Health TrialsbyHealthPanel

Applying Neuromodulation to Boost the Efficacy of Motivational Interviewing

ConditionCannabis Use Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorThe Mind Research Network

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

self-identification as having problematic cannabis use

age 21-65 years

SCID-5-RV module E indicating current cannabis use disorder

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • transcranial alternating current stimulation

    Device

    Active transcranial alternating current stimulation

  • sham transcranial alternating current stimulation

    Device

    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.

  • Motivational interviewing (MI)

    Behavioral

    30 minute motivational interviewing session

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: MI+stimExperimental treatment 2 interventions
Group B: MI+shamPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

Cannabis use

Timeline follow-back (TLFB) measure

Time frame
30 days
3

MEG

Beta-band activity assessed using MNE-python

Time frame
Baseline

Secondary outcomes

1

Cannabis use

Urine drug screen (UDS) measure

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Mind Research Network

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: