Recruiting

TMS, TBS, EEG

Sponsor:

Auburn University

Code:

NCT06907979

Conditions

Cannabis Use Disorder, Severe

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

TMS - Sham

TMS - Active iTBS

TMS - Active cTBS

Study Details

Brief summary:

The goal of this study is to test a causal neural mechanism of cannabis use-related problem recognition in individuals with severe cannabis use disorder using a non-invasive form of neuromodulation called transcranial magnetic stimulation (TMS). The main question it aims to answer is:

-Does manipulating neural activity in the medial orbitofrontal cortex of the brain affect cannabis use-related problem recognition?

Researchers will compare three forms of theta burst stimulation (TBS; sham, intermittent, and continuous) in each participant to see if manipulations in neural activity lead to changes in cannabis use-related problem recognition.

Participants will complete a screening interview about their mental health and substance use history and complete four in-person laboratory sessions, which involve questionnaires, four brief magnetic resonance imaging (MRI) scans, three TBS sessions, and three electroencephalogram (EEG) sessions. Participants will also be asked to provide urine samples and take saliva and/or breathalyzer tests at some of the lab visits.

Conditions

Cannabis Use Disorder, Severe

Study ID

NCT06907979

Start date

Jan 22, 2026

Status verified date

May, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

sham comparator: Sham Theta Burst Stimulation (TBS)

experimental: Intermittent Theta Burst Stimulation (iTBS)

experimental: Continuous Theta Burst Stimulation (cTBS)

Interventions

TMS - Sham

For sham TMS, participants will receive a placebo version of either cTBS or iTBS (in a counterbalanced order). To do this, we will use the "placebo" side of the TMS coil, which produces the same sound volume and sequence as active TMS but does not induce neuromodulatory effects due to using the opposite side of the TMS coil as the "active" side TMS coil. To simulate somatosensory effects of active TMS, sham TMS also use superficial stimulation with the same pulse sequence via a small electrode placed on the target region underneath the coil.

TMS - Active iTBS

Trains consisting of bursts of three stimuli at 50 Hz repeated at 5 Hz frequency delivered at 110% of measured individual motor threshold in 20 x 2-second trains with 8-second intertrain intervals (192 seconds total)

TMS - Active cTBS

Trains consisting of bursts of three stimuli at 50 Hz repeated at 5 Hz frequency delivered at 110% of measured individual motor threshold in 1 x 40-second train (40 seconds total)

Primary outcome measure

  • Cerebral blood flow (CBF) in the medial orbitofrontal cortex [ Time Frame: Lab Visits 2 (day 8), 3 (day 15), and 4 (day 22) ]
  • Amplitude of neurophysiological responses to self-referential cannabis use-related information [ Time Frame: Lab Visits 2 (day 8), 3 (day 15), and 4 (day 22) ]

Central Contacts and Locations

Central contacts

Brandon Schermitzler, M.S.

334-844-6642bzs0103@auburn.edu

Locations

Auburn University Neuroimaging Center

Recruiting

Auburn, Alabama, United States, 36849

Contacts

Brandon Schermitzler, M.S.

334-844-6642scampi@auburn.edu

More Information

Sponsor

Auburn University

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • cannabis
  • cannabis use disorder
  • emotional salience
  • problem recognition
  • problem awareness
  • transcranial magnetic stimulation
  • theta burst stimulation
  • TMS
  • TBS
  • medial orbitofrontal cortex
  • mOFC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by Auburn University on 2026-05-06.