Avicanna Launches Phase I Clinical Trial to Determine Optimal THC Dosing for Anxiety Treatment
Key Insights
Avicanna (search) has initiated a Phase I randomized, double-blind, placebo-controlled trial at the University of Calgary to evaluate dose-dependent effects of oral THC on anxiety (search) and stress (search) in 24 healthy adults.
The study will test three different THC doses (6mg, 9mg, and 15mg) using Avicanna (search)'s proprietary AVCN319301b (search) capsules featuring Solid Self-Emulsifying Drug Delivery System technology.
Primary endpoints focus on validated psychometric assessments of anxiety (search) and subjective response, with secondary measures including mood, cardiovascular parameters, and pharmacokinetic profiling.
Avicanna (search) Inc. has announced the initiation of a Phase I clinical trial at the University of Calgary's Cumming School of Medicine to evaluate the dose-dependent effects of oral THC on anxiety (search) and stress (search). The randomized, double-blind, placebo-controlled crossover study represents a significant step in establishing evidence-based dosing guidelines for cannabinoid-based anxiety treatments.
Study Design and Objectives
The single-site trial will enroll 24 healthy adult participants who will receive single oral doses of THC across separate study visits at 6 mg, 9 mg, and 15 mg, as well as placebo, with washout periods between dosing sessions. The study is led by Dr. Leah Mayo, Assistant Professor, and supported by Dr. Matthew Hill, Professor at the University of Calgary.
Primary endpoints focus on validated psychometric assessments of anxiety (search) and subjective response. Secondary endpoints include measures of mood and intoxication, cardiovascular parameters, circulating stress (search) biomarkers, endocannabinoid system (search) markers, and pharmacokinetic profiling. The trial is designed to generate high-resolution dose response data to better define the therapeutic window of oral THC and to characterize interindividual variability in response.
Proprietary Drug Delivery Technology
The trial utilizes Avicanna (search)'s proprietary AVCN319301b (search) THC capsules, which incorporate the company's Solid Self-Emulsifying Drug Delivery System (SEDDs) technology. This formulation approach addresses a key challenge in cannabinoid therapeutics: due to the highly lipophilic nature and poor water-solubility of cannabinoids, typical cannabis formulations have poor absorption and variability of onset.
Avicanna (search)'s oral delivery systems offer an effective route for non-invasive and non-inhalation administration of cannabinoids. The proprietary capsules are also enrolled in a previously announced pilot phase II randomized controlled trial for osteoarthritis (search) with the University Health Network, demonstrating the versatility of the platform across multiple therapeutic indications.
Clinical Development Pipeline
"We are pleased to be expanding our clinical collaborations with the University of Calgary and to be working alongside Dr. Hill and Dr. Mayo, who are internationally recognized for their contribution to cannabinoid science and anxiety (search) research," stated Dr. Karolina Urban, Executive Vice President of Medical and Scientific Affairs at Avicanna (search). "This Trial represents our second randomized controlled trial that is evaluating our proprietary capsule and marks another important step in advancing our pharmaceutical development pipeline through rigorous, investigator-led research."
The SEDDs technology has demonstrated robustness and versatility through different drug delivery formats including several commercial products such as liquid infuser drops, capsules and an extensive pipeline of products currently in commercialization stage.
Addressing Therapeutic Gaps
The study addresses a critical need in cannabinoid medicine by providing systematic dose-response data for THC in anxiety (search) treatment. The crossover design allows each participant to serve as their own control, potentially reducing variability and improving the precision of dose-response relationships. The inclusion of comprehensive biomarker assessments, including endocannabinoid system (search) markers and pharmacokinetic profiling, will provide valuable insights into the mechanisms underlying THC's anxiolytic effects and individual response variability.