Trial · NCT03491384
Anxiety, Inflammation, Stress, and Cannabinoids
NCT03491384, Completed, University of Colorado, Boulder; results first posted 2024-12-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Anxiety, Inflammation, Stress, and Cannabinoids. Trials, record NCT03491384. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03491384
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anxiety, Inflammation, Stress, and Cannabinoids
- NCT number
- NCT03491384
- Status
- Completed
- Enrollment
- 361 participants, actual
- Lead sponsor
- University of Colorado, Boulder
- Conditions
- Anxiety, Anxiety Disorders, Anxiety Generalized, Anxiety Chronic, Inflammation, Inflammatory Response
- Interventions
- Cannabis (smoked flower, ingested edible)
- First posted
- 2018-04-09
- Last updated
- 2025-08-27
- Results first posted
- 2024-12-09
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Anxiety: Depression Anxiety Stress Scale (DASS21). | 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 |
| Primary | Change in Inflammation: Circulating Levels of Cytokines (Panel of Inflammatory Markers). | 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. |
| Primary | Patient Global Impression of Change: Global Impression of Change Scale (PGIC). | 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. |
| Secondary | Cognitive Impairment: NIH Toolbox Cognitive Battery, Flanker Inhibitory Control Attention Task (FICA) and International Shopping List Test (ISLT). | 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) | 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. |
| Secondary | Self-Reported Affect in the Context of Negative Affect Induction Task | Acute change in affect from before the negative affect induction task to post-breathing | 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. |
| Secondary | Change in Depression: Depression Anxiety Stress Scale (DASS21). | 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. 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) |
| Secondary | Health and Wellbeing | 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-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) |
| Secondary | Motor Battery: Balance and Motor Function | 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 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. |
| Secondary | Objective Physical Activity/Exercise | 4 weeks | Physical activity via objective daily data on wearable watch as measured by average minutes of moderate to vigorous physical activity (MVPA). |
| Secondary | Physical Activity/Exercise | 4 weeks | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Anxiety: Depression Anxiety Stress Scale (DASS21). | 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) | units on a scale | MEAN | |
| PRIMARY | Change in Inflammation: Circulating Levels of Cytokines (Panel of Inflammatory Markers). | 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) | Participants were included in inflammatory marker analyses if they had biomarkers available for both timepoints (baseline and 4 weeks). Thus, sample size here is not the same as sample size for self-report based outcomes. | pg/mL | MEAN |
| PRIMARY | Patient Global Impression of Change: Global Impression of Change Scale (PGIC). | 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. | score on a scale | MEAN | |
| SECONDARY | Cognitive Impairment: NIH Toolbox Cognitive Battery, Flanker Inhibitory Control Attention Task (FICA) and International Shopping List Test (ISLT). | 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) | score on a scale | MEAN | |
| SECONDARY | Self-Reported Affect in the Context of Negative Affect Induction Task | Acute change in affect from before the negative affect induction task to post-breathing | score on a scale | MEAN | |
| SECONDARY | Change in Depression: Depression Anxiety Stress Scale (DASS21). | 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) | score on a scale | MEAN | |
| SECONDARY | Health and Wellbeing | 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) | units on a scale | MEAN | |
| SECONDARY | Motor Battery: Balance and Motor Function | 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) | z-score | MEAN | |
| SECONDARY | Objective Physical Activity/Exercise | 4 weeks | minutes | MEAN | |
| SECONDARY | Physical Activity/Exercise | 4 weeks | score on a scale | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group112
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Anxiety: Depression Anxiety Stress Scale (DASS21). | Non-Use | Baseline | 9.38 | Standard Deviation 7.71 | units on a scale |
| Change in Anxiety: Depression Anxiety Stress Scale (DASS21). | THC Group | Baseline | 10.1 | Standard Deviation 6.69 | units on a scale |
| Change in Anxiety: Depression Anxiety Stress Scale (DASS21). | CBD Group | Baseline | 10.5 | Standard Deviation 7.29 | units on a scale |
| Change in Anxiety: Depression Anxiety Stress Scale (DASS21). | THC+CBD Group | Baseline | 9.85 | Standard Deviation 6.31 | units on a scale |
| Change in Anxiety: Depression Anxiety Stress Scale (DASS21). | Non-Use | 4 Weeks | 6.78 | Standard Deviation 6.63 | units on a scale |
| Change in Anxiety: Depression Anxiety Stress Scale (DASS21). | THC Group | 4 Weeks | 7.14 | Standard Deviation 5.57 | units on a scale |
| Change in Anxiety: Depression Anxiety Stress Scale (DASS21). | CBD Group | 4 Weeks | 5.39 | Standard Deviation 4.73 | units on a scale |
| Change in Anxiety: Depression Anxiety Stress Scale (DASS21). | THC+CBD Group | 4 Weeks | 6.33 | Standard Deviation 5.6 | units on a scale |
| Change in Inflammation: Circulating Levels of Cytokines (Panel of Inflammatory Markers). | Non-Use | Baseline | 484.38 | Standard Deviation 1280.36 | pg/mL |
| Change in Inflammation: Circulating Levels of Cytokines (Panel of Inflammatory Markers). | THC Group | Baseline | 110.41 | Standard Deviation 152.31 | pg/mL |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Non-Use | 44 | |
| Overall Study | STARTED | THC Group | 105 | |
| Overall Study | STARTED | CBD Group | 117 | |
| Overall Study | STARTED | THC+CBD Group | 95 | |
| Overall Study | COMPLETED | Non-Use | 42 | |
| Overall Study | COMPLETED | THC Group | 86 | |
| Overall Study | COMPLETED | CBD Group | 92 | |
| Overall Study | COMPLETED | THC+CBD Group | 80 | |
| Overall Study | NOT COMPLETED | Non-Use | 2 | |
| Overall Study | NOT COMPLETED | THC Group | 19 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Non-Use | 0 | 42 |
| Total, all-cause mortality | THC Group | 0 | 86 |
| Total, all-cause mortality | CBD Group | 0 | 92 |
| Total, all-cause mortality | THC+CBD Group | 0 | 80 |
| Total, other adverse events | Non-Use | 0 | 42 |
| Total, other adverse events | THC Group | 0 | 86 |
| Total, other adverse events | CBD Group | 0 | 92 |
| Total, other adverse events | THC+CBD Group | 0 | 80 |
| Total, serious adverse events | Non-Use | 0 | 42 |
| Total, serious adverse events | THC Group | 0 | 86 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03491384
GET https://conductscience.org/api/trials/v1/NCT03491384/results?page=2