Precision Brain Stimulation to Reduce Cannabis Craving in Schizophrenia

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT07196462
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 3 Minute iTBS to the L DLPFC — DEVICE
    Five daily sessions of TMS (iTBS) to the L DLPFC target.
  • One-Minute, Personalized, DMN Targeted CTBS — DEVICE
    Personalized, DMN Targeted CTBS to the DMN for one minute, five daily sessions.

Study Details

The central hypothesis is this: Brain circuits most relevant to cannabis use in schizophrenia are distinct from pathways identified in healthy controls who use cannabis. This study seeks to provide evidence that targeted stimulation of the DMN leads to both altered network activity and a concomitant behavioral change in cue-induced craving and cognitive performance in individuals with schizophrenia and schizoaffective disorder, while targeted stimulation of the L DLPFC leads to these changes in healthy controls who use cannabis. This study will test a model that integrates brain network pathophysiology and cognition to 1) explain the prevalence of cannabis use in schizophrenia and 2) identify a target for engagement in schizophrenia. This study seeks to establish a neuroscientific framework to guide future treatment-oriented studies aimed at reducing craving and improving cognitive performance in individuals with schizophrenia and schizoaffective disorder. This is a study of the effect of 2 rTMS interventions on functional connectivity and craving in individuals with schizophrenia or schizoaffective disorder and healthy controls who use cannabis. Aim 1: Target Engagement: Determine if rTMS manipulates functional connectivity of each target (DMN, L DLPFC) (n=100). Aim 2: Clinical Efficacy: Determine if rTMS affects cue-induced craving and if craving change correlates with change in functional connectivity (n=100). As an exploratory analysis, the factors that explain individual variance in rTMS-induced connectivity change will also be explored.

Key Dates

Start date
Jan 15, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Precision Brain Stimulation for Cannabis Users with Schizophrenia
    Participants with schizophrenia who use cannabis.
  • Active Comparator: Precision Brain Stimulation for Cannabis Users with Healthy Controls
    Healthy controls who use cannabis.

Primary Outcome Measure

Clinical Efficacy: Determine if rTMS affects cue-induced craving and if craving change correlates with change in functional connectivity (n=100). [ Time Frame: Up to 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt Psychiatric HospitalNashvilleTennessee37212
Heather Ward, MD, MD
[email protected]
6154345891

Find similar trials in Nashville, TN

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Vanderbilt Psychiatric Hospital· Nashville, TN

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