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
This trial accepts healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
3 Minute iTBS to the L DLPFC
DeviceFive daily sessions of TMS (iTBS) to the L DLPFC target.
One-Minute, Personalized, DMN Targeted CTBS
DevicePersonalized, DMN Targeted CTBS to the DMN for one minute, five daily sessions.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Precision Brain Stimulation for Cannabis Users with SchizophreniaExperimental treatment 2 interventions
Group B: Precision Brain Stimulation for Cannabis Users with Healthy ControlsActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Clinical Efficacy: Determine if rTMS affects cue-induced craving and if craving change correlates with change in functional connectivity (n=100).
Cue-induced craving will be measured using a 0-10 Visual Analog Scale (VAS) before, during, and after in-scanner presentation of visual cannabis cues. Whole DMN and L DLPFC-left insula connectivity will be calculated.
Time frame
Up to 12 weeksSecondary outcomes
1
2. Resting-state functional connectivity
The investigators will evaluate the effect of DMN-targeted cTBS on functional connectivity of the left parietal node of the DMN and the entire default mode network. The investigators will also evaluate the effect of L DLPFC-targeted iTBS on functional connectivity of the L DLPFC.
Time frame
Up to 12 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov