Study of Transcutaneous Auricular Neurostimulation as a Treatment for Substance Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar)
研究概览
简要总结
The study will involve a 5-day tAN treatment to attenuate alcohol withdrawal syndrome (AWS) and alter resting state functional connectivity (RSFC) between OFC and striatum in patients with alcohol use disorder (AUD). Enrolled participants will wear the tAN device on-site (at The Menninger Clinic) for the 5-day detox treatment period. Participants with AUD will be single-blinded randomized into 2 groups - a treatment group (active tAN) and a placebo group (sham tAN). Each group will consist of five separate time points - admission, screening, baseline, tAN treatment, and post tAN treatment. Clinical measures collected before, during, and after treatment will include alcohol withdrawal severity, craving, benzodiazepine usage, and assessments of depression and suicidal behaviors. Participants will undergo MRI scans before and after the treatment period to assess changes in brain connectivity and their relationship to clinical outcomes.
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
- •Male or female (evenly recruited) aged 18-64 years old
- •Meeting DSM-5 criteria of moderate or above AUD at screening using the structured clinical interview for DSM-5 (SCID-5)
- •Demonstration of at least moderate risk of alcohol use at screening using the WHO-ASSIST
- •Demonstration of high risk for moderate to severe alcohol withdrawal syndrome (Prediction of Alcohol Withdrawal Severity Scale [PAWSS] > 4 at admission)
- •Demonstration of severe withdrawal symptoms (Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised [CIWA-Ar] ≥ 8 at screening)
- •Positive urine test for alcohol at screening
- •Be able to provide written informed consent
- •Female subjects must be non-nursing and not pregnant
- •Meet the MRI safety screening form provided by the Center for Advanced MR Imaging (CAMRI) at BCM.
排除标准
- •In the opinion of the clinician and the research team at admission, be expected to fail to complete the study protocol due to probably relocation from The Menninger Clinic area or not tolerable to receive tAN
- •Current use of tobacco
- •Is pregnant or nursing
- •Contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.)
- •Do not meet the pre-screening MRI questions provided by the Center for Advanced MR Imaging (CAMRI) at BCM
研究组 & 干预措施
Active tAN
Participants will have the device applied on-site (at the Menninger Clinic) and will be required to wear the device for a minimum of 4 hours of stimulation per day. Study assessments will be collected at the time of, prior to, and at the conclusion of each tAN treatment session. Active tAN stimulation will be administered in addition to the participant's standard of care treatment.
干预措施: Sparrow Ascent (Device)
Sham tAN
Participants will have the device applied on-site (at the Menninger Clinic) and will be required to wear the device for a minimum of 4 hours of stimulation per day. Study assessments will be collected at the time of, prior to, and at the conclusion of each sham tAN treatment session. Sham tAN stimulation will be administered in addition to the participant's standard of care treatment.
干预措施: Sparrow Ascent (Sham) (Device)
结局指标
主要结局
Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar)
时间窗: Every 4 hours during the tAN treatment (Days 2-6)
The CIWA-Ar is a validated, clinician-administered scale used to assess the severity of alcohol withdrawal symptoms. The tool rates ten symptom domains-including nausea, tremor, anxiety, agitation, sweating, sensory disturbances, and orientation-to generate a total score that reflects withdrawal severity and guides clinical management. Higher scores indicate more severe withdrawal.
Average benzodiazepine use
时间窗: Every 4 hours during the tAN treatment (Days 2-6)
Benzodiazepines are commonly used to manage symptoms of alcohol withdrawal and are administered as needed based on clinical severity. Tracking benzodiazepine usage provides an indirect measure of withdrawal intensity, as higher medication requirements typically reflect more severe withdrawal symptoms, while lower usage indicates milder withdrawal.
次要结局
- Penn Alcohol Craving Scale (PACS)(Before Day 2 and after tAN treatment on Day 6)
- Montgomery-Asberg Depression Scale (MADRS)(Before Day 2 and after tAN treatment on Day 6)
- Suicidal Behaviors Questionnaire-Revised (SBQ-R)(Before Day 2 and after tAN treatment on Day 6)