Can Psilocybin Help Smokers Quit? This Clinical Trial Aims to Find Out

Psilocybin – the primary active ingredient in magic mushrooms – is to be studied in a new clinical trial that will test whether the psychedelic compound can help people quit smoking.

Mydecine Innovations Group, a biopharmaceutical company that specializes in psychedelic therapeutics for mental health and addiction treatment, has announced its partnership with the renowned psychedelic science researcher Dr Matthew Johnson of Johns Hopkins University to carry out a clinical trial on Mydecine’s purified psilocybin drug MYCO-001 in a structured smoking cessation treatment program.

The study will also aim to develop new methodologies that should help to advance future clinical trial procedures when dealing with psychedelic medicines.

Seamless phase two/three trial expects results as early as next winter

The planned placebo-controlled study will be based within the Johns Hopkins psychedelic research group led by Dr Johnson and shall look to study the efficacy of MYCO-001 in smoking cessation and the scientific mechanisms behind this effect.

The study will take the form of a phase two/three clinical trial, meaning that it will utilize the results acquired at earlier stages of the study to tweak and adjust the course of the study as more data is collected. This data analysis and adjustment can be performed at predetermined time points throughout the study timeline, allowing the researchers to flexibly alter treatment dosages, treatment direction, or the study endpoints in light of new information as it appears.

“The really exciting thing about this trial is the succinctness of the outcomes; the patients in the trial are either quitting smoking or not. We [will] have survey data on that as well as carbon monoxide blood readings, [so] we really have a definitive way of tracking whether they’re quitting versus not,” Rob Roscow, chief scientific officer and co-founder of Mydecine, told Analytical Cannabis.

"Because the treatments that we’re comparing against are so ineffective, the time course to show a statistically better outcome is actually significantly shorter than some of the other indications that others in the space are running clinical trials on. If you stack all those factors together, we have an easily demonstrable result and a relatively short calendar to actually run the trial, which gives us an avenue to having the first if not one of the first prescribable psilocybin drugs on the market. We’re really excited about that.”

The team is expecting the planned study to commence in the first quarter of 2022 and will have primary endpoints of three and six months. Given the fairly binary nature of smoking cessation and the relatively low success rates of smoking cessation therapies that do not rely on tobacco replacement, the team anticipates that the seamless trial could be completed by the end of 2022.

Psilocybin for smoking cessation

Smoking is the leading cause of preventable death in the United States, according to the Centers for Disease Control and Prevention (CDC). Worldwide, tobacco use is linked to more than 7 million deaths per year and 480,000 deaths per year in the United States alone. Exposure to second-hand smoke is also thought to cause more than 41,000 deaths annually.

“If you look at it, it’s not smoking directly but it’s the cancer [risk], the cardiovascular disease that smoking causes [that is of concern],” said Robscow. “We feel that this is one of the largest outstanding negative health behaviors and habits that’s out there.”

According to CDC figures, more than half of smokers report making an attempt to quit within the last three months, but less than 10 percent actually succeed. Additionally, one of the most successful smoking cessation treatments – varenicline, also known by the brand name Chantix – was recalled in July 2021. While other pharmacological and tobacco-replacement therapies do exist, tobacco addiction still remains largely untreated.

Psilocybin has been being investigated as a potential smoking cessation aid for several years. In 2014, a psilocybin-facilitated smoking cessation study from Dr Johnson and colleagues at Johns Hopkins University showed an 80 percent abstinence rate six months after receiving a course of psilocybin-assisted therapy, falling only marginally to 60 percent after 12 months. Johns Hopkins researchers are currently working on another clinical trial comparing the efficacies of transdermal nicotine patches with cognitive therapy treatment versus psilocybin with cognitive therapy, with the early results showing good promise for psilocybin treatment.

“It’s the behavioral addiction that’s really being addressed,” said Robscow. “That’s why we see with smoking specifically such strong efficacy months and years out in a timeframe and why that’s so different compared to using a patch, [going] cold turkey, or Chantix type quitting regimes.”

“It’s really because the psilocybin, plus the therapy that’s being paired with it, is acting to reset people’s mental behaviors and habits and thought patterns around their addictive substance or behavior of choice; whereas the traditional therapies are really only dealing with cravings, with physical withdrawal symptoms, these sorts of things,” he added.

This article was originally published on Analytical Cannabis, Technology Networks'  sister publication.