An observational study in Anxiety, Anxiety Disorders and Anxiety Generalized, sponsored by University of Colorado, Boulder. Completed at 1 site in United States. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-08-27.
Sponsored by University of Colorado, Boulder · Observational
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.
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.
517 studies on the registry are indexed under Generalized Anxiety Disorder; 124 are open to participants now.
This study's enrollment of 361 is above the median of 270 across 62 observational studies indexed under Generalized Anxiety Disorder.
Browse Generalized Anxiety Disorder studies →University of Colorado, Boulder is the lead sponsor of 88 studies on the registry; 20 are open to participants now.
Compared within Generalized Anxiety Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Community Sample
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Self-Directed Use (ad-libitum)
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
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: 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.
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)
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.
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.
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.
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
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.
Time frame: 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)
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
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)
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
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.
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
Physical activity via objective daily data on wearable watch as measured by average minutes of moderate to vigorous physical activity (MVPA).
Time frame: 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.
Time frame: 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)
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)
Exploratory: Daily Follow-Up Messages
Brief self-report from participants on anxiety and sleep in the past 24 hours. These are all 1-item novel questions in a daily, text based survey. Anxiety and sleep are on a scale of 1-10, with higher numbers being more anxiety or better sleep. Score is an average rating over 30 days.
Time frame: One survey per day for 30 days (at the start of the 4 week study)
Exploratory: Monthly Follow-Up Surveys
Self-report from participants on anxiety (DASS anxiety subscale), sleep (novel sleep quality question ranging from 1-10 and 10 being best sleep), subjective cognitive functioning (perceived cognitive ability from the Functional Assessment of Cancer Therapy-Cognitive Function scale as was already reported in secondary measures- see for full description), and general health health (novel health question as was also reported in secondary measures- see for full description).
Time frame: 5 months (post-study completion)
| Milestone | Non-Use | THC Group | CBD Group | THC+CBD Group |
|---|---|---|---|---|
| Started | 44 | 105 | 117 | 95 |
| Completed | 42 | 86 | 92 | 80 |
| Not completed | 2 | 19 | 25 | 15 |
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
| units on a scale | Non-Use | THC Group | CBD Group | THC+CBD Group |
|---|---|---|---|---|
| Baseline | 9.38 ± 7.71 | 10.1 ± 6.69 | 10.5 ± 7.29 | 9.85 ± 6.31 |
| 4 Weeks | 6.78 ± 6.63 | 7.14 ± 5.57 | 5.39 ± 4.73 | 6.33 ± 5.6 |
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.
| pg/mL | Non-Use | THC Group | CBD Group | THC+CBD Group |
|---|---|---|---|---|
| Baseline | 484.38 ± 1280.36 | 110.41 ± 152.31 | 294.71 ± 501.34 | 324.04 ± 871.24 |
| 4 Week | 62.95 ± 88.15 | 125.62 ± 173.02 | 218.07 ± 487.29 | 338.05 ± 949.23 |
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.
| score on a scale | Non-Use | THC Group | CBD Group | THC+CBD Group |
|---|---|---|---|---|
| Patient Global Impression of Change: Global Impression of Change Scale (PGIC). | 4.4 ± 0.93 | 5.07 ± 0.96 | 5.2 ± 0.73 | 5.24 ± 0.93 |
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.
| score on a scale | Non-Use | THC Group | CBD Group | THC+CBD Group |
|---|---|---|---|---|
| Baseline | 108.753 ± 1.003 | 107.846 ± 9.442 | 109.799 ± 9.453 | 108.218 ± 0.353 |
| 4 Weeks | 112.917 ± 10.676 | 112.451 ± 9.087 | 114.367 ± 9.14 | 112.772 ± 11.357 |
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.
| score on a scale | Non-Use | THC Group | CBD Group | THC+CBD Group |
|---|---|---|---|---|
| Baseline | 34.415 ± 15.56 | 33.518 ± 17.097 | 33.966 ± 14.184 | 33.416 ± 15.25 |
| 4 weeks | 34.805 ± 11.9 | 36.687 ± 14.649 | 36.193 ± 14.448 | 36.147 ± 14.312 |
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)
| score on a scale | Non-Use | THC Group | CBD Group | THC+CBD Group |
|---|---|---|---|---|
| Change in Depression: Depression Anxiety Stress Scale (DASS21). | 10.095 ± 8.588 | 9.442 ± 8.921 | 8.901 ± 8.333 | 8.425 ± 9.144 |
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)
| units on a scale | Non-Use | THC Group | CBD Group | THC+CBD Group |
|---|---|---|---|---|
| Baseline Self Reported Diet | 1.643 ± 0.932 | 1.791 ± 0.883 | 1.857 ± 0.95 | 1.7750 ± 0.914 |
| 4 Week Self Reported Diet | 1.659 ± 0.825 | 1.741 ± 0.804 | 1.811 ± 0.792 | 1.772 ± 0.784 |
| Baseline Sleep Quality | 1.167 ± 0.696 | 1.221 ± 0.582 | 1.348 ± 0.67 | 1.362 ± 0.68 |
| 4 Week Sleep Quality | 1.167 ± 0.537 | 1.14 ± 0.557 | 1.066 ± 0.611 | 1.2 ± 0.582 |
| Baseline Health-Related Wellbeing | 1.238 ± 0.726 | 1.291 ± 0.81 | 1.217 ± 0.724 | 1.275 ± 0.675 |
| 4 Week Health-Related Wellbeing | 1.463 ± 0.745 | 1.338 ± 0.816 | 1.618 ± 0.711 | 1.614 ± 0.748 |
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.
| z-score | Non-Use | THC Group | CBD Group | THC+CBD Group |
|---|---|---|---|---|
| Baseline sum Motor Battery Balance score | 0.0195 ± 0.007 | 0.0192 ± 0.006 | 0.0173 ± 0.005 | 0.0202 ± 0.014 |
| Change in Balance score at 4 weeks | 0.0214 ± 0.011 | 0.0201 ± 0.006 | 0.0182 ± 0.005 | 0.0195 ± 0.007 |
Physical activity via objective daily data on wearable watch as measured by average minutes of moderate to vigorous physical activity (MVPA).
| minutes | Non-Use | THC Group | CBD Group | THC+CBD Group |
|---|---|---|---|---|
| Objective Physical Activity/Exercise | 1711.07 ± 1055.73 | 1751.97 ± 1075.78 | 1487.81 ± 1060.91 | 1712.53 ± 1114.56 |
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.
| score on a scale | Non-Use | THC Group | CBD Group | THC+CBD Group |
|---|---|---|---|---|
| Baseline scores on L-CAT | 3.476 ± 1.234 | 3.523 ± 1.326 | 3.571 ± 1.367 | 3.612 ± 1.392 |
| Change in scores at 4-weeks on L-CAT | 3.415 ± 1.224 | 3.5 ± 1.299 | 3.4 ± 1.234 | 3.481 ± 1.357 |
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)
| score on a scale | Non-Use | THC Group | CBD Group | THC+CBD Group |
|---|---|---|---|---|
| Change in Stress: Depression Anxiety Stress Scale (DASS21). | 13.714 ± 8.572 | 13.023 ± 7.631 | 12.374 ± 7.136 | 12.4 ± 7.99 |
Brief self-report from participants on anxiety and sleep in the past 24 hours. These are all 1-item novel questions in a daily, text based survey. Anxiety and sleep are on a scale of 1-10, with higher numbers being more anxiety or better sleep. Score is an average rating over 30 days.
| units on a scale | Non-Use | THC Group | CBD Group | THC+CBD Group |
|---|---|---|---|---|
| Anxiety Rating | 3.457 ± 2.386 | 3.394 ± 2.102 | 3.51 ± 2.167 | 3.133 ± 2.066 |
| Sleep Quality Rating | 5.687 ± 1.785 | 5.72 ± 1.74 | 5.63 ± 1.818 | 5.455 ± 1.773 |
Self-report from participants on anxiety (DASS anxiety subscale), sleep (novel sleep quality question ranging from 1-10 and 10 being best sleep), subjective cognitive functioning (perceived cognitive ability from the Functional Assessment of Cancer Therapy-Cognitive Function scale as was already reported in secondary measures- see for full description), and general health health (novel health question as was also reported in secondary measures- see for full description).
| units on a scale | Non-Use | THC Group | CBD Group | THC+CBD Group |
|---|---|---|---|---|
| Anxiety | 3.246 ± 3.267 | 3.067 ± 3.15 | 2.844 ± 2.974 | 3.216 ± 3.153 |
| Sleep | 6.145 ± 1.671 | 5.763 ± 1.79 | 5.837 ± 1.708 | 5.595 ± 1.626 |
| Subjective Cognitive Impairment | 4.657 ± 11.058 | 5.756 ± 10.222 | 4.88 ± 7.918 | 7.718 ± 14.185 |
| General Health | 1.455 ± 0.779 | 1.367 ± 0.893 | 1.606 ± 0.745 | 1.588 ± 0.777 |
Collected over Participants were monitored from Baseline to 4 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Non-Use | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| THC Group | 0/86 (0%) | 0/86 (0%) | 0/86 (0%) |
| CBD Group | 0/92 (0%) | 0/92 (0%) | 0/92 (0%) |
| THC+CBD Group | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) |
| Age, Continuous(years) | Non-Use | THC Group | CBD Group | THC+CBD Group | Total |
|---|---|---|---|---|---|
| Mean | 35.3 ± 14.4 | 31.3 ± 11.7 | 29.5 ± 10.9 | 32.3 ± 12.5 | 31.6 ± 12.2 |
| Sex: Female, Male(Participants) | Non-Use | THC Group | CBD Group | THC+CBD Group | Total |
|---|---|---|---|---|---|
| Female | 27 | 50 | 47 | 45 | 169 |
| Male | 15 | 36 | 45 | 35 | 131 |
| Ethnicity (NIH/OMB)(Participants) | Non-Use | THC Group | CBD Group | THC+CBD Group | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 4 | 7 | 5 | 4 | 20 |
| Not Hispanic or Latino | 38 | 79 | 87 | 76 | 280 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Non-Use | THC Group | CBD Group | THC+CBD Group | Total |
|---|---|---|---|---|---|
| United States | 42 | 86 | 92 | 80 | 300 |
| Anxiety: DASS 21(units on a scale) | Non-Use | THC Group | CBD Group | THC+CBD Group | Total |
|---|---|---|---|---|---|
| Mean | 9.38 ± 7.71 | 10.14 ± 6.69 | 10.46 ± 7.29 | 10.14 ± 6.69 | 10.11 ± 6.86 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2018 to primary completion in Dec 2022, 56 months.
Results were first posted in Dec 2024, 1 year 11 months after primary completion.
Of 24 observational studies under Generalized Anxiety Disorder, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 56. This study's 56 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Generalized Anxiety Disorder →
University of Colorado, Boulder