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NCT03491384 · ClinicalTrials.gov registry record
Anxiety, Inflammation, Stress, and Cannabinoids
A clinical trial, sponsored by University of Colorado, Boulder.
- Completed
- Registry status
- 361
- Enrollment target
NCT03491384: Completed study, sponsored by University of Colorado, Boulder.
NCT03491384 is a clinical trial that has completed, run by University of Colorado, Boulder. The registered enrollment target is 361 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03491384 has completed, sponsored by University of Colorado, Boulder.
- COMPLETED
- Registry status
- 361 participants
- Enrollment target
Study 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.
Primary Outcome
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 Anx
Interventions
- DRUG Cannabis (smoked flower, ingested edible)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 361 participants |
| Start Date | 2018-04-01 |
| Est. Completion | 2023-05-17 |
What the finished NCT03491384 record still lists
NCT03491384 is an observational study that tracks outcomes without assigning an intervention. The registered 361 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Cannabis (smoked flower, ingested edible) is the first listed.
NCT03491384 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03491384 about?
NCT03491384 is a clinical study titled "Anxiety, Inflammation, Stress, and Cannabinoids". 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 t...
What is the current status of trial NCT03491384?
This trial is currently completed. The enrollment target is 361 participants. The study started on 2018-04-01. Estimated completion is 2023-05-17.
What interventions are being tested in trial NCT03491384?
The interventions under investigation include: Cannabis (smoked flower, ingested edible) (DRUG).
Who is sponsoring clinical trial NCT03491384?
This trial is sponsored by University of Colorado, Boulder, which has 69 total clinical trials registered on ClinicalTrials.gov.
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