Study of Cannabidiol and Neuroimaging on Stress
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-25
SponsorIcahn School of Medicine at Mount Sinai
About this trial
Dysregulation in stress responsivity is a growing psychiatry-transdiagnostic fundamental phenomenon, with limited therapeutic strategies. With the legalization of medical and recreational cannabis, many people consume cannabidiol (CBD; a nonintoxicating cannabinoid) to alleviate stress response, without the benefit of scientific guidance. To address this gap, the investigators propose a rigorous translational neuroscience study in a clinical high-risk population to define the roles of CBD in stress response with mechanisms of mesocorticolimbic-network function and hierarchy, neurometabolic, endocrine, and behavior, building upon convergent evidence from animal models and human evidence from our laboratories.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ability to understand and give informed consent.
Individuals between 18 and 25 years old; Sex is used a biological factor (50% of individuals recruited will be females, allowing sex comparisons).
English speakers.
Cognitive performance at threshold of greater than or equal to 23 as assessed by the Montreal Cognitive Assessment (MoCA).
Disqualifiers
Have a medical condition that would make study participation unsafe, and/or which would make treatment compliance difficult, and/or would prevent adherence to study procedure. This includes but is not limited to the following criteria: history of cardiac disease, arrhythmias, neurological disease of central origin, head trauma, and seizures.
Meet criteria for any current psychiatric diagnosis as per DSM-5 [determined with the Mini International Neuropsychiatric Interview for DSM-5 (M.I.N.I. version 7.2)].
Using any psychoactive drug (other than nicotine and/or alcohol) in the past seven days (determined by lack of acute withdrawal symptoms, the negative result of a urine drug screen, timeline follow back, and alcohol breathalyzer to detect alcohol intoxication).
Positive urine drug screen (tetrahydrocannabinol, cocaine, opiates, benzodiazepines, barbiturates, amphetamines, morphine, methadone, methamphetamines, oxycodone, phencyclidine, tricyclic antidepressant, buprenorphine, methylenedioxymethamphetamine)
Trial design
Design model
Parallel
Treatments tested in this trial
Cannabidiol
Drug400mg cannabidiol
Placebo
DrugInactive oral solution
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Cannabidiol (CBD)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Neural (BOLD) functional response
Measurement of brain activity using the Blood Oxygenation Level Dependent (BOLD) signal Neural (BOLD) functional response to acute stress and network hierarchy in resting state functional connectivity. BOLD response will measure neural activity during stress conditions as compared to rest and control conditions
Time frame
Day 22
Neuronal viability indexed by GLX (combined glutamate/glutamine levels) and N-acetylaspartate (NAA) using 1H-MRS.
Concentration of brain chemicals (N-acetylaspartate, Glutamate/Glutamine Levels) as an indicator of brain health measured using non-invasive imaging of magnetic resonance spectroscopy.
Time frame
at day 23
Serum Cortisol level
The cortisol blood test measures the level of cortisol in the blood. Cortisol is a steroid (glucocorticoid or corticosteroid) hormone produced by the adrenal gland.
Time frame
Day 2, Day 34
Salivary Cortisol level
The cortisol saliva test measures the level of cortisol in the saliva. Cortisol is a steroid (glucocorticoid or corticosteroid) hormone produced by the adrenal gland.
Time frame
Day 2, Day 3Secondary outcomes
1
Visual analog scale for stress (VASStress)
The VASStress consists of a continuous line, usually 10 centimeters long which is converted to a score. Full scale is scored from 0-10, with higher score indicating higher level of stress.
Time frame
Day 2, Day 32
Visual analog scale for anxiety (VASAnxiety)
The VASAnxiety consists of a continuous line, usually 10 centimeters long which is converted to a score. Full scale is scored from 0-10, with higher score indicating higher level of anxiety.
Time frame
Day 2, Day 33
Adrenocorticotropic hormone (ACTH) level
The ACTH test measures the level of adrenocorticotropic hormone (ACTH) in the blood. ACTH is a hormone released from the pituitary gland at the base of the brain.
Time frame
Day 2, Day 34
Serum noradrenaline level
Serum noradrenaline assesses adrenal gland function and the body's response to stress.
Time frame
Day 2, Day 3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Icahn School of Medicine at Mount Sinai
Lead sponsor
Jazz Pharmaceuticals
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov