Anxiety, Inflammation, and Stress



Status:Recruiting
Conditions:Anxiety
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:21 - 70
Updated:12/1/2018
Start Date:April 1, 2018
End Date:June 30, 2022
Contact:Leah Hitchcock, PhD
Email:OASIS.CUstudy@gmail.com
Phone:303-492-0288

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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.

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.

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.
We found this trial at
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Boulder, Colorado 80304
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Boulder, CO
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