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Applying Neuromodulation to Boost the Efficacy of Motivational Interviewing

25 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

82

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Research Coordinator
  • Numero di telefono: 505-226-2323
  • Email: enact@mrn.org

Luoghi di studio

    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti, 87106
        • The Mind Research Network

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: MI+stim
30 minutes of motivational interviewing (MI) with active transcranial alternating current stimulation (tACS)
Active transcranial alternating current stimulation
Altri nomi:
  • tacs
30 minute motivational interviewing session
Comparatore 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.
Altri nomi:
  • finto
  • tacs
30 minute motivational interviewing session

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Client speech
Lasso di tempo: 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
Lasso di tempo: 30 days
Timeline follow-back (TLFB) measure
30 days
MEG
Lasso di tempo: Baseline
Beta-band activity assessed using MNE-python
Baseline

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cannabis use
Lasso di tempo: 30 days
Urine drug screen (UDS) measure
30 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 agosto 2028

Completamento dello studio (Stimato)

1 agosto 2028

Date di iscrizione allo studio

Primo inviato

13 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 agosto 2026

Primo Inserito (Effettivo)

26 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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