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Applying Neuromodulation to Boost the Efficacy of Motivational Interviewing

25 août 2026 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

82

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Research Coordinator
  • Numéro de téléphone: 505-226-2323
  • E-mail: enact@mrn.org

Lieux d'étude

    • New Mexico
      • Albuquerque, New Mexico, États-Unis, 87106
        • The Mind Research Network

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: MI+stim
30 minutes of motivational interviewing (MI) with active transcranial alternating current stimulation (tACS)
Active transcranial alternating current stimulation
Autres noms:
  • tacs
30 minute motivational interviewing session
Comparateur placebo: 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.
Autres noms:
  • faux
  • tacs
30 minute motivational interviewing session

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Client speech
Délai: 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
Délai: 30 days
Timeline follow-back (TLFB) measure
30 days
MEG
Délai: Baseline
Beta-band activity assessed using MNE-python
Baseline

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Cannabis use
Délai: 30 days
Urine drug screen (UDS) measure
30 days

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

1 août 2028

Achèvement de l'étude (Estimé)

1 août 2028

Dates d'inscription aux études

Première soumission

13 août 2026

Première soumission répondant aux critères de contrôle qualité

21 août 2026

Première publication (Réel)

26 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

27 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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