一项随机、假对照临床试验，旨在评估NET Device™在减轻阿片类药物停用期间戒断症状严重程度方面的效果。

A randomized, sham-controlled clinical trial to evaluate the NET Device™ for reducing withdrawal symptom severity during opioid discontinuation.

作者信息

Greenwald Mark K, Arfken Cynthia L, Winston Joe R

机构信息

Department of Psychiatry and Behavioral Neurosciences, Wayne State University School of Medicine, Detroit, MI, United States.

NET Recovery Corp™ (NRC), Wilmington, DE, United States.

出版信息

Front Psychiatry. 2025 Feb 19;16:1510428. doi: 10.3389/fpsyt.2025.1510428. eCollection 2025.

BACKGROUND

Neuromodulation is a promising approach for opioid discontinuation, as not all patients with opioid use disorder (OUD) seek pharmacotherapy. The NET Device is a non-invasive, battery-powered, portable, device that provides bilateral, transcranial, transcutaneous, alternating current stimulation (tACS) for patients experiencing opioid withdrawal. This clinical trial prospectively evaluated whether NET Device utilization is effective for persons with OUD undergoing opioid discontinuation without medications for OUD (MOUD).

METHODS

This randomized, sham-controlled trial was conducted at a single residential treatment center. Persons with OUD undergoing opioid discontinuation were assigned to active or sham device treatment. Clinical Opiate Withdrawal Scale (COWS) total scores were measured prior to and during device use. We tested whether active stimulation would produce a clinically meaningful (≥15%) decrease in COWS score from baseline to 1-hr post-stimulation, compared to sham.

RESULTS

108 participants (55 sham, 53 active; 59.3% male, 89.8% white; 71.3% fentanyl-positive) form the intent-to-treat dataset. Mean ( ± 1 SD) COWS score in the active device group decreased from baseline (18.1 + 4.4) to 1-hr (7.0 + 4.1); this 61.3% decrease (=2.14) exceeded the pre-specified 15% criterion. COWS scores decreased more for active (-11.1 ± 5.2) than sham (-8.8 ± 6.3), <.05, =-.41. A higher proportion of participants in active . sham showed ≥15% reduction in COWS (98.1% . 83.6%), =.016. Device utilization was longer for active than sham, 43.9 + 46.2 . 30.0 + 39.2 hours, =.008, and fewer participants requested MOUD (26% . 49%, p<0.02).

CONCLUSION

The NET Device is effective, safe and well-tolerated for reducing opioid withdrawal symptoms. This device received FDA market clearance in May 2024.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, identifier NCT04916600.

背景

神经调节是一种有前景的阿片类药物戒断方法，因为并非所有阿片类药物使用障碍（OUD）患者都寻求药物治疗。NET设备是一种无创、电池供电、便携式设备，可为经历阿片类药物戒断的患者提供双侧、经颅、经皮交流电刺激（tACS）。这项临床试验前瞻性评估了NET设备的使用对于正在停用阿片类药物且未接受阿片类药物使用障碍药物治疗（MOUD）的OUD患者是否有效。

方法

这项随机、假对照试验在一个单一的住院治疗中心进行。正在停用阿片类药物的OUD患者被分配到活性设备组或假设备组进行治疗。在设备使用前和使用期间测量临床阿片类药物戒断量表（COWS）总分。我们测试了与假刺激相比，活性刺激是否会使COWS评分从基线到刺激后1小时产生具有临床意义的（≥15%）下降。

结果

108名参与者（55名假刺激组，53名活性刺激组；59.3%为男性，89.8%为白人；71.3%为芬太尼阳性）构成意向性分析数据集。活性设备组的平均（±1标准差）COWS评分从基线时的（(18.1 + 4.4)）降至1小时时的（(7.0 + 4.1)）；这种61.3%的下降（=(2.14)）超过了预先设定的15%的标准。活性刺激组的COWS评分下降幅度（(-11.1 ± 5.2)）大于假刺激组（(-8.8 ± 6.3)），(p<.05)，(d =-.41)。活性刺激组中COWS评分降低≥15%的参与者比例高于假刺激组（98.1% 对 83.6%），(p =.016)。活性刺激组的设备使用时间比假刺激组长，分别为(43.9 + 46.2)小时和(30.0 + 39.2)小时，(p =.008)，且要求进行MOUD的参与者较少（26% 对 49%，(p<0.02)）。