AnxietyNCT03491384
Anxiety, Inflammation, Stress, and Cannabinoids
An observational study of Anxiety and Anxiety Disorders, run by University of Colorado, Boulder at 1 site in United States.
Trial summary
This study investigates whether the anxiolytic effects and anti-inflammatory properties of cannabis vary as a function of the ratio of CBD to THC, with the goal that these effects may shed light on the mixed data linking cannabis use and anxiety. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Anxiety, Anxiety Disorders, Anxiety Generalized
- What is being tested?
- Cannabis (smoked flower, ingested edible)
- How many people
- 361 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 17 May 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Study population: Community Sample
Who may be able to join
- Non-users of cannabis must have been a non-user of cannabis for at least six months
- If a user of cannabis, at least one episode of lifetime cannabis use and a desire to use cannabis to cope with anxiety.
- Reports at least mild to moderate anxiety (≥5 on GAD-7)
Who cannot join
- Seeking treatment for a substance use disorder
- Current use of other drugs (e.g., cocaine, methamphetamine)
- Current use psychotropic or steroid-based medications
- Has an immune-relevant disease (e.g. HIV)
- Daily tobacco user
- Currently pregnant or trying to become pregnant
- In treatment for psychotic disorder, bipolar disorder or major depression disorder with suicidal ideation; or a history with these disorders.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Innovation and Creativity
Boulder, Colorado, 80304
About this study
Official title: Novel Approaches to Understanding the Role of Cannabinoids and Inflammation in Anxiety
This study investigates whether the anxiolytic effects and anti-inflammatory properties of cannabis vary as a function of the ratio of CBD to THC, with the goal that these effects may shed light on the mixed data linking cannabis use and anxiety. Individuals with mild to moderate anxiety who elect to use cannabis (smoked flower or edible) will complete four weeks of observation. Participants complete cognitive tasks, a substance use history, health questionnaires concerning sleep and physical activity, and a blood draw at four different time points (Baseline, after 2 weeks of cannabis use, and immediately before and after self-administration after 4 weeks of use) with the use of a mobile pharmacology laboratory, which goes to a convenient location for each participant to self-administer their cannabis. Participants are then followed for five months to self-report on cannabis use, anxiety, subjective cognitive functioning, sleep quality, and other mental health symptoms.
Read the detailed description
Marijuana use is on the rise with the number of adults reporting medical and recreational use doubling in the past decade. Among adult medical marijuana users, 39% report using marijuana for the purposes of self-treating or coping with anxiety. Marijuana is approved for medical use in over half the states and is gaining traction for use as an "off-label" add-on therapy for treatment-resistant anxiety and stress-related disorders. Paradoxically, however, while data suggest that marijuana, in particular ∆9-tetrahydrocannabinol (THC), increases anxiety acutely, cross sectional and longitudinal data suggest associations between marijuana use and lower risk for anxiety disorders.
There is some evidence demonstrating that marijuana use is associated with increases in acute anxiety and anxiety disorders. However, other data suggests that marijuana use may be protective for adolescents at-risk for anxiety and decrease the chances of developing an anxiety disorder during college. This finding is consistent with a growing body of evidence from animal models suggesting that marijuana has anxiolytic and anti-inflammatory properties. Clarifying the anxiolytic effects of specific strains that differ in their cannabinoid composition may explain these discrepant findings. Thus, regardless of whether results support or refute the anxiolytic properties of marijuana, findings from this study fill a critical void and can inform public perception.
The study goal is to understand the anxiolytic effects of cannabinoids, in particular the effects of THC-based strains vs. CBD-based strains vs strains containing both THC and CBD in different ratios (1:0, 1:1, or 0:1) on inflammation, cognitive functioning, and anxiety/negative affect. This design will capitalize on the novel opportunity to examine the effects of real world marijuana strains on key outcomes.
- Conditions
- Anxiety, Anxiety Disorders, Anxiety Generalized, Anxiety Chronic, Inflammation, Inflammatory Response
- Being tested
- Cannabis (smoked flower, ingested edible)
- Keywords
- anxiety, inflammation, cannabis, marijuana, stress
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder, Inflammation, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis (smoked flower, ingested edible)Drug
Self-Directed Use (ad-libitum)
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety: Depression Anxiety Stress Scale (DASS21).
The DASS21 is a 21-item scale that measures self-reported change in anxiety, depression, and stress symptoms. Participants are asked to use 4-point severity/frequency scales (higher values indicate greater severity) to rate the extent to which they have experienced each state. Scores for Depression, Anxiety and Stress are calculated by summing the scores for the relevant items. Changes in DASS subscale self-report will be tested in relation to THC and CBD blood levels. For this aim, only the Anxiety subscale was used.
Anxiety subscale score range 0-42 Normal 0-6; Mild 7-9; Moderate 10-14; Severe 15-19; Extremely severe 20-42
Measured: Change from baseline to 4 weeks: Baseline (before 4 weeks of cannabis use) and Post-Administration (after 4 weeks of use and after acute self-administration)
Change in Inflammation: Circulating Levels of Cytokines (Panel of Inflammatory Markers).
Change in inflammation from before to after cannabis use will be tested in relation to THC and CBD blood levels.
The sum concentration of the cytokines IL-1a, IL-1b, IL-6, IL-8, IL-12, and TNFα, which are generally regarded as pro-inflammatory, will be utilized.
The range for these values can be from 0 to infinity. Higher values indicate higher (worse) levels of inflammation.
Measured: Change from baseline to 4 weeks: Baseline (before 4 weeks of cannabis use) and Post-Administration (after 4 weeks of use and after acute self-administration)
Patient Global Impression of Change: Global Impression of Change Scale (PGIC).
Patient Global Impression of Change Scale (PGIC) measures self-reported change on a 1-7 scale (i.e. from 1 (very much worse) to 7 (very much improved) in anxiety. Changes in this measure will be tested in relation to THC and CBD blood levels.
Scale possible score range 0-7, with higher scores indicating the largest amount of possible change.
Measured: This was administered only once, at the 4 week timepoint, asking participants to reflect on how much change they had experienced over the past 4 weeks.
Secondary outcomes (8)
Cognitive Impairment: NIH Toolbox Cognitive Battery, Flanker Inhibitory Control Attention Task (FICA) and International Shopping List Test (ISLT).
Co-outcomes testing multiple domains of thinking, memory, and perception (NIH Toolbox), cognitive impairment in the domains of immediate and delayed recall (ISLT), attention and inhibitory control (FICA). Cognitive outcomes are measured in standard scores (e.g. Range of >70 to >140 (Mean of 100 and SD of 15) with higher scores indicating better performance) and can be averaged to reflect a Standard score of overall cognitive function.
Measured: Change from baseline to 4 weeks: Baseline (before 4 weeks of cannabis use) and Post-Administration (after 4 weeks of use and after acute self-administration)
Self-Reported Affect in the Context of Negative Affect Induction Task
Participants reported levels of negative affect on a novel scale from -50 (worst) to +50 (best) while undergoing a guided rumination to induce negative affect.
Measured: Acute change in affect from before the negative affect induction task to post-breathing
Change in Depression: Depression Anxiety Stress Scale (DASS21).
The DASS21 is a 21-item scale that measures self-reported change in anxiety, depression, and stress symptoms. Participants are asked to use 4-point severity/frequency scales (higher values indicate greater severity) to rate the extent to which they have experienced each state. For this aim, only the Depression subscale was used.
Depression subscale score range 0-21 Normal (0 to 4), Mild (5 to 6), Moderate, (7 to 10), Severe (11 to 13), Extremely Severe (14 and above)
Measured: Change from baseline to 4 weeks: Baseline (before 4 weeks of cannabis use) and Post-Administration (after 4 weeks of use and after acute self-administration)
Health and Wellbeing
Self-report measure across primary domains of diet, assessment of sleep quality, and health-related well-being. Each domain was assessed with the following single items:
Diet: "In general, how healthy is your overall diet? Would you say" (response options 0- excellent; 1- very good; 2- good; 3- fair; 4- poor) Sleep Quality: "During the past 2 weeks, how would you rate your sleep quality overall?" (response options 0- very good; 1- fairly good; 2- fairly bad; 3- very bad") Health Related Wellbeing: "In general, how would you describe your health?" (response options 0- excellent; 1- very good; 2- good; 3- fair; 4- poor)
Measured: Change from baseline to 4 weeks: Baseline (before 4 weeks of cannabis use) and Post-Administration (after 4 weeks of use and after acute self-administration)
Motor Battery: Balance and Motor Function
Motor control assessed via dynamic sway, proprioception, and finger tapping rate. Motor outcomes can be aggregated via Z-score to reflect a Z-score of overall motor function. We calculated the sum of Motor Battery Balance (Eyes Open, Eyes Closed, and Head Back) z-scores. A score of 0 means a participant's balance is at the mean for the sample. Higher scores (scores greater than 0) correspond to worse balance compared to the sample. Scores lower than 0 indicate better balance compared to the sample.
Measured: Change from baseline to 4 weeks: Baseline (before 4 weeks of cannabis use) and Post-Administration (after 4 weeks of use and after acute self-administration)
Objective Physical Activity/Exercise
Physical activity via objective daily data on wearable watch as measured by average minutes of moderate to vigorous physical activity (MVPA).
Measured: 4 weeks
Physical Activity/Exercise
Physical activity via subjective self-report data using the Stanford Leisure-Time Activity Categorical item with 6 item responses (L-CAT; 1-6). Scores are reported as a mean between 1 and 6, larger numbers correspond to higher levels of activity.
Measured: 4 weeks
Change in Stress: Depression Anxiety Stress Scale (DASS21).
The DASS21 is a 21-item scale that measures self-reported change in anxiety, depression, and stress symptoms. Participants are asked to use 4-point severity/frequency scales (higher values indicate greater severity) to rate the extent to which they have experienced each state. For this aim, only the Stress subscale was used.
Stress subscale score range 0-33 Normal (0 to 14), Mild (15 to 18), Moderate, (19 to 25), Severe (26 to 33)
Measured: Change from baseline to 4 weeks: Baseline (before 4 weeks of cannabis use) and Post-Administration (after 4 weeks of use and after acute self-administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start1 Apr 2018
- Primary completion30 Dec 2022
- Study completion17 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Principal investigator, L. Cinnamon Bidwell, University of Colorado, Boulder
- Investigators
- Cinnamon Bidwell, PhD, Principal investigator, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491384
- Sponsor's protocol ID
- R01DA04413
- Status last verified
- Aug 2025
- First submitted
- 28 Feb 2018
- Last updated
- 27 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lisano JK, Rosa L, Giordano G, Bryan AD, Bidwell LC. Physical Activity Level Moderates Cannabis-Associated Reductions in Negative Affect in Anxious Individuals. Clin Ther. 2026 Sep;48(9):859-866. doi: 10.1016/j.clinthera.2026.02.007. Epub 2026 Mar 20.
PubMed 41864773Martin-Willett R, Skrzynski CJ, Bryan AD, Bidwell LC. Effects of Cannabinoids on Emotional States and Alcohol Use Among Underrepresented Groups: Moderation by Perceived Discrimination. Hum Psychopharmacol. 2025 Sep;40(5):e70016. doi: 10.1002/hup.70016.
PubMed 40916181Skrzynski CJ, Rosa L, Drake A, Bryan AD, Bidwell LC. Experimental study on cannabis use and affect: Effects on reactivity to and recovery from negative stimuli. J Psychopathol Clin Sci. 2025 Aug;134(6):639-650. doi: 10.1037/abn0001023. Epub 2025 Jun 16.
PubMed 40522823Bidwell LC, Martin-Willett R, Skrzynski C, Lisano J, Ortiz Torres M, Giordano G, Hutchison KE, Bryan AD. Acute and Extended Anxiolytic Effects of Cannabidiol in Cannabis Flower: A Quasi-Experimental ad libitum Use Study. Cannabis Cannabinoid Res. 2024 Aug;9(4):1015-1027. doi: 10.1089/can.2023.0187. Epub 2024 Jan 22.
PubMed 38252547
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Approaches to Understanding the Role of Cannabinoids and Inflammation in Anxiety
- ClinicalTrials.gov ID
- NCT03491384
- Acronym / sponsor ID
- R01DA04413
- Conditions
- Anxiety, Anxiety Disorders, Anxiety Generalized, Anxiety Chronic, Inflammation, Inflammatory Response
- Keywords
- anxiety, inflammation, cannabis, marijuana, stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 9 Apr 2018 (actual)
- Results
- Posted 9 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates whether the anxiolytic effects and anti-inflammatory properties of cannabis vary as a function of the ratio of CBD to THC, with the goal that these effects may shed light on the mixed data linking cannabis use and anxiety. Individuals with mild to moderate anxiety who elect to use cannabis (smoked flower or edible) will complete four weeks of observation. Participants complete cognitive tasks, a substance use history, health questionnaires concerning sleep and physical activity, and a blood draw at four different time points (Baseline, after 2 weeks of cannabis use, and immediately before and after self-administration after 4 weeks of use) with the use of a mobile pharmacology laboratory, which goes to a convenient location for each participant to self-administer their cannabis. Participants are then followed for five months to self-report on cannabis use, anxiety, subjective cognitive functioning, sleep quality, and other mental health symptoms.
Detailed description
Marijuana use is on the rise with the number of adults reporting medical and recreational use doubling in the past decade. Among adult medical marijuana users, 39% report using marijuana for the purposes of self-treating or coping with anxiety. Marijuana is approved for medical use in over half the states and is gaining traction for use as an "off-label" add-on therapy for treatment-resistant anxiety and stress-related disorders. Paradoxically, however, while data suggest that marijuana, in particular ∆9-tetrahydrocannabinol (THC), increases anxiety acutely, cross sectional and longitudinal data suggest associations between marijuana use and lower risk for anxiety disorders.
There is some evidence demonstrating that marijuana use is associated with increases in acute anxiety and anxiety disorders. However, other data suggests that marijuana use may be protective for adolescents at-risk for anxiety and decrease the chances of developing an anxiety disorder during college. This finding is consistent with a growing body of evidence from animal models suggesting that marijuana has anxiolytic and anti-inflammatory properties. Clarifying the anxiolytic effects of specific strains that differ in their cannabinoid composition may explain these discrepant findings. Thus, regardless of whether results support or refute the anxiolytic properties of marijuana, findings from this study fill a critical void and can inform public perception.
The study goal is to understand the anxiolytic effects of cannabinoids, in particular the effects of THC-based strains vs. CBD-based strains vs strains containing both THC and CBD in different ratios (1:0, 1:1, or 0:1) on inflammation, cognitive functioning, and anxiety/negative affect. This design will capitalize on the novel opportunity to examine the effects of real world marijuana strains on key outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community Sample
Key inclusion criteria (3 listed)
- Non-users of cannabis must have been a non-user of cannabis for at least six months
- If a user of cannabis, at least one episode of lifetime cannabis use and a desire to use cannabis to cope with anxiety.
- Reports at least mild to moderate anxiety (≥5 on GAD-7)
Key exclusion criteria (7 listed)
- Seeking treatment for a substance use disorder
- Current use of other drugs (e.g., cocaine, methamphetamine)
- Current use psychotropic or steroid-based medications
- Has an immune-relevant disease (e.g. HIV)
- Daily tobacco user
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 |
|---|---|---|
| Cannabis (smoked flower, ingested edible)Self-Directed Use (ad-libitum) | Drug | – |
Primary outcome
Change in Anxiety: Depression Anxiety Stress Scale (DASS21).
Time frame: Change from baseline to 4 weeks: Baseline (before 4 weeks of cannabis use) and Post-Administration (after 4 weeks of use and after acute self-administration)
The DASS21 is a 21-item scale that measures self-reported change in anxiety, depression, and stress symptoms. Participants are asked to use 4-point severity/frequency scales (higher values indicate greater severity) to rate the extent to which they have experienced each state. Scores for Depression, Anxiety and Stress are calculated by summing the scores for the relevant items. Changes in DASS subscale self-report will be tested in relation to THC and CBD blood levels. For this aim, only the Anxiety subscale was used. Anxiety subscale score range 0-42 Normal 0-6; Mild 7-9; Moderate 10-14; Severe 15-19; Extremely severe 20-42
Change in Inflammation: Circulating Levels of Cytokines (Panel of Inflammatory Markers).
Time frame: Change from baseline to 4 weeks: Baseline (before 4 weeks of cannabis use) and Post-Administration (after 4 weeks of use and after acute self-administration)
Change in inflammation from before to after cannabis use will be tested in relation to THC and CBD blood levels. The sum concentration of the cytokines IL-1a, IL-1b, IL-6, IL-8, IL-12, and TNFα, which are generally regarded as pro-inflammatory, will be utilized. The range for these values can be from 0 to infinity. Higher values indicate higher (worse) levels of inflammation.
Patient Global Impression of Change: Global Impression of Change Scale (PGIC).
Time frame: This was administered only once, at the 4 week timepoint, asking participants to reflect on how much change they had experienced over the past 4 weeks.
Patient Global Impression of Change Scale (PGIC) measures self-reported change on a 1-7 scale (i.e. from 1 (very much worse) to 7 (very much improved) in anxiety. Changes in this measure will be tested in relation to THC and CBD blood levels. Scale possible score range 0-7, with higher scores indicating the largest amount of possible change.
8 secondary outcomes
Cognitive Impairment: NIH Toolbox Cognitive Battery, Flanker Inhibitory Control Attention Task (FICA) and International Shopping List Test (ISLT).
Time frame: Change from baseline to 4 weeks: Baseline (before 4 weeks of cannabis use) and Post-Administration (after 4 weeks of use and after acute self-administration)
Self-Reported Affect in the Context of Negative Affect Induction Task
Time frame: Acute change in affect from before the negative affect induction task to post-breathing
Change in Depression: Depression Anxiety Stress Scale (DASS21).
Time frame: Change from baseline to 4 weeks: Baseline (before 4 weeks of cannabis use) and Post-Administration (after 4 weeks of use and after acute self-administration)
Health and Wellbeing
Time frame: Change from baseline to 4 weeks: Baseline (before 4 weeks of cannabis use) and Post-Administration (after 4 weeks of use and after acute self-administration)
Motor Battery: Balance and Motor Function
Time frame: Change from baseline to 4 weeks: Baseline (before 4 weeks of cannabis use) and Post-Administration (after 4 weeks of use and after acute self-administration)
Objective Physical Activity/Exercise
Time frame: 4 weeks
Physical Activity/Exercise
Time frame: 4 weeks
Change in Stress: Depression Anxiety Stress Scale (DASS21).
Time frame: Change from baseline to 4 weeks: Baseline (before 4 weeks of cannabis use) and Post-Administration (after 4 weeks of use and after acute self-administration)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41864773Lisano JK, Rosa L, Giordano G, Bryan AD, Bidwell LC. Physical Activity Level Moderates Cannabis-Associated Reductions in Negative Affect in Anxious Individuals. Clin Ther. 2026 Sep;48(9):859-866. doi: 10.1016/j.clinthera.2026.02.007. Epub 2026 Mar 20.
- Derived from this study: PubMed 40916181Martin-Willett R, Skrzynski CJ, Bryan AD, Bidwell LC. Effects of Cannabinoids on Emotional States and Alcohol Use Among Underrepresented Groups: Moderation by Perceived Discrimination. Hum Psychopharmacol. 2025 Sep;40(5):e70016. doi: 10.1002/hup.70016.
- Derived from this study: PubMed 40522823Skrzynski CJ, Rosa L, Drake A, Bryan AD, Bidwell LC. Experimental study on cannabis use and affect: Effects on reactivity to and recovery from negative stimuli. J Psychopathol Clin Sci. 2025 Aug;134(6):639-650. doi: 10.1037/abn0001023. Epub 2025 Jun 16.
- Derived from this study: PubMed 38252547Bidwell LC, Martin-Willett R, Skrzynski C, Lisano J, Ortiz Torres M, Giordano G, Hutchison KE, Bryan AD. Acute and Extended Anxiolytic Effects of Cannabidiol in Cannabis Flower: A Quasi-Experimental ad libitum Use Study. Cannabis Cannabinoid Res. 2024 Aug;9(4):1015-1027. doi: 10.1089/can.2023.0187. Epub 2024 Jan 22.
- OASIS Website, CU Change Lab, University of Colorado-BoulderLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Cinnamon Bidwell, PhD principal investigator
University of Colorado, Boulder
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Anxiety Disorders, run by University of Colorado, Boulder 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 7 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: finished, as of the sponsor's last update on 27 Aug 2025. 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?
Yes. Results are posted in the registry (first posted 9 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety: Depression Anxiety Stress Scale (DASS21). (time frame: Change from baseline to 4 weeks: Baseline (before 4 weeks of cannabis use) and Post-Administration (after 4 weeks of use and after acute self-administration)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03491384, which also lists 4 linked publications.
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 27 Aug 2025.