N/A
N=361
Anxiety, Inflammation, Stress, and Cannabinoids
Anxiety · Anxiety Disorders · Anxiety Generalized · Anxiety Chronic · Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT03491384 ↗Enrolled (actual)
361
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Change in Anxiety: Depression Anxiety Stress Scale (DASS21). — 9.38; 10.1; 10.5; 9.85 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Cannabis (smoked flower, ingested edible) (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Boulder
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Anxiety: Depression Anxiety Stress Scale (DASS21). |
9.38; 10.1; 10.5; 9.85; 6.78; 7.14 | — |
| PRIMARY Change in Inflammation: Circulating Levels of Cytokines (Panel of Inflammatory Markers). |
484.38; 110.41; 294.71; 324.04; 62.95; 125.62 | — |
| PRIMARY Patient Global Impression of Change: Global Impression of Change Scale (PGIC). |
4.4; 5.07; 5.2; 5.24 | — |
| SECONDARY Cognitive Impairment: NIH Toolbox Cognitive Battery, Flanker Inhibitory Control Attention Task (FICA) and International Shopping List Test (ISLT). |
108.753; 107.846; 109.799; 108.218; 112.917; 112.451 | — |
| SECONDARY Self-Reported Affect in the Context of Negative Affect Induction Task |
34.415; 33.518; 33.966; 33.416; 34.805; 36.687 | — |
| SECONDARY Change in Depression: Depression Anxiety Stress Scale (DASS21). |
10.095; 9.442; 8.901; 8.425 | — |
| SECONDARY Health and Wellbeing |
1.643; 1.791; 1.857; 1.7750; 1.659; 1.741 | — |
| SECONDARY Motor Battery: Balance and Motor Function |
0.0195; 0.0192; 0.0173; 0.0202; 0.0214; 0.0201 | — |
| SECONDARY Objective Physical Activity/Exercise |
1711.07; 1751.97; 1487.81; 1712.53 | — |
| SECONDARY Physical Activity/Exercise |
3.476; 3.523; 3.571; 3.612; 3.415; 3.5 | — |
| SECONDARY Change in Stress: Depression Anxiety Stress Scale (DASS21). |
13.714; 13.023; 12.374; 12.4 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03491384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.