Applying Neuromodulation to Boost the Efficacy of Motivational Interviewing
2 other identifiers
interventional
82
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2026
CompletedFirst Submitted
Initial submission to the registry
August 13, 2026
CompletedFirst Posted
Study publicly available on registry
August 26, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
August 27, 2026
August 1, 2026
2 years
August 13, 2026
August 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Client speech
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
Timeline follow-back (TLFB) measure
30 days
MEG
Beta-band activity assessed using MNE-python
Baseline
Secondary Outcomes (1)
Cannabis use
30 days
Study Arms (2)
MI+stim
EXPERIMENTAL30 minutes of motivational interviewing (MI) with active transcranial alternating current stimulation (tACS)
MI+sham
PLACEBO COMPARATOR30 minutes of motivational interviewing (MI) with sham transcranial alternating current stimulation (tACS)
Interventions
Active transcranial alternating current stimulation
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.
Eligibility Criteria
You may qualify if:
- self-identification as having problematic cannabis use
- age 21-65 years
- SCID-5-RV module E indicating current cannabis use disorder
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Mind Research Networklead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
The Mind Research Network
Albuquerque, New Mexico, 87106, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2026
First Posted
August 26, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
August 27, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
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.