- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Research Coordinator
- Telefonní číslo: 505-226-2323
- E-mail: enact@mrn.org
Studijní místa
-
-
New Mexico
-
Albuquerque, New Mexico, Spojené státy, 87106
- The Mind Research Network
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: MI+stim
30 minutes of motivational interviewing (MI) with active transcranial alternating current stimulation (tACS)
|
Active transcranial alternating current stimulation
Ostatní jména:
30 minute motivational interviewing session
|
|
Komparátor placeba: 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.
Ostatní jména:
30 minute motivational interviewing session
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Client speech
Časové okno: 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
Časové okno: 30 days
|
Timeline follow-back (TLFB) measure
|
30 days
|
|
MEG
Časové okno: Baseline
|
Beta-band activity assessed using MNE-python
|
Baseline
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Cannabis use
Časové okno: 30 days
|
Urine drug screen (UDS) measure
|
30 days
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Terapeutika
- Zdravotní služby
- Zdravotnická zařízení pracovní síla a služby
- Disciplíny a činnosti chování
- Poradenství směrnice
- Poradenství
- Služby duševního zdraví
- Elektrická stimulační terapie
- Kvisulská terapie
- Psychiatrické somatické terapie
- Electroshock
- Psychologické techniky
- Motivační pohovory
- Transkraniální stimulace přímého proudu
Další identifikační čísla studie
- 20-156
- 1UG3DA061594 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .