Exploring the Benefits and Safety of Nano-particle CBD for Anxiety Treatment
What is this All About?
Anxiety disorders are some of the most common mental health issues around the world. In 2019, about 301 million people were affected by these conditions. Approximately 31.1% of adults will experience an anxiety disorder at some point in their lives. However, only about 36.9% of those suffering from anxiety disorders seek treatment, leaving a significant 63.1% untreated. Despite various treatment options, many current therapies don’t work well enough, leave some symptoms untreated, or cause unpleasant side effects. This is why new and effective treatments, such as cannabidiol anxiety treatment, are needed. One promising treatment is cannabidiol (CBD), a non-psychoactive component of cannabis. This blog explores a recent study that examined the effectiveness, safety, and pharmacokinetics (how a drug moves through the body) of a nanodispersible CBD oral solution for treating mild to moderate anxiety.
Study Overview
Background and Relevance
The number of people with anxiety disorders is growing, and many existing treatments can lead to addiction or other serious side effects. Common treatments for anxiety, such as benzodiazepines and certain antidepressants, can be effective but are also associated with dependency, withdrawal symptoms, and other adverse effects. Cannabidiol (CBD) offers a potential alternative that may provide effective relief with fewer risks.
This study aimed to evaluate how well a nanodispersible CBD oral solution works and how safe it is for treating anxiety. Specifically, the study compared the outcomes of participants who used the nanodispersible CBD solution to those who received a placebo (a substance with no therapeutic effect). Researchers used standardized measures, known for their sensitivity and reliability, to detect real differences in anxiety levels and other related symptoms between the two groups.
Study Design and Methodology
This phase III study, titled “Evaluation of the efficacy, safety, and pharmacokinetics of nanodispersible cannabidiol oral solution (150 mg/mL) versus placebo in mild to moderate anxiety subjects,” was designed as a randomized, double-blind, placebo-controlled trial, which is considered the gold standard in scientific research. In a randomized trial, participants are randomly assigned to different groups to ensure that the groups are comparable and to minimize bias. Double-blind means that neither the participants nor the researchers know who is receiving the treatment or the placebo, which helps prevent bias in reporting and assessing outcomes. A placebo-controlled trial involves one group receiving the treatment and another group receiving an inactive substance (placebo) to compare the effects accurately.
The study involved 178 participants with mild to moderate anxiety disorders. These participants were randomly assigned to receive either the nanodispersible CBD solution or the placebo. The study lasted 15 weeks and included comprehensive assessments using several standardized tools. These tools included the Generalized Anxiety Disorder-7 (GAD-7) and the Hamilton Anxiety Rating Scale (HAM-A), which are widely used and validated measures for assessing anxiety symptoms.
Key Measures and Comparisons
– GAD-7 Scores: The GAD-7 is a brief measure that assesses the severity of generalized anxiety disorder symptoms. It is sensitive to changes in anxiety levels and can detect differences over time.
– HAM-A Scores: The HAM-A is another widely used scale that measures the severity of anxiety symptoms. It provides a more detailed assessment and is often used in clinical research to evaluate treatment outcomes.
Researchers collected data at the beginning of the study (baseline) and at various points throughout the treatment period. By comparing the changes in GAD-7 and HAM-A scores between the CBD group and the placebo group, the study could accurately determine the effectiveness of the CBD treatment.
Comparison of the Groups
– CBD Group: Participants who received the nanodispersible CBD solution showed significant improvements in their anxiety scores. The mean GAD-7 score decreased from 11.8 at baseline to 4.8 at the end of treatment. The mean HAM-A score dropped from 18.9 to 7.34.
– Placebo Group: In contrast, participants in the placebo group did not show significant changes in their anxiety scores. The mean GAD-7 score remained almost the same, starting at 11.2 and ending at 11.8. Similarly, the mean HAM-A score stayed relatively unchanged, starting at 18.2 and ending at 18.9.
The significant differences in scores between the CBD and placebo groups highlight the effectiveness of the nanodispersible CBD solution. The use of standardized measures ensured that these differences were accurately detected, providing robust evidence of the treatment’s efficacy.
Gold Standard of Research
The design of this study adheres to the highest standards of scientific research. Randomized, double-blind, placebo-controlled trials are considered the gold standard because they minimize bias, allow for clear comparisons, and provide reliable evidence of a treatment’s efficacy and safety. By following this rigorous design, the study offers strong and credible evidence that nanodispersible CBD can effectively reduce anxiety symptoms in individuals with mild to moderate anxiety disorders.
Hold Up: What is Nanodispersible?!
Nanodispersible refers to a formulation technology that allows a substance, such as a drug, to be broken down into extremely small particles, often at the nanoscale (typically less than 100 nanometers in size). These nanoparticles can be easily dispersed in a solution, leading to several potential benefits:
- Improved Solubility: Nanodispersible formulations can enhance the solubility of substances that are poorly water-soluble, making them more effective when taken orally.
- Enhanced Absorption: The small size of nanoparticles allows them to be absorbed more efficiently in the body, leading to better bioavailability (the degree and rate at which a drug is absorbed into the bloodstream).
- Targeted Delivery: Nanoparticles can be engineered to target specific cells or tissues in the body, potentially reducing side effects and increasing the therapeutic effectiveness of the drug.
- Controlled Release: These formulations can be designed to release the drug over a controlled period, ensuring a more consistent therapeutic effect.
In the context of this study, nanodispersible cannabidiol oral solution means that the CBD has been formulated into nanoparticles that can be dispersed in a solution, enhancing its solubility, absorption, and overall effectiveness in treating anxiety.
Key Findings and Takeaways
Efficacy of Cannabidiol Anxiety Treatment
1. Reduction in Anxiety Scores: The study found that the group taking the CBD solution had a significant reduction in anxiety scores compared to the placebo group. The mean GAD-7 score dropped from 11.8 at the start to 4.8 at the end of the treatment in the CBD group. Similarly, the HAM-A score decreased from 18.9 to 7.34.
2. Secondary Outcomes: The study also showed improvements in secondary outcomes such as the Clinical Global Impression-Improvement (CGI-I), Clinical Global Impression-Severity (CGI-S), Patient Health Questionnaire-9 (PHQ-9), and Pittsburgh Sleep Quality Index (PSQI). This suggests that cannabidiol anxiety treatment not only helps with anxiety but also improves symptoms of depression and sleep quality.
3. Safety and Tolerability: The CBD solution was well-tolerated, and no serious side effects were reported. This highlights the safety of using nanodispersible CBD as a treatment for anxiety.
Mechanisms of Action
Although the study did not go into great detail about how CBD works, it mentioned that CBD interacts with various receptors and neurotransmitter systems in the body that are involved in anxiety regulation. This interaction is likely why CBD has minimal side effects. The ways in which CBD works are fairly well studied, although while we have a clear view of some of the receptors and ways that CBD impacts the body with benefit, we have only scratched the surface of a complete understanding.
For anyone looking for info about the mechanism of action of CBD, try these two:
1. Pertwee, R.G., 2008. The diverse CB1 and CB2 receptor pharmacology of three plant cannabinoids: delta9-tetrahydrocannabinol, cannabidiol, and delta9-tetrahydrocannabivarin. British Journal of Pharmacology, 153(2), pp.199-215.
– This paper provides an in-depth look at the pharmacology of cannabinoids, including CBD, and their interactions with CB1 and CB2 receptors in the human body. It explores the various physiological effects and mechanisms through which these compounds exert their influence.
2. Ibeas Bih, C., Chen, T., Nunn, A.V., Bazelot, M., Dallas, M., and Whalley, B.J., 2015. Molecular targets of cannabidiol in neurological disorders. Neurotherapeutics, 12(4), pp.699-730.
– This review article discusses the multiple molecular targets of CBD, including its interaction with receptors, ion channels, and enzymes. It provides a comprehensive overview of how CBD affects neurological processes and its potential therapeutic applications.
Click Here to read the full book, “CBD: What Does The Science Say”
Or for more books: Click Here
For the full CED Clinic Library: CED Clinic Library
Or the Searchable Google Drive version: bit.ly/CEDarchive
Scalability and Future Potential
The positive results from this study suggest that the nanodispersible CBD oral solution could be used more widely in clinical settings. Its effectiveness in treating anxiety and related symptoms indicates potential applications for other psychiatric disorders.
The Details of the Findings
Primary Outcome Measures
GAD-7 Scores
– Baseline: At the start of the study, the average GAD-7 score for the CBD group was 11.8, while the placebo group had an average score of 11.2.
– End of Treatment: By the end of the treatment, the average GAD-7 score in the CBD group had dropped significantly to 4.8. The placebo group’s score remained almost the same at 11.8.
– Significance: The difference in GAD-7 scores between the CBD and placebo groups was −7.02, with a p-value of <0.0001. A p-value indicates the probability that the results happened by chance. A p-value of less than 0.05 typically means the results are statistically significant. So, a p-value of <0.0001 means the reduction in anxiety symptoms in the CBD group was highly significant.
HAM-A Scores
– Baseline: The average HAM-A score at the beginning was 18.9 for the CBD group and 18.2 for the placebo group.
– End of Treatment: The average HAM-A score in the CBD group dropped to 7.34, while the placebo group’s score remained nearly unchanged at 18.9.
– Significance: The difference in HAM-A scores between the CBD and placebo groups was −11.9, with a p-value of <0.0001. This also indicates a highly significant reduction in anxiety symptoms for the CBD group.
Secondary Outcome Measures
CGI-I Scores
– End of Treatment: The average CGI-I score at the end of treatment was much lower for the CBD group compared to the placebo group, with a difference of −2.31 and a p-value of <0.0001.
CGI-S Scores
– End of Treatment: The CGI-S scores showed significant improvement in the CBD group, with a difference of −1.91 and a p-value of <0.0001.
PHQ-9 Scores
– End of Treatment: The PHQ-9 scores, which measure depressive symptoms, decreased significantly in the CBD group with a difference of −6.77 and a p-value of <0.0001.
PSQI Scores
– End of Treatment: The PSQI scores, which measure sleep quality, also showed a significant reduction in the CBD group with a difference of −6.08 and a p-value of <0.0001.
Limitations and Considerations
Study Limitations
1. Sample Size and Duration: The relatively small number of participants and the short duration of the study may limit the generalizability of the results. Larger studies over longer periods are needed to confirm these findings.
2. Participant Heterogeneity: Participants had varying levels of anxiety and different comorbid conditions, which could influence the results.
3. Placebo Response: The potential for a strong placebo effect in anxiety studies was acknowledged, which could affect the perceived efficacy of the treatment. And, if the placebo effect is actually governed by the endocannabinoid system, which is still a subject of active debate, this poses an interesting question about whether the endocannabinoid system might be fighting against the impact of CBD, or perhaps augmenting it.
4. Long-Term Effects: The study did not evaluate the long-term effects of CBD treatment beyond the 15-week period.
Applicability to Different Populations
The study focused on people with mild to moderate anxiety disorders. To make these findings more applicable to a wider range of people, future research should include diverse populations with different demographic characteristics and co-morbid conditions.
Summary Thoughts
This study provides strong evidence that nanodispersible CBD oral solution is effective and safe for treating mild to moderate anxiety disorders. The significant improvements in anxiety, depression, and sleep quality highlight the therapeutic potential of CBD. These findings support further research into CBD for treating various psychiatric disorders, offering hope for a safer and more effective alternative to traditional anxiety medications.
For more information, you can access the study here: https://bit.ly/4azwHM0 OR for mainstream media coverage about the article, click here: https://bit.ly/3R0V6Dl
Read more about cannabis and mental health: here
More research on the topic here
An article about PTSD here
Here’s a look at the overlap of cannabis and anxiety from The Cannabis Handbook, Mental Health chapter, page 123-124:
Addressing Depression and Anxiety
“Depression and anxiety are two of the most common reasons why people come to me for guided cannabis therapies. Cannabis does not cure either anxiety or depression, but it offers a distraction that allows you to focus on something else besides the feelings, thoughts, and cycles of negativity. At the same time that cannabinoids turn down the volume of negative stimuli, they flush the brain with neutral and positive signals, which reduces the intensity of maladaptive thought patterns. To my mind, and in the results I see with many of my patients, these two functions allow cannabis to replace the internal wiring/signaling of pain with one of joy.
As a medication, cannabis restores the brain’s chemical equilibrium in ways similar to how antidepressants are designed to work. Antidepressants mimic brain chemicals or influence them. First, cannabis acts on the same systems of brain chemistry, making antidepressants more efficient. And like many depression, anxiety, and pain medications, cannabinoids stimulate neural growth so that the brain has stronger connectivity, enabling its natural chemical messengers to work more efficiently. In the future, we may discover that cannabis is in fact an effective treat- ment option on its own as it floods the brain with joy molecules, but as of this writing, it’s not clear. We do know that in addition to improving neural commu- nication, cannabis molecules act directly on the same receptors that bind to our naturally occurring chemistry of joy. The chemical structure of THC is similar to the brain chemical anandamide, which is our principal happiness molecule that activates and facilitates feelings of joy. The same brain circuitry that responds to anandamide responds to THC.
Most depression and anxiety medications are used in a precise, system-specific manner, operating at a single receptor or chemical pathway; very few besides can- nabis impact more than one region of the brain, or at the same time also impact regions of the body. Cannabis can also be used to address isolated components of depression and anxiety, including lethargy, fatigue, pain, aggressive or self- injurious behaviors, and others. Think about the interlocking gears of a clock and how they connect to keep the clock running. Some traditional anxiety and depres- sion medicines may replace faulty gears with a better fitting gear, or they may help existing gears run more smoothly. Cannabis doesn’t necessarily replace the gears themselves, but it extends their access in a way that still creates the desired effect. Cannabis also seems to smooth out areas of rust so that the clock continues to work well. In this way, cannabis both facilitates the interaction of all the gears to work synergistically (the whole brain) or works on just one gear.
One well-known problem with antidepressants is that the ramp-up time for these medications is very long: it can take up to six to eight weeks for anxiety and depression medications to start working. That is not the case for cannabis, where the ramp up can be as quick as two weeks to achieve a steady balance. For those suffering from acute anxiety or depression, that immediacy has tremendous value. Unlike traditional antidepressants, cannabis is not associated with weight gain, reduced sex drive, hormonal disruption (acne, mood swings), or sleep disturbances. In fact, it can improve all of these conditions, which you’ll see throughout the book.
Some medications used to treat anxiety, like benzodiazepines—Xanax, Valium, Ativan—are not only dangerous and addictive; they’re very short-acting. As satisfying as these quick-acting options are, the medications are rapidly habit forming and easily hit a level of tolerance, incurring a need for steadily increasing dose requirements. Despite the popular and misinformed rumor, cannabis is not any more addictive than caffeine. While I commonly see patients who use canna- bis regularly for improving their mental health, rarely does it interfere with the rest of their daily lives.
Using cannabis as a therapy in the presence of a healthy environment enhances your ability to improve mood, and over time, your mood may become consistently more relaxed and positive. As my patients ramp up on cannabis, they can work with their doctors to lower the amount of other depression and anxiety prescription medications—or drop them entirely.”
For More, consider picking up a copy at your local library or wherever books are sold.
References
The references for this blog are drawn from the original study published in the Asian Journal of Psychiatry and other peer-reviewed sources cited within the study. For detailed citations, please refer to the original publication and supplementary materials
Below are 10 references from the study “Evaluation of the efficacy, safety, and pharmacokinetics of nanodispersible cannabidiol oral solution (150 mg/mL) versus placebo in mild to moderate anxiety subjects- A double blind multicenter randomized clinical trial“:
- Atakan, Z., 2012. Cannabis, a complex plant: different compounds and different effects on individuals. Ther. Adv. Psychopharmacol. 2, 241–254.
- Bandelow, B., Michaelis, S., 2015. Epidemiology of anxiety disorders in the 21st century. Dialog-. Clin. Neurosci. 17, 327–335.
- Barry, M.J., Nicholson, W.K., Silverstein, M., Coker, T.R., Davidson, K.W., Davis, E.M., Donahue, K.E., Jaen, C.R., Li, L., Ogedegbe, G., Pbert, L., Rao, G., Ruiz, J.M., Stevermer, J., Tsevat, J., Underwood, S.M., Wong, J.B., US Preventive Services Task Force, 2023. Screening for anxiety disorders in adults: US preventive services task force recommendation statement. JAMA 329, 2163–2170.
- Berger, M., Li, E., Rice, S., Davey, C.G., Ratheesh, A., Adams, S., Jackson, H., Hetrick, S., Parker, A., Spelman, T., Kevin, R., McGregor, I.S., McGorry, P., Amminger, G.P., 2022. Cannabidiol for treatment-resistant anxiety disorders in young people: an open-label trial. J. Clin. Psychiatry 83.
- Blessing, E.M., Steenkamp, M.M., Manzanares, J., Marmar, C.R., 2015. Cannabidiol as a potential treatment for anxiety disorders. Neurotherapeutics 12, 825–836.
- Brody, T., 2016. Clinical trials: study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines. Academic press.
- Busner, J., Targum, S.D., 2007. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont) 4, 28–37.
- Buysse, D.J., Reynolds, C.F., 3rd, Monk, T.H., Berman, S.R., Kupfer, D.J., 1989. The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res 28, 193–213.
- Crippa, J.A., Derenusson, G.N., Ferrari, T.B., Wichert-Ana, L., Duran, F.L., Martin-Santos, R., Simoes, M.V., Bhattacharyya, S., Fusar-Poli, P., Atakan, Z., Santos Filho, A., Freitas-Ferrari, M.C., McGuire, P.K., Zuardi, A.W., Busatto, G.F., Hallak, J. E., 2011. Neural basis of anxiolytic effects of cannabidiol (CBD) in generalized social anxiety disorder: a preliminary report. J. Psychopharmacol. 25, 121–130.
- Crippa, J.A., Guimaraes, F.S., Campos, A.C., Zuardi, A.W., 2018. Translational investigation of the therapeutic potential of cannabidiol (CBD): toward a new age. Front Immunol. 9, 2009.