Cannabis and Processing Emotions Study

ConditionCannabis Use Disorder, Severe

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-50

SponsorAuburn University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

TMS - Sham
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.
TMS - Active iTBS
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)
TMS - Active cTBS
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)

Treatment groups

24 Participants

are divided into 3 treatment groups

Group A: Sham Theta Burst Stimulation (TBS)Sham comparator 1 intervention

Group B: Intermittent Theta Burst Stimulation (iTBS)Experimental treatment 1 intervention

Group C: Continuous Theta Burst Stimulation (cTBS)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

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

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.

Time frame

Lab Visits 2 (day 8), 3 (day 15), and 4 (day 22)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Auburn University

Lead sponsor

Society of Addiction Psychology

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

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