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Applying Neuromodulation to Boost the Efficacy of Motivational Interviewing

2026年8月25日 更新者:The Mind Research Network

The goal of this clinical trial is to learn how adding brain stimulation to a brief counseling session affects adults with cannabis use disorder. The counseling session uses motivational interviewing, which helps people talk through their reasons for changing or not changing cannabis use. The brain stimulation is called transcranial alternating current stimulation (tACS). tACS uses electrodes on the scalp to give a very weak electrical current for a short time.

The main questions it aims to answer are:

  • Does active tACS affect what participants say during the counseling session?
  • Does active tACS change brain activity after the session?
  • Is active tACS related to less cannabis use during the month after the session?

Researchers will compare motivational interviewing with active tACS to motivational interviewing with placebo stimulation. Placebo stimulation uses the same setup but does not provide the active 30-minute stimulation. Participants will be assigned by chance to one of these groups, and neither participants nor the study staff member running the session will know which type of stimulation is used.

Participants will complete questionnaires, breath and urine tests, a recorded counseling session during active or placebo stimulation, MEG and MRI brain scans, daily text-message check-ins about cannabis use, and follow-up questionnaires about one month later.

研究概览

详细说明

Motivational interviewing is a widely used counseling approach for substance use disorders, including cannabis use disorder. A central proposed mechanism of motivational interviewing is that clients resolve ambivalence by hearing themselves express reasons for change and reasons for maintaining current behavior. Prior empirical and meta-analytic research has linked these within-session speech patterns with subsequent substance use outcomes.

This proof-of-concept randomized, double-blind, sham-controlled trial tests whether transcranial alternating current stimulation (tACS) can modulate this mechanism during a motivational interviewing session for adults with cannabis use disorder. tACS is a noninvasive form of brain stimulation that delivers weak sinusoidal electrical current through scalp electrodes. In this study, stimulation is designed to target beta-band activity in left inferior temporal cortex, a region and frequency range implicated in speech acts and commitment-related language. Pilot work suggests that beta-band activity may be stronger during statements favoring behavior change than during statements favoring continued substance use, and that tACS during motivational interviewing is feasible.

Participants are assigned to motivational interviewing with active tACS or motivational interviewing with sham stimulation. Both groups receive a single motivational interviewing session focused on cannabis-use ambivalence while the stimulation device and scalp electrodes are in place. The active condition includes approximately 30 minutes of 20-Hz beta-frequency stimulation focused on left inferior temporal cortex at 2.0 mA total combined current across electrodes. The sham condition uses the same setup with brief ramping procedures to emulate the sensations of active stimulation but without active stimulation during the intervention period.

The study evaluates whether active tACS, compared with sham stimulation, affects client speech during the motivational interviewing session, post-session brain activity, and cannabis use during the month after the session. Session audio is analyzed to quantify speech that favors change and speech that favors continued cannabis use. Neuroimaging measures include magnetoencephalography (MEG) and magnetic resonance imaging (MRI) after the intervention session. Post-stimulation resting MEG is co-registered to structural MRI to estimate, with particular interest in beta-band activity in left temporal cortex in MEG. Near-term cannabis use is assessed with daily self-report check-ins and a follow-up assessment approximately one month after baseline.

The trial is intended to provide mechanistic evidence about whether noninvasive neuromodulation can alter a candidate process of behavior change during psychotherapy. The study is not designed to provide ongoing substance use disorder treatment, but to test whether pairing tACS with a brief motivational interviewing session changes speech, brain activity, and short-term cannabis-use outcomes relative to a sham-stimulation comparison.

研究类型

介入性

注册 (估计的)

82

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Research Coordinator
  • 电话号码:505-226-2323
  • 邮箱:enact@mrn.org

学习地点

    • New Mexico
      • Albuquerque、New Mexico、美国、87106
        • The Mind Research Network

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • self-identification as having problematic cannabis use
  • age 21-65 years
  • SCID-5-RV module E indicating current cannabis use disorder

Exclusion Criteria:

  • currently engaged in treatment for any substance use disorder (SUD)
  • receiving treatment for any SUD within the prior 30 days
  • history of brain injury or major neurological diagnosis, vascular/neurodegenerative disorder, or complex primary headache disorder
  • evidence of current psychosis
  • past-year substance use disorder other than cannabis, alcohol, or nicotine
  • positive urine drug screen for any illicit drug other than cannabis
  • current or recent (past-month) medically significant withdrawal
  • MRI/tACS contraindications, including pregnancy
  • impaired hearing (psychotherapy using American Sign Language is not possible within the scope of this study)
  • insufficient corrected visual acuity to complete the assessment instruments
  • unable to read/speak English fluently
  • unable to provide valid informed consent

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:MI+stim
30 minutes of motivational interviewing (MI) with active transcranial alternating current stimulation (tACS)
Active transcranial alternating current stimulation
其他名称:
  • tacs
30 minute motivational interviewing session
安慰剂比较:MI+sham
30 minutes of motivational interviewing (MI) with sham transcranial alternating current stimulation (tACS)
sham transcranial alternating current stimulation including 30 seconds of ramp-up and ramp-down at the beginning and end of the session, with no stimulation between ramping procedures.
其他名称:
  • 假
  • tacs
30 minute motivational interviewing session

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Client speech
大体时间:Baseline
Motivational Interviewing Skill Code-defined change talk (CT; higher scores are better) and sustain talk (ST; lower scores are better) assessed via CASAA Application for Coding Treatment Interactions and session audio recording.
Baseline
Cannabis use
大体时间:30 days
Timeline follow-back (TLFB) measure
30 days
MEG
大体时间:Baseline
Beta-band activity assessed using MNE-python
Baseline

次要结果测量

结果测量
措施说明
大体时间
Cannabis use
大体时间:30 days
Urine drug screen (UDS) measure
30 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2028年8月1日

研究完成 (估计的)

2028年8月1日

研究注册日期

首次提交

2026年8月13日

首先提交符合 QC 标准的

2026年8月21日

首次发布 (实际的)

2026年8月26日

研究记录更新

最后更新发布 (实际的)

2026年8月27日

上次提交的符合 QC 标准的更新

2026年8月25日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

There be maximum appropriate sharing of scientific data underlying peer-reviewed publications and other findings resulting from the work supported by this award (including preprints, refereed papers reported at conferences, and other findings). The scientific data underlying peer-reviewed publications will be shared by the time of publication, or for other findings, by the end of the period of performance, which includes no-cost extensions. Data from participants who have opted not to share their data will not be shared or uploaded. All data sharing is contingent on review and approval by the supervising IRB. All structural MRIs will be de-faced before sharing or uploading into the repository, and the participant's head/face shape collected during MEG preparation will be removed before uploading/sharing. Instead, the MEG-MRI transformation matrix will be uploaded and shared. Neither audio recordings nor data derived from audio recordings will be shared or uploaded.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

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