Cannabis Use Disorder, SevereCAPENCT06907979
Cannabis and Processing Emotions Study
A study testing TMS - Active iTBS and TMS - Active cTBS in people with Cannabis Use Disorder, Severe, run by Auburn University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cannabis Use Disorder, Severe
- What is being tested?
- TMS - Active iTBS and TMS - Active cTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Auburn University Neuroimaging Center
Auburn, Alabama, 36849
Brandon Schermitzler, M.S., 334-844-6642, scampi@auburn.edu
About this study
Official title: Experimental Manipulation of the Emotional Salience of Cannabis Use-Related Information in Regular Cannabis Users
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?
Read more
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
- Being tested
- TMS - Sham, TMS - Active iTBS, TMS - Active cTBS
- Keywords
- cannabis, cannabis use disorder, emotional salience, problem recognition, problem awareness, transcranial magnetic stimulation, theta burst stimulation, TMS, TBS, medial orbitofrontal cortex, mOFC
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMS - ShamDevice
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 iTBSDevice
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 cTBSDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| Sham Theta Burst Stimulation (TBS) | Sham comparator | Not described Receives: Device: TMS - Sham |
| Intermittent Theta Burst Stimulation (iTBS) | Experimental | Not described Receives: Device: TMS - Active iTBS |
| Continuous Theta Burst Stimulation (cTBS) | Experimental | Not described Receives: Device: TMS - Active cTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow (CBF) in the medial orbitofrontal cortex
Function magnetic resonance imaging (fMRI) will be used to measure cerebral blood flow (CBF) in the medial orbitofrontal cortex (mOFC) using a 3-Tesla magnet. CBF values will be compared within-subject across stimulation conditions.
Measured: Lab Visits 2 (day 8), 3 (day 15), and 4 (day 22)
Amplitude of neurophysiological responses to self-referential cannabis use-related information
Electroencephalogram (EEG) will be used to measure late positive potential (LPP) amplitudes to personalized auditory statements about cannabis-related positive expectancies and negative consequences, along with neutral stimuli. LPP amplitudes will be compared within-subject across stimulation conditions.
Measured: Lab Visits 2 (day 8), 3 (day 15), and 4 (day 22)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start22 Jan 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use Disorder, SevereStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Addiction Psychology, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Samantha Fede, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907979
- Sponsor's protocol ID
- STUDY00000423
- Acronym
- CAPE
- Status last verified
- May 2026
- First submitted
- 19 Mar 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Manipulation of the Emotional Salience of Cannabis Use-Related Information in Regular Cannabis Users
- ClinicalTrials.gov ID
- NCT06907979
- Acronym / sponsor ID
- CAPE / STUDY00000423
- Conditions
- Cannabis Use Disorder, Severe
- Keywords
- cannabis, cannabis use disorder, emotional salience, problem recognition, problem awareness, transcranial magnetic stimulation, theta burst stimulation, TMS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Collaborators
- Society of Addiction Psychology, National Institute on Drug Abuse (NIDA)
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham Theta Burst Stimulation (TBS) | Sham comparator | Device: TMS - Sham |
| Intermittent Theta Burst Stimulation (iTBS) | Experimental | Device: TMS - Active iTBS |
| Continuous Theta Burst Stimulation (cTBS) | Experimental | Device: TMS - Active cTBS |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMS - ShamFor 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. | Device | Sham Theta Burst Stimulation (TBS) |
| TMS - Active iTBSTrains 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) | Device | Intermittent Theta Burst Stimulation (iTBS) |
| TMS - Active cTBSTrains 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) | Device | Continuous Theta Burst Stimulation (cTBS) |
Primary outcome
Cerebral blood flow (CBF) in the medial orbitofrontal cortex
Time frame: Lab Visits 2 (day 8), 3 (day 15), and 4 (day 22)
Function magnetic resonance imaging (fMRI) will be used to measure cerebral blood flow (CBF) in the medial orbitofrontal cortex (mOFC) using a 3-Tesla magnet. CBF values will be compared within-subject across stimulation conditions.
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)
Electroencephalogram (EEG) will be used to measure late positive potential (LPP) amplitudes to personalized auditory statements about cannabis-related positive expectancies and negative consequences, along with neutral stimuli. LPP amplitudes will be compared within-subject across stimulation conditions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS - Active iTBS and TMS - Active cTBS in people with Cannabis Use Disorder, Severe, run by Auburn University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brandon Schermitzler, M.S. (334-844-6642, bzs0103@auburn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.