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Description:

The purpose of this clinical trial is to research the safety and effectiveness of the cannabinoid CBN (coupled with our full-spectrum Hemp Oil) for dogs with severe anxiety. Before this trial, Dr.Hempdog had already worked with this formula for 18 months with very promising results. Because of that success, we created a formal clinical trial to capture and demonstrate this evidence.

This is the first-ever clinical trial to study the effects of CBN in dogs (that we know of). We are honored to have a group of accomplished veterinarians, dog trainers, and canine wellness professionals taking part in all stages of this trial.

Our first group of 10 dogs is already 90 days into the study. Each dog is receiving daily doses of our proprietary full-spectrum CBN/CBD oil (i.e. our Ultra Behavior Formula). As time goes on, we're adding more groups of dogs to the study.

Why This Research is Important:

Since we started servicing dogs with anxiety back in 2015, we noticed that our full-spectrum hemp oil was very useful for anxiety; however, there were still some dogs in some situations that it wasn't able to fully assist. This frustrated us to no end.

Because of our deep knowledge of cannabinoid science, we've known for a long time that CBN could have a positive influence on anxiety.

Over the years, we started to experiment with CBN on ourselves (like we do with most cannabinoids). After that, we started testing very small, safe doses with a few dogs we knew well that were good candidates. We learned that proper dosing is essential to have success with using this cannabinoid for anxiety, so we extensively studied CBN coupled with combinations of other cannabinoids. Based on this, we developed the most effective formula possible. Our continued experiments were incredibly successful, so we initiated a formal clinical trial to capture and further elaborate on this evidence.

Thanks to advances in the industry, we are now able to legally grow CBN from hemp for this purpose, allowing us to create this potential next-generation cannabinoid product.

Recent Updates & Preliminary Results

*These are brief summaries of overall findings. If you're interested in viewing more detailed data, please reach out to us.

Background, Trial Purpose & the Science Leading Up to This Study

CBN is one of a very small set of cannabinoids that can agonize CB1 receptors in the brain, which is well-documented to be associated with anxiolytic, sedative, and relaxant properties (Morales 2017, Huestis 2005). Other CB1-agonizing cannabinoids include THC and the endocannabinoid Anandamide (colloquially known as the "bliss molecule"). Furthermore, studies into CBN have demonstrated that it may have anxiolytic & sedative properties when combined with other cannabinoids, namely Δ9-Tetrahydrocannabinol (THC) (Takahashi 1975). Of particular note is the fact that CBN's CB1-mediated activities are extremely similar to THC in function, yet are approximately 10 times weaker (Huestis 2005, Hartsel 2019); this means that CBN does not possess the same intoxicating, psychoactive traits as THC. Numerous veterinary safety studies further show that THC is well-tolerated in dogs and other animals when used at appropriate doses, particularly when administered concurrently with CBD and other cannabinoids (Chicoine 2020, Fernández-Trapero 2020); we reason that CBN, being pharmacologically similar to THC (yet much weaker), is therefore likely to be safe in dogs when administered at low doses.

Since we started in this industry, we had noticed that our full-spectrum hemp oil was very useful for anxiety; however, there were some dogs in some situations that our successful product wasn't able to fully assist. We've known for a long time that CBN could potentially have a positive influence on anxiety, as evidenced by several findings in humans and other animals.

The purpose of this clinical trial is to research the safety and effectiveness of the cannabinoid CBN (coupled with our full-spectrum Hemp Oil) for dogs with severe anxiety. This is especially important for animals in this study where no other medicines have fully worked, as this may indicate a novel (and potentially game-changing) therapeutic solution for this situation. Through this trial, we plan to gain a substantial amount of data that will let us see the progress of each animal from week to week and month to month. We hope that the dogs involved will see success in relieving their anxiety and will have improved quality of life; the well-being of the animals involved supercedes all else in this trial.

Study Design & Methodology

Inclusion Criteria

This study population is comprised of dogs from across the United States. Dogs were considered for inclusion into the study based on unmanaged or partially managed symptoms of anxiety. During intake, dogs were then screened to confirm the absence of existing medical conditions that would disallow them to participate in this trial, such as compromised immune systems, neurodegenerative diseases, cardiac abnormalities, etcetera.

Safety Tests / Bloodwork

Before administration of any trial compounds (i.e. UBF), preliminary bloodwork tests were performed on several dogs to gather baseline safety data for liver enzyme function. Blood work panels were repeated at the 90-day mark to evaluate any potential changes in liver enzyme function and overall health.

Data Collection Methodology / Study Process

Prior to administration of UBF, all involved humans participated in multiple intake discussions (via email and phone calls) to:

1. Evaluate baseline conditions for participating dogs:
   • This included basic clerical and medical data, such as eating/sleeping habits, medical history, breed, age, home environment, etc.
2. Identify and quantify the most prevalent anxiety symptoms in each dog. Each human was asked to:
   • Identify the most prevalent symptoms of anxiety in their dogs (whining, biting, self-harm, shaking, attention-seeking, destructive behaviors, barking, etc.). They were then asked to rank the frequency of those symptoms on a scale of 0 - 3 (0 = "Never Displayed," 1 = "Displayed Infrequently," 2 = "Frequently Displayed," 3 = "Almost Always Displayed")
   • Rank the overall severity of their dog's anxiety on a scale of 0 - 10 (0 = "No Anxiety," 10 = "Completely Unmanageable")
   • Rank the overall happiness of their dog on a similar scale of 0 - 10 (0 = "Little to No Happiness," 10 = "Very Happy")

Dogs received controlled daily doses of Ultra Behavior Formula (UBF) which were administered by their humans at home. Humans checked in with study personnel at the 2-day, 7-day, 14-day, and 30-day marks, and then every 30 days after that. During these check-ins, humans answered the same questionnaires, again ranking symptom frequency, anxiety severity, and overall happiness. These check-ins were also used to evaluate any potential dose adjustments.

Dosing Methodology

All dogs started at a preliminary safety dose of 1 drop* per 10 lbs for the first week of administration. After one week, all involved dogs moved up to a baseline dose of 2 drops per 10 lbs. As check-ins continued, some doses were further increased on a case-by-case basis depending on symptom severity and reduction.

*One drop of UBF contains 0.025mg CBN, 0.425mg CBD, and 0.033mg other supporting cannabinoids.

Dogs were administered UBF orally, mixed into their meals. Participating humans ensured that each dog ingested their full dose within approximately 5 minutes.

Who's Involved

We're honored to have built an expansive, multi-disciplinary team of experts for this trial, including:

• Veterinarians

• Professional Dog Trainers

• Canine Wellness Practitioners

• The Dr.Hempdog Science Team

• A Variety of Dogs with Challenging Anxiety Cases

Frequently Asked Questions