therapeutic CVS or sham stimulation.
Participant survey responses will be blinded during analysis and only the use of non-informative catalogue will be used. This will eliminate bias in the analysis of the survey data.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will have a diagnosed SUD (including but not limited to Opiate, Alcohol, Cocaine, Nicotine, or Amphetamine Use Disorders).
- •Subjects will be between the age of 17 and 50 years old
- •Subjects will have been abstinent on a stable treatment regimen for at least 4 weeks
- •Subjects will be able to sit still for MRI imaging
- •Subjects will be able to read and complete survey questionnaires
- •Subjects will reliably be abstinent from their drug of choice through the 5 day intervention as determined by the discretion of a clinician
排除标准
- •Subjects will be excluded for comorbid neuropathology (eg history of stroke or TBI)
- •Subjects will be excluded if they are at high risk for relapse as determined by a clinician
- •Subjects will be excluded if they are unable to tolerate the CVS devise
- •Subjects will be excluded if they have malformations of or existing trauma to the external auditory canal
结局指标
主要结局
ODAS score measuring craving severity
时间窗: 3 months
Measured items 5a and 5b of the ODAS (Opiate Dosage Adequacy Scale) that deal with craving and craving severity directly. It is scored by Likert-type scores ranging from 1 to 5. The higher the score the higher the craving severity A reduction in craving and craving severity will be the primary outcome. This single dimension is important for risk of relapse, but does not by itself represent treatment adequacy as a whole.
ODAS score measuring adequacy of treatment
时间窗: 3 months
Measured by ODAS (Opiate Dosage Adequacy Scale).The ODAS clinical interview includes 10 items that evaluate six components of the construct "dose adequacy." Questions on the ODAS that measure symptom frequency are coded with Likert-type scores ranging from 1 to 5. Questions that measure symptom severity are coded on a visual analogue scale (VAS) using the same score range. The dimensional model provides a total score derived from a weighted sum of the scores of the individual items. The higher the total score, the more "adequate" the dose is considered to be. An increase in the total ODAS dimensional model score will indicate improved adequacy of treatment. This adequacy includes craving, but also represents multiple dimensions relevant to the treatment of OUD. An improvement of adequacy, irrespective of craving, is indicative of an effective treatment, and would indicate an effect of treatment on a feature of OUD other than craving.
次要结局
- PHQ-9 scores measuring Depressive Symptoms(3 months)
- GAD-7 scores measuring anxiety(3 months)