NCT07069478

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Jun 2025Nov 2026

First Submitted

Initial submission to the registry

May 28, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

May 28, 2025

Last Update Submit

July 7, 2025

Conditions

Keywords

cardiovascular reactivity, , , ,hypothalamic-pituitary-adrenal axisstressmoodCBD use

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    2.5 hours

Study Arms (1)

Experimental group

EXPERIMENTAL

Participants will include CBD users and non users

Other: Stress Intervention

Interventions

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.

Experimental group

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Traumatic, Acute

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Mustafa al'Absi

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stress and Resilience Research Labs

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Single group assignment; all participants experience baseline rest, acute stress tasks, and recovery rest.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2025

First Posted

July 16, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

July 16, 2025

Record last verified: 2025-07

Locations