Anxiety, Inflammation, Stress, and Cannabinoids

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

361 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2023-05-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Effects on Responses to Stress and Pain of Natural Medical Marijuana Products

NCT04226690

Pain

COMPLETED PHASE1

The Effects of Cannabidiol and ∆-9-THC in Humans

NCT01180374

Healthy

COMPLETED EARLY_PHASE1

Effects of THC and CBD on Human Episodic Memory Function

NCT02291562

Healthy Volunteers

COMPLETED NA

Cannabidiol and Emotional Stimuli

NCT02902081

Drug Addiction

COMPLETED NA

Behavioral Pharmacology of THC and D-limonene

NCT03609853

D-limonene and THC Pharmacodynamics

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety Anxiety Disorders Anxiety Generalized Anxiety Chronic Inflammation Inflammatory Response

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cannabis (smoked flower, ingested edible)

Self-Directed Use (ad-libitum)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No