- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07787572
Applying Neuromodulation to Boost the Efficacy of Motivational Interviewing
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
Stato
Condizioni
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
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Research Coordinator
- Numero di telefono: 505-226-2323
- Email: enact@mrn.org
Luoghi di studio
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87106
- The Mind Research Network
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
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
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)
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Active transcranial alternating current stimulation
Altri nomi:
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:
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
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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
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Terapie
- Servizi sanitari
- Force di lavoro e servizi per le strutture sanitarie
- Discipline e attività comportamentali
- Consulenza direttiva
- Consulenza
- Servizi di salute mentale
- Terapia di stimolazione elettrica
- Terapia convulsiva
- Terapie somatiche psichiatriche
- Elettroshock
- Tecniche psicologiche
- Intervista motivazionale
- Stimolazione transcranica di corrente continua
Altri numeri di identificazione dello studio
- 20-156
- 1UG3DA061594 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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