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
Qualifiers
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
Treatments tested in this trial
- Cannabidiol
- Placebo
Treatment groups
160 Participants
are divided into 2 treatment groupsSponsors and collaborators
Icahn School of Medicine at Mount Sinai
Lead sponsor
Jazz Pharmaceuticals
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov