Cannabis and Processing Emotions Study (CAPE)

May 5, 2026 updated by: Samantha Fede, Auburn University

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?

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Auburn, Alabama, United States, 36849
        • Recruiting
        • Auburn University Neuroimaging Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham Theta Burst Stimulation (TBS)
Device: 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.
Experimental: Intermittent Theta Burst Stimulation (iTBS)
Device: 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)
Experimental: Continuous Theta Burst Stimulation (cTBS)
Device: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
Lab Visits 2 (day 8), 3 (day 15), and 4 (day 22)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Auburn University

Collaborators

National Institute on Drug Abuse (NIDA)
Society of Addiction Psychology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

March 19, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 3, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000423

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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