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FDA Approves Trial To Treat Opioid Addiction With CBD

January 6, 2023 /Posted by

Opioid use disorder (OUD) is currently affecting the United States of America. Currently, there is not much out there to effectively combat the widespread effects of opioid use disorder, but there may be hope within the supplement industry. You may have heard of cannabidiol, also known as CBD, and its potentially amazing benefits. In recent years, the FDA approved CBD for the treatment of rare childhood forms of epilepsy [1]. Now, the FDA has approved a human trial to test the use of CBD as a potential treatment for opioid addiction [2].

 

CBD Has Received a Green Light

In January 2022, ANANDA Scientific, a biotech pharmaceutical company, received exceptional news: the proposal for a clinical trial utilizing CBD in the form of a prototype drug called Nantheia ATL5 was approved. The US Food and Drug Administration had previously approved an Investigational New Drug (IND) for the trial which is to be performed at the Icahn School of Medicine at Mount Sinai, a part of UCLA.

The study will be conducted as a randomized, placebo-controlled, double-blind, sequential, and dose-ranging study using either 600 or 1,200 mg of CBD per day [3]. Patients will also be given buprenorphine and naloxone, as well as behavioral therapy. The first phase of the clinical trial is to test the tolerability and safety of CBD. Secondary measures will include measurements on the reduction of cravings, negative affective states, and relapse.

Interestingly, Nantheia ATL5 is also being used in a study for the treatment of PTSD [4]. The clinical study was first posted in March 2022 and is currently in the planning phase. Recruitment has yet to begin for either clinical study. However, in July 2022, ANANDA Scientific announced the recruitment of their first patient for the opioid addiction trial.

 

What is Nantheia ATL5?

The investigational drug in question is, as mentioned earlier, named Nantheia ATL5. Made with ANANDA’s Liquid Structure technology and is designed to enhance the effectiveness of cannabidiol within the system [5]. The idea is that, by introducing CBD, those suffering from OUD will have a better chance at reducing their intake and cravings for opioids.

Nantheia ATL5 comes as a soft gel capsule containing 100 mg of CBD.

 

Why Is This Potential Treatment So Pivotal?

2021 was the first time in history that overdose deaths topped 100,000 in the US [6]. Opioids accounted for 75% of those overdose fatalities, sadly proving that drug addiction and overdose is running rampant in the nation. Because of that, researchers want to leave leads left unattended when it comes to curing this widespread issue. They want to find a gentle yet effective solution to OUD.

Presently, the FDA has approved only buprenorphine, naltrexone, and methadone as medication-assisted treatments (MATs) for opioid use disorder. However, because each of these MATs comes with a high risk of side effects and other issues, it has left researchers wondering if there was a better way.

Being that CBD has the potential to be a non-toxic option for managing certain conditions, scientists have considered it as a supplemental treatment for OUD [7].

 

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Does Other Research Support Using CBD for Opioid Addiction?

Although the amount of research conducted on the effects of cannabidiol on substance use disorder (SUD) and opioid use disorder, the evidence that is out there is mainly positive.

For example, in 2019, researchers from Mount Sinai conducted a human trial to see how well CBD affected heroin cravings [8]. 42 participants were either assigned 400 or 800 mg of CBD or a placebo and then were exposed to certain cues at three specific times—after administration of the CBD or placebo, 24 hours after administration, and seven days later. The researchers found that those participants who received CBD had significant reductions in anxiety and cravings induced by drug-related and neutral cues. Furthermore, CBD reduced certain physiological responses, such as increased heart rate and salivation.

A review from 2021 found that CBD, when used alone or with a combination of treatment strategies, was potentially therapeutic and may be used in the dishabituation of those with SUDs, including alcohol, tobacco, and cannabis [9].

Another review from October 2022 looked at 41 scientific research articles on CBD and opioid withdrawal [10]. The researchers found that CBD may have therapeutic properties, including anxiolytic, anti-inflammatory, antidepressant, analgesic, anti-emetic, and craving reduction. Furthermore, the scientists noted that “CBD has been shown in several clinical trials to be well-tolerated with no significant adverse effects, even when co-administered with a potent opioid agonist.” In other words, CBD was well tolerated among the participants of the reviewed clinical trials.

 

Ready to Try CBD For Yourself?

ANANDA Scientific is currently a front-runner when it comes to developing a medication for opioid use disorder that utilizes CBD. Already, many studies have shown that CBD may reduce cravings and help with anxiety related to withdrawal. Now it is time to see if Nantheia ATL5 will have any effect. If it does, another CBD-derived medication may be approved by the FDA. Hopefully, the clinical trials will be underway soon.

Until then, there is no reason not to try CBD for yourself. Sugar Bottom Hemp has a wide variety of CBD products, including tinctures and edibles. Our CBD is sourced from organic hemp and minimally processed. We also send our CBD to an independent third-party lab for a full analysis, ensuring you get the purest CBD possible. You are bound to find something you will love, so check out our full catalog today!

Want to know more about us or our products? Feel free to send us a message.

 

Sugar Bottom Hemp

 

Bibliography

1. Office of the Commissioner. (2018, June 26). FDA Approves First Drug Comprised of an Active Ingredient Derived from Marijuana to Treat Rare, Severe Forms of Epilepsy. U.S. Food And Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms

2. ANANDA Scientific Announces FDA approval of the IND for the Clinical Trial on the Treatment of Opioid Use Disorder (OUD). (2022, January 4). Business Wire. https://www.businesswire.com/news/home/20220104005104/en/ANANDA-Scientific-Announces-FDA-approval-of-the-IND-for-the-Clinical-Trial-on-the-Treatment-of-Opioid-Use-Disorder-OUD

3. Ananda Scientific Inc. (2022, July 26). ANANDA Scientific Announces First Patient Enrolled in the Clinical Trial on the Treatment of Opioid Use Disorder (OUD). https://www.newswire.ca/news-releases/ananda-scientific-announces-first-patient-enrolled-in-the-clinical-trial-on-the-treatment-of-opioid-use-disorder-oud–883951652.html

4. University of Nebraska, & Rizzo, M. (2022, November 2). Safety and Efficacy of Cannabidiol (CBD) for Symptoms of PTSD in Adults. ClinicalTrials.gov. Retrieved December 12, 2022, from https://beta.clinicaltrials.gov/study/NCT05269459

5. ANANDA Scientific’s Liquid StructureTM Cannabidiol (CBD) to Be Clinically Evaluated for Opioid Use Disorder. (2021, October 19). Business Wire. https://www.businesswire.com/news/home/20211019005004/en/ANANDA-Scientific%E2%80%99s-Liquid-Structure%E2%84%A2-Cannabidiol-CBD-to-Be-Clinically-Evaluated-for-Opioid-Use-Disorder

6. Langendorf, J. (2022, February 21). Fentanyl, COVID Push Overdose Deaths to 100,000. Treatment Magazine. https://treatmentmagazine.com/fentanyl-covid-push-overdose-deaths-to-100000/

7. Machado Bergamaschi, M., Helena Costa Queiroz, R., Waldo Zuardi, A., & Alexandre S. Crippa, J. (2011). Safety and Side Effects of Cannabidiol, a Cannabis sativa Constituent. Current Drug Safety, 6(4), 237–249. https://doi.org/10.2174/157488611798280924

8. Hurd, Y. L., Spriggs, S., Alishayev, J., Winkel, G., Gurgov, K., Kudrich, C., Oprescu, A. M., & Salsitz, E. (2019). Cannabidiol for the Reduction of Cue-Induced Craving and Anxiety in Drug-Abstinent Individuals With Heroin Use Disorder: A Double-Blind Randomized Placebo-Controlled Trial. American Journal of Psychiatry, 176(11), 911–922. https://doi.org/10.1176/appi.ajp.2019.18101191

9. Navarrete, F., García-Gutiérrez, M. S., Gasparyan, A., Austrich-Olivares, A., & Manzanares, J. (2021). Role of Cannabidiol in the Therapeutic Intervention for Substance Use Disorders. Frontiers in Pharmacology, 12. https://doi.org/10.3389/fphar.2021.626010

10. Kudrich, C., Hurd, Y. L., Salsitz, E., & Wang, A. L. (2022). Adjunctive Management of Opioid Withdrawal with the Nonopioid Medication Cannabidiol. Cannabis and Cannabinoid Research, 7(5), 569–581. https://doi.org/10.1089/can.2021.0089

 

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We are a collection of local farmers and business people who were brought together over our love of the hemp plant and the many health benefits we’ve received by using CBD in its various forms. We strive to be a leader in our community as an example of innovative farming and healthy living.

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