Cannabis Use study: 3 Minute iTBS to the L DLPFC vs One-Minute
Official title Precision Brain Stimulation to Reduce Cannabis Craving in Schizophrenia
ClinicalTrials.gov ID: NCT07196462
What this study is testing
- What it's testing
- The study wants to know if repeated magnetic brain stimulation changes brain network activity and reduces cannabis cravings in people with schizophrenia or schizoaffective disorder.
- Who it's for
- Adults with schizophrenia or schizoaffective disorder who use cannabis, and healthy adults who use cannabis.
- What's involved
- Participants will receive two types of repetitive transcranial magnetic stimulation (rTMS) sessions, undergo brain imaging, and complete craving and cognitive tests.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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)...
- History of head trauma resulting in any loss of consciousness (\>15 minutes) or neurological sequelae
- Current history of poorly controlled headaches including chronic medication for migraine prevention
See the full eligibility criteria
- 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.
- 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.
- History of head trauma resulting in any loss of consciousness (\>15 minutes) or neurological sequelae
- Current history of poorly controlled headaches including chronic medication for migraine prevention
- History of fainting spells of unknown or undetermined etiology that might constitute seizures
- History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy with the exception of a single seizure of benign etiology (e.g.
- Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
- Any metal in the brain or skull (excluding dental fillings) or elsewhere in the body unless cleared by the responsible covering MD (e.g. MRI compatible joint replacement)
- Any devices such as pacemaker, medication pump, nerve stimulator, TENS unit, ventriculo-peritoneal shunt unless cleared by the responsible covering MD
- All female participants of child-bearing age will be required to have a pregnancy test; any participant who is pregnant or planning to become pregnant will not be enrolled in the study
- Medications will be reviewed by the responsible covering physician and a decision about inclusion will be made based on the participant's past medical history, drug dose, history of recent medication changes or duration...
- Any changes in medications or hospitalizations within the past 30 days.
- Participants who, in the investigator's opinion, might not be suitable for the study or would be unable to tolerate the study visit These exclusion criteria strictly follow all recommended guidelines as endorsed by the...
The study team makes the final eligibility decision.
Where it is enrolling
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Nashville, Tennessee, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.