CBDNCT07069478
Cannabidiol (CBD) and Stress Response: Psychobiological Mechanisms
A study testing Stress Intervention in people with CBD and Cannabidiol, run by University of Minnesota at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- CBD, Cannabidiol, Stress
- What is being tested?
- Stress Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
- Non-compliance with instructions for study visit (abstinence from alcohol, caffeine, physical activity, etc.)
- Students of the principal researcher
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Stress and Resilience Research Labs, 218-726-8623, umdbml@d.umn.edu
About this study
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.
- Conditions
- CBD, Cannabidiol, Stress, Acute Stress Reaction
- Being tested
- Stress Intervention
- Keywords
- cardiovascular reactivity, , , ,, hypothalamic-pituitary-adrenal axis, stress, mood, CBD use
- Medical subject headings
- Stress Disorders, Traumatic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress InterventionOther
Experimental 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants will include CBD users and non users Receives: Other: Stress Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2.5 hours
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.
Measured: 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start16 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CBDStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignment; all participants experience baseline rest, acute stress tasks, and recovery rest.
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mustafa al'Absi, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069478
- Sponsor's protocol ID
- DMED-2025-33636
- Status last verified
- Jul 2026
- First submitted
- 28 May 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabidiol (CBD) and Stress Response: Psychobiological Mechanisms
- ClinicalTrials.gov ID
- NCT07069478
- Acronym / sponsor ID
- DMED-2025-33636
- Conditions
- CBD, Cannabidiol, Stress, Acute Stress Reaction
- Keywords
- cardiovascular reactivity, , , ,, hypothalamic-pituitary-adrenal axis, stress, mood, CBD use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment; all participants experience baseline rest, acute stress tasks, and recovery rest.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Stress InterventionParticipants will include CBD users and non users |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
- Non-compliance with instructions for study visit (abstinence from alcohol, caffeine, physical activity, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress 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. | Other | Experimental group |
Primary outcome
Change in subjective states (stress, anxiety, positive affect)
Time frame: 2.5 hours
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.
Change in cardiovascular activity and cortisol
Time frame: 2.5 hours
Saliva will be collected (for later cortisol assays) and cardiovascular activity will be measured before, during, and after acute stress.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
Related trials for CBD
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
Not yet recruitingPhase 1
A Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered Cannabidiol Capsules (AVAT-121) and Epidyolex® in Healthy Adults
Focal Onset Seizure
RecruitingPhase 2/3
Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving
Alcohol Use Disorder (AUD), Withdrawal From Addictive Substance; Detoxification
Active, not recruitingPhase 2
Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder
Alcohol Use Disorder
Not yet recruiting
Effects of Cannabidiol on Memory and Attention in Adults Aged 60-70: A Pilot Study
Healthy Aging, Cognition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mustafa al'Absi principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Intervention in people with CBD and Cannabidiol, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stress and Resilience Research Labs (2187268623, umdbml@d.umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in subjective states (stress, anxiety, positive affect) (time frame: 2.5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.