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- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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 de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Research Coordinator
- Número de telefone: 505-226-2323
- E-mail: enact@mrn.org
Locais de estudo
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87106
- The Mind Research Network
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: MI+stim
30 minutes of motivational interviewing (MI) with active transcranial alternating current stimulation (tACS)
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Active transcranial alternating current stimulation
Outros nomes:
30 minute motivational interviewing session
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|
Comparador de Placebo: MI+sham
30 minutes of motivational interviewing (MI) with sham transcranial alternating current stimulation (tACS)
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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.
Outros nomes:
30 minute motivational interviewing session
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Client speech
Prazo: Baseline
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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.
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Baseline
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Cannabis use
Prazo: 30 days
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Timeline follow-back (TLFB) measure
|
30 days
|
|
MEG
Prazo: Baseline
|
Beta-band activity assessed using MNE-python
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Baseline
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Cannabis use
Prazo: 30 days
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Urine drug screen (UDS) measure
|
30 days
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Terapêutica
- Serviços de Saúde
- Instalações de saúde Força e serviços de trabalho
- Disciplinas e atividades comportamentais
- Aconselhamento diretivo
- Aconselhamento
- Serviços de Saúde Mental
- Terapia de estimulação elétrica
- Terapia convulsiva
- Terapias somáticas psiquiátricas
- ElectroShock
- Técnicas psicológicas
- Entrevista motivacional
- Estimulação de corrente direta transcraniana
Outros números de identificação do estudo
- 20-156
- 1UG3DA061594 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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