Precision Brain Stimulation to Reduce Cannabis Craving in Schizophrenia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVanderbilt University Medical Center

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

DSM-5 intellectual disability

Substance use disorder (other than cannabis or nicotine) within the past three months

Positive urine drug screen for illicit substance use that can increase seizure risk (cocaine, benzodiazepines, amphetamine, methamphetamine)

Any history of a progressive or genetic neurologic disorder (e.g. Parkinson's disease, multiple sclerosis, tuberous sclerosis, Alzheimer's Disease) or acquired neurological disease (e.g. stroke, traumatic brain injury, tumor), including intracranial lesions

Trial design

Treatments tested in this trial

  • 3 Minute iTBS to the L DLPFC
  • One-Minute, Personalized, DMN Targeted CTBS

Treatment groups

100 Participants
are divided into 2 treatment groups