Cannabis and Processing Emotions Study

NCT ID: NCT06907979

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-05-31

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

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Sham Theta Burst Stimulation (TBS)

Group Type: SHAM_COMPARATOR

TMS - Sham

Intervention Type: DEVICE

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.

Intermittent Theta Burst Stimulation (iTBS)

Group Type: EXPERIMENTAL

TMS - Active iTBS

Intervention Type: DEVICE

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)

Continuous Theta Burst Stimulation (cTBS)

Group Type: EXPERIMENTAL

TMS - Active cTBS

Intervention Type: DEVICE

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)

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.

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: DEVICE

Eligibility 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

• 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Society of Addiction Psychology

UNKNOWN

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Auburn University

OTHER

Sponsor Role: lead

Responsible Party

Samantha Fede

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Brandon Schermitzler, M.S.

Role: CONTACT

Phone: 334-844-6642

Email: bzs0103@auburn.edu

Other Identifiers

STUDY00000423

Identifier Type: -

Identifier Source: org_study_id