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Precision Brain Stimulation to Reduce Cannabis Craving in Schizophrenia

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• Age between 18-65 years

• Diagnosis of a psychotic disorder according to DSM-5 criteria and confirmed by SCID

• Current cannabis use of at least 2/10 on a Visual Analog Scale

• Current cannabis use (confirmed by urine cannabis testing)

• Must be able to read, speak and understand English

• Must be judged by study staff to be capable of completing the study procedures

• Participants will be in stable outpatient psychiatric treatment and psychiatrically stable with no recent (within the past 30 days) psychiatric hospitalizations or changes in their psychiatric medication regimens.

⁃ \- All of the above except for participants will not have a diagnosis of a psychotic disorder nor a first-degree relative with a psychotic disorder.

Locations
United States
Tennessee
Vanderbilt Psychiatric Hospital
RECRUITING
Nashville
Contact Information
Primary
Jillian G Connolly, B.S.
jillian.connolly@vumc.org
6154345891
Time Frame
Start Date: 2026-01-15
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Vanderbilt University Medical Center

This content was sourced from clinicaltrials.gov