Magnetic brain stimulation to change how people with severe cannabis use disorder recognize cannabis-related problems
Experimental Manipulation of the Emotional Salience of Cannabis Use-Related Information in Regular Cannabis Users
This project will try short bursts of magnetic brain stimulation to see if changing activity in a brain area called the medial orbitofrontal cortex changes how people with severe cannabis use disorder notice problems from their cannabis use.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Auburn University Academic / other |
| Locations | 1 site (Auburn, Alabama) |
| Trial ID | NCT06907979 on ClinicalTrials.gov |
What this trial studies
The study tests whether manipulating activity in the medial orbitofrontal cortex with three forms of theta burst stimulation (sham, intermittent, continuous) changes cannabis use–related problem recognition. Each participant will receive all three stimulation conditions across four in-person laboratory sessions that include questionnaires, four brief MRI scans, three TBS sessions, and three EEG sessions, plus urine testing. Eligible participants must have current severe Cannabis Use Disorder, frequent recent cannabis use, a THC-positive urine sample, and report multiple cannabis-related problems, while people with frequent non-cannabis illicit drug use or moderate/severe alcohol use disorder are excluded. Behavioral measures of problem recognition will be compared after each stimulation condition to test whether altering OFC activity produces measurable changes in problem awareness.
Who should consider this trial
Good fit: Adults with current severe Cannabis Use Disorder who use cannabis at least four days per week (roughly 20+ days per month), provide a THC-positive urine sample, can read and write English, and endorse multiple cannabis-related problems are the intended participants.
Not a fit: People with infrequent or mild cannabis use, regular non-cannabis illicit drug use, moderate to severe alcohol use disorder, or those unable to attend in-person MRI/TBS visits are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could increase problem awareness in people with severe cannabis use disorder and thereby encourage earlier help-seeking or more targeted treatment.
How similar studies have performed: While some TMS approaches have shown promise for substance use outcomes in small trials, targeting the medial orbitofrontal cortex with theta-burst stimulation specifically to change problem recognition is relatively novel and not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Meets criteria for current, severe Cannabis Use Disorder (CUD), as assessed by the Structured Clinical Interview (SCID) for the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) during the screening interview * Reports engagement in cannabis use at least four days per week, on average, over the past year * Provide a urine sample positive for tetrahydrocannabinol (THC) * Able to read and write in English * Has used cannabis at least 20 days in the past month * Endorses at least 10 distinct (of 40 possible) cannabis use-related problems across the screening interview and Lab Visit 1 questionnaires Exclusion Criteria: * Other non-cannabis illicit substance use more than once per month, on average, over the past year * Current DSM-5 moderate or severe Alcohol Use Disorder, as assessed by the Structured Clinical Interview (SCID) for the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) during the screening interview * History of bipolar I or psychosis spectrum disorders, as assessed by the SCID for DSM-5 during the screening interview * Acute suicidality requiring treatment escalation, as assessed during the screening interview * Currently taking any daily psychotropic medication * Failure to meet standard MRI inclusion criteria (i.e., no presence of claustrophobia; cardiac pacemakers; neural pacemakers; surgical clips in the brain or blood vessels; surgically implanted metal plates, screws, or pins; cochlear implants; implanted uterine devices; metal braces; other metal objects in the body; history of significant injury to the brain or spinal cord; or pregnancy) * Medical contraindications for transcranial magnetic stimulation (TMS; i.e., presence of a neurological disorder known to alter risk for seizures \[e.g., stroke, aneurysm, brain surgery, structural brain lesion, brain injury, frequent/severe headaches\], current medication therapy known to alter seizure threshold \[e.g., clomipramine, Monoamine Oxidase inhibitors, imipramine, clozapine\], recurrent seizures or epilepsy or family history of hereditary epilepsy, pregnancy, metallic implants in the body or other devices that may be affected by magnetic fields, or significant heart disease or cerebrovascular disease) * History of allergies to cosmetics/lotions or EEG gel * History of migraines * Currently engaged in treatment for Cannabis Use Disorder
Where this trial is running
Auburn, Alabama
- Auburn University Neuroimaging Center — Auburn, Alabama, United States (Recruiting)
Study contacts
- Study coordinator: Brandon Schermitzler, M.S.
- Email: bzs0103@auburn.edu
- Phone: 334-844-6642
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.