A clinical trial was recently launched by the Cannabis Research Institute of South Africa (CRI), in partnership with Releaf Cannabis E-Clinics, with the goal of observing how medical cannabis can help treat opioid addiction.

The duration of the trial will last for one year as it examines how cannabis affects a patient’s chronic pain. According to Business Tech, results will be provided to “relevant authorities” who can use that information to regulate medical cannabis in the country.

The trial will be led by Dr. Shiksha Gallow, who will be working with her team to conduct the study. “While the South African Health Products Regulatory Authority (SAHPRA) does not yet have any official cannabis-containing medicines approved for pain relief, anecdotal evidence and preliminary studies point towards its potential to be highly effective in pain management,” Gallow said.

Gallow explained that chronic pain is defined as lasting longer than six months. Treatments for chronic pain include opioids such as morphine, oxycodone, and codeine, which tells a patient’s opioid receptors to block pain messages sent by the body. However patients develop a tolerance over time, so the medication only works for a while, until medication doses must be increased. “Opiates are associated with many side effects, including sedation, respiratory depression—and even death,” Gallow said. “With the global increase in opiate addiction, which brings far-reaching repercussions—from ill health to broader societal issues such as crime—the research will be focused on establishing a safer alternative to treating pain.”

CRI is working with Releaf Pharmaceuticals to study cannabis and find safer medical options for patients. The company’s Managing Director, Willco Janse van Vuuren, expressed their excitement for launching this study. “At Releaf Pharmaceuticals (a proud member of the ImpiloVest Group), we believe being well is a basic human right. Social, mental and physical health is at the heart of everything that we do. We are proud to be working with Dr Shiksha Gallow and the Cannabis Research Institute of South Africa in this ground-breaking study to find natural solutions to pain management that are safe and effective,” said van Vuuren on LinkedIn.

While opioid addiction has caused the deaths of thousands of people, there is evidence that medical cannabis can help treat chronic pain without risk of addiction or overdoses. Bella Dorrington, Senior Researcher at CRI, believes that this study has a lot of potential to help people. “This study aims to emphasize the benefits of cannabis treatment. South Africa is poised to set a standard for medicinal cannabis in the world’s market as we have the resources, technology, and people to make it happen,” Dorrington said.

In June 2022, South Africa’s first clinical trial was launched by Labat Africa and its subsidiary, Biodata, who are also working with Gallow. Referred to as the “Pharma Ethics Observational Study,” this study is also analyzing how medical cannabis can help replace opioids for chronic pain. The study is working with 1,000 patients who have been taking prescribed opioids for at least three months, and are being given the cultivars Tallyman and Exodus (provided by Labat-based Sweetwaters Aquaponics). The strain called 9 Pound Hammer was also being grown for this use by Sweetwaters Aquaponics, which is known for its high THC and CBG cannabinoid percentages.

Like many places in the U.S., South African researchers are also examining how psilocybin can be used for medical treatments. In June, a study launched to investigate how the substance can help treat women with HIV and depression.

South Africa has gradually been developing as a cannabis destination. In July 2022, a township in Johannesburg (located in the semi-northern part of the country) was home to a three-day cannabis festival.

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Cannabis companies are crossing the line when they display claims such as CBD as a way to battle opioid addiction, a watchdog organization warns. Pennsylvania-based watchdog Spotlight PA looked at over 60 websites from cannabis retailers and businesses based in Pennsylvania and fact-checked the validity of health claims with health policy experts.

The report, “Unproven, unsafe” was published on February 21 and covered shortly after by the Pittsburgh Post-Gazette. 

Investigators listed several problems: “cherry-picking and misrepresenting parts of studies, making broad claims without citing any specific research, and providing incomplete information about what it takes to qualify for the state’s medical marijuana program.”

One claim was bothersome in particular: the claim that CBD can abate cravings for opioids and fight addiction. While early evidence shows that CBD could be useful in this department, medical experts say promoting these claims is dangerous.

Chelsea L. Shover, an epidemiologist and assistant professor-in-residence at the David Geffen School of Medicine at UCLA, said that promoting cannabis as an alternative for buprenorphine as an opioid use disorder treatment is “really dangerous.”

“That’s complete nonsense. If it were up to me, you wouldn’t be allowed to make claims like that,” Shover told the Pittsburgh Post-Gazette. “That’s kind of the worst-case scenario of this advertising.”

It’s also important to note that buprenorphine itself has a high risk for addiction and dependence, and causes respiratory distress and death when taken in high doses or when combined with other substances. But opioid addiction sometimes involves weaning, which CBD cannot do, under the supervision of a physician.

Among the other findings of Spotlight PA’s investigation:

• Seven websites cited a 2014 study that found U.S. medical cannabis laws were associated with lower rates of fatal opioid overdoses. But they chose not to cite a later study that showed different results. 
• Seven promoted the benefits of CBD for opioid addiction treatment, including to help with withdrawal or reduce cravings. But according to Spotlight PA, at least some of the messages go beyond the research.
• Governor Wolf’s administration says opioid use disorder should only be a qualifying condition for medical cannabis in certain circumstances, but at least 13 websites didn’t include those caveats when they described what it takes for addiction patients to qualify for cannabis.

“The findings reveal a somewhat deceptive strategy—whether intentional or not—adopted by many dispensaries and cannabis certification websites where very specific and limited scientific research is often cited to support very broad statements about cannabis’ benefits,” Stephanie Lake, a postdoctoral fellow at the UCLA Cannabis Research Initiative, wrote in an email. “The result of this strategy is an oversimplified and scientifically inaccurate message about cannabis.”

The warning serves as a reminder that individual studies are hardly conclusive—especially in the eyes of the medical community and in the eyes of authorities.

The Claim of CBD for Opioid Addiction

Early evidence suggests CBD could be used for opioid addiction, but regulators will not allow unproven medical claims to be displayed on products. A 2009 study found that CBD inhibits cue-induced heroin-seeking, but the study was limited to a rat model. A 2019 double-blind, randomized, placebo-controlled study found that CBD for the reduced cue-induced craving and anxiety in drug-abstinent individuals with Heroin Use Disorder.

Cannabis companies must abide by strict regulations such as avoiding unproven medical claims, or otherwise face the wrath of regulators such as the FDA. The FDA notes, for instance, that the CBD industry is especially overrun with cure-all claims.

That said, if you go out looking for benefits, you’ll find plenty of peer-reviewed evidence, and if you go out looking for negative effects, you’ll also find ample peer-reviewed evidence in support of those claims. The integrity of the scientific process means absorbing all reputable evidence—good or bad.

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Scientists with a new research center at the University of Washington are working on a vaccine to help fight the opioid epidemic in a bid to stem the tide of overdose deaths that has swept the nation over the past two decades. 

Marco Pravetoni, the head of the new UW Medicine Center for Medication Development for Substance Use Disorders, is leading the effort to develop the vaccine. Similar to immunization against an invading pathogen, the vaccine under development would stimulate the body’s immune system to attack and destroy opioid molecules before they can enter the brain. 

Such a vaccine would not prevent drug cravings commonly experienced by those with opioid abuse disorder. But the treatment, if successful, would block the effects of opioids including euphoria, pain relief and even overdose, thus likely reducing abuse.

The new research center opened this month and has raised more than $2 million in initial funding. Pravetoni hopes to raise enough money to complete further research on the vaccine under development.

“What I’m hoping to achieve is pretty much every year, we’re going to start a new clinical trial,” Pravetoni told the Seattle Times in early January.

An Epidemic of Opioid Overdoses

In November, provisional data from the U.S. Centers for Disease Control and Prevention showed that during the 12-month period ending April 2021, 100,306 Americans died of drug overdoses. Synthetic opioids were involved in nearly two-thirds of the overdose deaths reported.

The overdose-reversal drug naloxone has been shown to save lives in emergencies. Additionally, treatments for opioid abuse disorder including methadone and buprenorphine can help those struggling with addiction, although opioid replacement therapy drugs have their own risk of addiction. New treatments could increase the chances of success for those struggling with opioid abuse, according to Rebecca Baker, director of the National Institutes of Health’s Helping to End Addiction Long-term Initiative, a program that has helped fund Pravetoni’s research.

“(Existing medications) don’t work for everyone. And a lot of people don’t stay on them in the long term,” Baker said. “Would the outcomes be better if we had more options?”

The University of Washington’s opioid vaccine project is building on research published in the journal Nature in 1974. In that study, a rhesus monkey had been trained to self-administer heroin and cocaine. After being given an experimental vaccine to block the effects of heroin, the monkey continued to use cocaine but greatly reduced its use of heroin, suggesting the vaccine had done its job.

That study led to further research into the possibility of creating a vaccine for nicotine addiction. Although early results appeared promising, human trials showed the treatment was only as effective as a placebo. A vaccine developed to fight cocaine addiction saw a similar fate, and neither treatment received approval from the Food and Drug Administration.

Kim Janda, a chemistry and immunology professor at Scripps Research Institute in California, has spent decades researching vaccines against addictive drugs. He believes that continued research could eventually produce an effective vaccine.

“We’ve learned a lot more [about] what is possible, what’s maybe not going to be as fruitful,” Janda said, adding that vaccines may not work against all drugs of abuse. “But if there’s enough money to put behind these vaccines, and you had the infrastructure to do it, then you could move it along fairly quickly.”

This year, Pravetoni and a researcher with Columbia University have launched the first Phase 1 clinical trial of a vaccine to prevent opioid abuse. The safety and efficacy of the vaccine, which is designed to block the effects of oxycodone, is being tested in people who are already addicted but not receiving the disease.

Is an Opioid Vaccine Worth the Cost?

But human drug trials are expensive. Pravetoni estimates that bringing an effective opioid vaccine to market could cost up to $300 million. Some addiction experts, including Dr. Ryan Marino, an emergency medicine physician and medical toxicologist at Case Western Reserve University in Ohio, wonder if the money could be better spent.

“It is true that more treatment options are generally better,” Marino told Filter. “But what doesn’t make sense to me—as someone who treats both overdose and addiction—is putting so much funding towards this when we already have an antidote for opioids, a long-acting opioid blocker and two other evidence-based treatment options for opioid use disorder that both reduce opioid use and prevent overdose.”

Harm reduction activists working on the ground with people who have substance abuse disorders say that limited funds could be spent more effectively. Jessica Blanchard, the founder of Georgia a mobile harm reduction program called 229 Safer Living Access, distributes safer sex supplies and naloxone provided by other groups. But she personally covers the other costs to administer the program, which limits its operations substantially.

“With funding, not only could I afford to buy in bulk, greatly reducing cost, but I could also give participants more supplies to share with those unable to make contact with the program,” Blanchard said. “I would pay program participants to do secondary distribution. (They) are the experts here. They express a desire to participate in distributing supplies and educating their peers. But without the ability to compensate them for their time and lived-experiential knowledge, I simply can not ask them to help.”

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Only a few weeks after opening, supervised injection sites in New York City have potentially saved dozens of lives, leading city leaders to call on the Biden administration to authorize the use of similar harm reduction programs nationwide.

New York Mayor Bill de Blasio and the city’s health department announced on November 30 that the nation’s first publicly recognized overdose prevention centers (OPCs) had commenced operations in the city. Also commonly known as supervised injection sites, OPCs offer people a safe place to consume illicit drugs under the supervision of staff trained to intervene in the event of an overdose.

Other services including clean needle exchange, HIV testing and referrals to addiction treatment programs are often commonly available at supervised injection sites.

De Blasio, who has been calling for an OPC pilot program since 2018, noted that more than 2,000 people died of a drug overdose in New York City in 2020, the highest number since reporting began in 2000. Nationwide, more than 90,000 people died of an overdose in 2020, according to the Centers for Disease Control and Prevention, the worst year ever recorded.

Supervised Injection Sites Save Lives

Internationally, supervised injection sites have been saving lives for decades. Research over 30 years at more than 100 such facilities has proven the efficacy of such programs. No overdose deaths have ever been recorded at a supervised injection site, and research has also shown that the sites reduce public drug use, litter from syringes and drug-related crime in surrounding neighborhoods.

“After exhaustive study, we know the right path forward to protect the most vulnerable people in our city, and we will not hesitate to take it,” de Blasio said in a statement at the time. “Overdose Prevention Centers are a safe and effective way to address the opioid crisis. I’m proud to show cities in this country that after decades of failure, a smarter approach is possible.”

Council Member Mark Levine, chair of the City Council Health Committee, said that “NYC has taken historic action against the mounting crisis of opioid deaths with the opening of the nation’s first overdose prevention centers.”

“This strategy is proven to save lives, and is desperately needed at a moment when fatalities are rising fast,” Levine added. “I applaud the city as well as the providers who offer these lifesaving services for this bold approach to stopping this crisis.”

The city’s OPCs are operated by outreach and education group New York Harm Reduction Educators, which has opened two supervised injection sites at existing facilities in Harlem and Washington Heights. As of December 14, only two weeks into the program, the two sites had registered 350 participants and staff had already reversed 43 overdoses, according to a report from WNYC/Gothamist.

City Leaders Seek Support from Biden Administration

The success of New York’s OPCs has led a group of city leaders to call on the administration of President Joe Biden to support federal authorization of supervised injection sites nationwide. Under the federal Controlled Substances Act, it is illegal to operate, own or rent a location for the purpose of using illegal drugs. 

In an op-ed published on December 15, New York City Health Commissioner Dr. Dave A. Chokshi, Bronx District Attorney Darcel Clark, Brooklyn District Attorney Eric Gonzalez, Queens District Attorney Melinda Katz and Manhattan District Attorney Cy Vance called on Biden to provide legal protection for OPCs to open across the country. 

They noted that in April, New York had joined the cities of San Francisco, Oakland, Philadelphia, Pittsburgh and Somerville, Massachusetts, in a letter to Attorney General Merrick Garland, asking the Justice Department to deprioritize enforcement of federal drug laws against supervised injection sites. But so far, no response has been received from federal officials.

The civic leaders also noted that Biden had recently become the first president to include harm reduction in his drug policy priorities and said that New York’s OPCs could be a model for the nation. Under the American Rescue Plan passed by Congress in March, $30 million was appropriated to state, local and tribal governments and organizations for overdose prevention and harm reduction services.

“It is time to embrace bold strategies in the face of public health crises, even if they may seem radical at first,” they wrote in the BuzzFeed News op-ed. “Thirty years ago, in the midst of the HIV/AIDS epidemic, New York City activists started one of the first syringe service programs in the country and, as a result, reduced HIV transmission among people who inject drugs, averting countless deaths.”

“We urge the Biden administration to endorse overdose prevention centers, empowering state and local jurisdictions to fully leverage their resources and authority to build healthier and safer cities, towns and communities,” the civic leaders concluded.

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A federal jury in Ohio on Tuesday found that pharmacy giants Walgreens, CVS and Walmart contributed to the opioid crisis in that state, a verdict that could serve as a bellwether for thousands of similar cases pending from coast to coast. The decision is the first verdict returned by a jury that holds a pharmacy retailer responsible for its role in the devastating epidemic of opioid overdoses that has plagued the United States for decades.

In the lawsuit, Lake and Trumbell Counties in northeastern Ohio maintained that the pharmacy retailers had recklessly distributed more than 100 million opioid pain pills in the counties, leading to addiction, death and a strain on public services. Between 2012 and 2016, more than 80 million prescriptions painkillers were dispensed in Trumbull County alone, or about 400 pills for every resident. During the same period, approximately 61 million opioid painkillers were dispensed in Lake County.

“For decades, pharmacy chains have watched as the pills flowing out of their doors cause harm and failed to take action as required by law,” a committee of attorneys representing local governments in federal opioid lawsuits said in a statement. “Instead, these companies responded by opening up more locations, flooding communities with pills, and facilitating the flow of opioids into an illegal, secondary market.”

Counties Say Pharmacies Created a Public Nuisance

Attorneys for the plaintiffs argued that the actions of the pharmacies amounted to a public nuisance that cost the counties about $1 billion each to address. Mark Lanier, an attorney representing the counties, said that the pharmacies failed to hire or train enough employees and implement systems to prevent suspicious orders from being filled.

“The law requires pharmacies to be diligent in dealing drugs,” Lanier said. “This case should be a wake-up call that failure will not be accepted.” 

“The jury sounded a bell that should be heard through all pharmacies in America,” he added.

The suit originally also named pharmacy retailers Rite-Aid and Giant Eagle as plaintiffs in the case. Rite-Aid settled in August and agreed to pay Trumbull County $1.5 million in damages, while a settlement amount with Lake County has not been released. Giant Eagle agreed to settle late last month, although terms of that agreement were not disclosed.

The case, which was decided by a 12-person jury after a six-week trial, was returned in one of about 3,000 federal opioid lawsuits being supervised by U.S. District Judge Dan Polster in Cleveland. Adam Zimmerman, who teaches mass litigation at Loyola Law School in Los Angeles, said that the verdict could prompt other pharmaceutical retailers to settle their pending cases.

“It’s the first opioid trial against these major household names,” Zimmerman told the New York Times. “They have been the least willing group of defendants to settle, so this verdict is at least a small sign to them that these cases won’t necessarily play out well in front of juries.”

Pharmacy Chains Will Appeal Verdict

All three retailers have indicated that they will appeal the jury’s verdict. Walmart said in a statement that the plaintiffs’ attorneys sued “in search of deep pockets while ignoring the real causes of the opioid crisis—such as pill mill doctors, illegal drugs, and regulators asleep at the switch—and they wrongly claimed pharmacists must second-guess doctors in a way the law never intended and many federal and state health regulators say interferes with the doctor-patient relationship.”

Walgreens spokesperson Fraser Engerman characterized the case as an unsustainable effort “to resolve the opioid crisis with an unprecedented expansion of public nuisance law,” adding that the company “never manufactured or marketed opioids nor did we distribute them to the ‘pill mills’ and internet pharmacies that fueled this crisis.”

“As plaintiffs’ own experts testified, many factors have contributed to the opioid abuse issue, and solving this problem will require involvement from all stakeholders in our health care system and all members of our community,” CVS spokesperson Mike DeAngelis said in a statement after the verdict was announced.

The retail pharmacies are not alone in their criticism of the verdict. Dr. Ryan Marino, an assistant professor of the Departments of Emergency Medicine and Psychiatry at Cleveland’s Case Western Reserve University School of Medicine, says that focusing on blaming the pharmaceutical industry, prescribers, and pharmacies ignores the role that bad policies have played in the opioid crisis.

“If retail pharmacies are declared responsible, I ask that we also hold policymakers responsible for their role in driving people to foreseeable death and failing to act to prevent disordered substance use or addiction by failing to provide access to safety in addition to basic things like housing, education, employment, and income, which are well known to prevent addiction in the first place,” Marino wrote in an email to High Times. “The same old approaches have not helped this problem, and in fact, seem to be only making it worse.”

Some drug manufacturers and distributors including Johnson & Johnson have also opted to settle cases brought against them for their alleged contributions to the opioid crisis, which has killed more than 500,000 Americans over the past twenty years. Kevin Roy, chief public policy officer at addiction solutions advocacy group Shatterproof, said that Tuesday’s verdict could prompt other pharmacies to consider a settlement.

“It’s a signal that the public, at least in select places, feels that there’s been exposure and needs to be remedied,” Roy said.

Roy noted, however, that the different courts hearing opioid cases have not been consistent in their judgments and that the details of public nuisance laws vary from state to state. Earlier this month, a California judge ruled in favor of drug manufacturers in a case brought by the city of Oakland and three counties. And in Oklahoma on November 9, the state Supreme Court overturned a 2019 verdict for $465 million against Johnson & Johnson.

“There’s been a variety of different decisions lately that should give us reason to be cautious about what this really means in the grand scheme,” Roy said.

Just how much Walgreens, CVS and Walmart will have to pay Trumbull and Lake Counties remains to be seen. The judge is expected to issue a decision on damages to be awarded in the case in the spring.

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More than 100,000 people succumbed to overdose deaths in the United States in the span of a year, a record death toll that underscores the continuing failure of the War on Drugs to keep the nation safe.

During the 12-month period ending April 2021, 100,306 Americans died of drug overdoses, according to provisional data released by the U.S. Centers for Disease Control and Prevention on Wednesday. Federal officials point to the coronavirus pandemic and the proliferation of powerful synthetic opioids including fentanyl as major contributors to the spike in overdose deaths over the past two years.

“These are numbers we have never seen before,” Dr. Nora Volkow, director of the National Institute on Drug Abuse, told the New York Times. Commenting on the human toll behind the statistics, Volkow noted that a majority of the deaths occurred among people aged 25 to 55.

“They leave behind friends, family and children, if they have children, so there are a lot of downstream consequences,” Dr. Volkow said. “This is a major challenge to our society.”

Overdose Deaths Add to Covid-19’s Toll

During the same time period, approximately 509,000 died from Covid-19 in the United States, according to figures from Johns Hopkins University, while millions were left isolated due to quarantines and business closures. Volkow noted that the pandemic also led to border shutdowns that made powerful synthetic opioids including fentanyl easier to smuggle into the country than naturally produced but less potent and thus more bulky drugs including morphine and heroin.

“What we’re seeing are the effects of these patterns of crisis and the appearance of more dangerous drugs at much lower prices,” Volkow said to CNN. “In a crisis of this magnitude, those already taking drugs may take higher amounts and those in recovery may relapse. It’s a phenomenon we’ve seen and perhaps could have predicted.”

The new data, representing deaths from May 2020 through April 2021, reflects a 28.5 percent increase in the number of fatal overdoses in the United States compared to the same time period one year earlier and the first time deaths have exceeded 100,000 in one year. Synthetic opioids including fentanyl were up 49 percent over the year before, contributing to the vast majority (64 percent) of overdose deaths. Stimulants including methamphetamines were involved in about a quarter of overdose deaths, a jump of 48 percent over the previous year. The data also show more modest increases in the number of overdose deaths caused by natural opioids, cocaine and prescription medications.

Dr. Volkow said that while some drug users intentionally seek out fentanyl, others “may not have wanted to take it. But that is what is being sold, and the risk of overdose is very high.”

The pandemic also decreased the availability and access to treatment for substance use disorders. As the country reopens and life begins to return to normal, overdose deaths are likely to remain high if access to drug treatment and other interventions is not improved, experts says.

“Even if Covid went away tomorrow, we’d still have a problem. What will have an impact is dramatic improvement to access to treatment,” said Dr. Andrew Kolodny, medical director of opioid policy research at the Brandeis University Heller School for Social Policy and Management.

“These are deaths in people with a preventable, treatable condition. The United States continues to fail on both fronts, both on preventing opioid addiction and treating addiction,” he continued, adding that President Joe Biden should act on his campaign promises to address the continuing opioid crisis.

Access to Treatment Saves Lives

The White House Office of National Drug Control Policy on Wednesday released model legislation to serve as a guideline for states to pass laws that increase access to naloxone, a life-saving drug that can reverse opioid overdoses. Other medications including buprenorphine can be prescribed to help those with opioid use disorder, but access to the drugs is also often limited. In October, the U.S. Department of Health and Human Services issued a plan to combat drug overdoses, including federal support for harm reduction and recovery services and provisions that lessen barriers to substance abuse treatment.

“If we really want to turn the corner, we have to get to a point where treatment for opioid addiction is easier to access than fentanyl, heroin, or prescription opioids are,” Kolodny said.

Beth Connolly, director of the Pew Charitable Trusts substance use prevention and treatment initiative, said that improving access to drug treatment and emergency interventions can help bring down the spike in overdose deaths.

“The evidence is really clear that using medications to treat opioid addiction disorders saves lives,” said Connolly. “As we see more and more evidence that (medication) does save lives, that will hopefully reduce stigmatizing and categorizing in favor of supporting individuals.”

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