Cannabidiol (CBD) and Stress Response: Psychobiological Mechanisms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-70
SponsorUniversity of Minnesota
About this trial
The aim of this study is to determine the effects of regular cannabidiol (CBD) use on the psychobiological mechanisms of the stress response. This will be achieved by comparing acute stress responses of adults who either use or do not use CBD regularly. Correlates of CBD use, including tobacco use, will be collected.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults who are relatively healthy and aged 21-70 years.
Must keep a normal sleep schedule (sleep during nighttime, awake during daytime).
Must either (1) use CBD daily/regularly or (2) not use CBD regularly.
Disqualifiers
Participated in previous acute stress studies that included a similar stress induction.
Current, unstable: major psychiatric disorder or medical condition (e.g., uncontrolled hypertension above 160/100).
Self-reported current pregnancy.
Self-reported current use of illicit substances (other than cannabis).
Trial design
Design model
Single group
Treatments tested in this trial
Stress Intervention
Other interventionExperimental Stress: Behavioral induction of acute psychosocial and physiological stress. First, participants will be provided with a speech topic and given 4 minutes to prepare a speech that they subsequently deliver in front of evaluators and a video recorder. Then, participants will complete a mental arithmetic task in front of the evaluators for 8 minutes. Then, participants will complete a cold pressor task in which they submerge their hand in ice water for 90 seconds.
Treatment groups
125 Participants
are divided into 1 treatment groupGroup A: Experimental groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in subjective states (stress, anxiety, positive affect)
Participants will self-report the extent to which they have felt stressed, overwhelmed, anxious/nervous, cheerful, and happy during the last 30 minutes before acute stress, immediately after acute stress, and after a recovery period. The Subjective States Questionnaire will be used to score responses. The minimum values are 0 (not at all) and the maximum values are 7 (very strongly). Higher scores mean more stress, more anxiety, and more positive affect.
Time frame
2.5 hours2
Change in cardiovascular activity and cortisol
Saliva will be collected (for later cortisol assays) and cardiovascular activity will be measured before, during, and after acute stress.
Time frame
2.5 hoursSponsors and contacts
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Source ClinicalTrials.gov