Monthly Archives: May 2022

For years, US cannabis executives have protested a law that they say is obscure and outdated, and that makes it hard for them to turn a profit.

The law, a section of the federal tax code known as 280E, could now hamper psychedelics companies that want to enter the first state market for magic mushrooms in the US, similarly to how it affects cannabis firms.

Congress passed 280E to aid President Ronald Reagan's war on drugs. The law prohibits companies that illegally sell Schedule I and Schedule II drugs from deducting regular business expenses like office supplies or health-insurance premiums. Effectively, those companies have to pay more in taxes. Because cannabis and psilocybin are federally illegal, 280E affects businesses even in areas where the substances are locally legal.

Psychedelics companies haven't had to contend with the tax-related hassles associated with 280E because they've focused on pharmaceutical research and development or conducted their business in countries where the drugs aren't federally prohibited.

But now, as Oregon prepares to create the first legal-psychedelics market in the US, many psychedelics companies will have to grapple with the complicated tax implications for the first time.

According to Harris Bricken, an international law firm, psilocybin businesses in Oregon could face challenges like those that cannabis companies faced. Because psilocybin is illegal under federal law, it will likely be difficult for the companies to find banks or credit unions to work with them. It also makes securing funding more difficult.

Sam Chapman, the executive director for the Healing Advocacy Fund, a nonprofit focused on the implementation of Oregon's psilocybin program, told Insider that he expects the 280E tax issue to catch a lot of operators by surprise.

"There's still a pretty big cloud around how to successfully manage a 280E tax liability," he said.

Dina Burkitbayeva, a cofounder of Psymed Ventures, a psychedelics-focused venture-capital firm, said 280E would make doing business extremely challenging for a lot of the companies in Oregon, therefore making it difficult for investors like herself to deploy capital in the state.

"You're really not running a very sexy business," she said. "We're excited that these efforts are happening in Oregon, but from a venture-investment standpoint, we're not really seeing a lot of opportunity."

Mason Marks, an attorney who was the chair of the licensing subcommittee for Oregon's Psilocybin Advisory Board, said he expects 280E to affect most, if not all, of the psychedelics companies looking to operate in Oregon. He added that bigger businesses able to scale would have an advantage.

"Those are the ones that are going to be the most profitable, because the tax situation is really eating into your profits," Marks said. "You need to operate at a certain scale that keeps your overhead down."

Marks said operators from the cannabis industry would also have an edge because they've dealt with the same law.

It's still unclear which companies in Oregon 280E would directly affect. While cultivators who grow the mushrooms would undeniably be subject to the law, it likely would not affect data companies and other ancillary businesses.

Startups focused on training practitioners may also be exempt, though that may depend on whether the state's training criteria require training firms to supply psilocybin to trainees.

Elana Tamas, a tax advisor at the New York accounting advisory firm Anchin who has helped cannabis companies navigate 280E for years, said companies working with cannabis or psilocybin could restructure to limit the harm of 280E.

If a psychedelics-retreat firm, for example, can prove that its psilocybin-administering operation is separate from the retreat operation, it would be able to file separate taxes for those two entities. In this case, only the company that administers psilocybin would face elevated taxes.

"It's an analysis that you have to make based on what the economic realities are, so it's not something that you can just say and create. It's something that really needs to be economically true," Tamas said. "There really needs to be a really strong paper trail to support the differentiation between the expenses relating to one business and the income relating to one business."

Excerpt from:

Psychedelics Companies in Oregon Will Have to Grapple With 280E - Business Insider

Welcome to TDRs review of the Top 5 Psychedelic developments for the week of May 9. Aside from presenting a synopsis of events, we provide market commentary to summarize the week that was for publicly-listed companies.

5. Biden Administration Announces $1.5 Billion Funding Opportunity for State Opioid Response Grant Program

The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), is announcing a State Opioid Response (SOR) grant funding opportunity that will provide nearly $1.5 billion to states and territories to help address the Nations opioid addiction and overdose epidemic. In President Bidens State of the Union, he named beating the opioids epidemic as a pillar of his Unity Agenda. Todays announcement is a critical step forward in that work, and the SOR program, along with theTribal Opioid Responsegrant funding opportunity announced recently, are critical tools in President Bidens inaugural National Drug Control Strategy released last month and the Health and Human Services (HHS)Overdose Prevention Strategy.

The State Opioid Response grant program delivers crucial aid to states and territories to help address in the crisis of overdose and death in our nations communities, said HHS Secretary Xavier Becerra. And, in line with HHS Overdose Prevention Strategy, this funding helps facilitate state- and territory-level efforts to ensure the full continuum of prevention, harm reduction, treatment and long-term recovery supports are in place and accessible to all who need them.

TheSOR grant programprovides formula funding to states and territories for increasing access to FDA-approved medications for the treatment of Opioid Use Disorder (OUD), and for supporting prevention, harm reduction, treatment, and recovery support services for OUD and other concurrent substance use disorders (SUD). The SOR program also supports care for stimulant misuse and use disorders, including for cocaine and methamphetamine. The SOR program helps reduce overdose deaths and close the gap in treatment needs across America by giving states and territories flexibility in funding evidence-based practices and supports across different settings to meet local community needs.

4. Awakn Life Sciences Completes Worlds First Ketamine Treatment Study for a Range of Behavioral Addictions

Awakn Life Sciences Corp.(NEO: AWKN)(OTCMKTS:AWKNF) announced today the completion of the worlds first ketamine treatment study for behavioral addictions. The behavioral addictions included in the study were Gambling Disorder, Internet Gaming Disorder, Binge Eating Disorder and Compulsive Sexual Behavior.

Results from Awakn's #ketamine treatment study for behavioral #addictions indicate the desired effects via potentially novel mechanisms and these results merit a larger study and further exploration, which Awakn is now initiating. Learn more: https://t.co/7DW4Tu3RCF $AWKN $AWKNF

The study was led by Prof. Celia Morgan, Awakns Head of Ketamine-Assisted Therapy, Professor of Psychopharmacology at the University of Exeter, U.K., and an internationally respected expert in the therapeutic use of ketamine. The study investigated ketamine as a new treatment approach for these behavioral addictions by opening a window in which the brain can make new connections to change behavior.

The results from the study indicate the desired effects via potentially novel mechanisms and these results merit a larger study and further exploration, which Awakn is now initiating. The study also supports Awakns Intellectual Property (IP) strategy and existing filed patent applications, positioning Awakn as a leading company in the behavioral-addiction therapeutic research and development industry. The company expects to update investors further on its IP strategy in the coming weeks.

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Antidepressants And Psychedelics Drug Interaction Chart

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3. Big Rebound As Psychedelic Stocks Outperform BioPharma Indexes

The biggest psychedelic stocks mostly rose this past week, noticeable outperforming peer biopharma indexes. TheHorizon Psychedelic Stock Index ETF(PSYK) climbed12.80%, which was materially stronger than both theNasdaq Junior Biotechnology Index(2.42%) andNasdaq Biotechnology Ishares ETF(2.18%). This occurred despite broad markets which slumped for a seventh consecutive weekNASDAQ1004.40%andS&P 5002.93%. This was the seventh consecutive week of decline in both of these indexes, which hasnt occurred since the Great Financial Crisis of 2008. Heres how the Health Care (Biotechnology) sector performed:

Weekly technical snapshot, PSYK ETF:

In the news

atai Life Sciences reported financial results for the quarter ended March 31, 2022 and provided a business update. Ended the first quarter with $335 million cash, maintaining atais position as a well-funded, leading mental health company.

TDRs Take: Atai Life Sciences: Optimizing Drug Development By Avoiding Big Pharmas Past Missteps

Australias national science agency CSIRO is aiming to develop new psychedelics for a variety of mental health conditions including depression, addiction, end-of-life anxiety and PTSD.

Awakn Life Sciences announced that Dr. ArunDhandayudham is joining Awakn as its Chief Medical Officer. Dr. Ben Sessa is stepping back from his role as CMO to become Awakns Head of Psychedelic Medicine, allowing him to continue his work in research, academic and training activities, as well as a greater focus on the day-to-day treatment of his clients as the Lead Physiatrist for Awakn Clinics Bristol.

Braxia Scientific receives Special Access Program (SAP) approval for use of psilocybin inOntario. Health Canada approval is for patients with Major Depressive Disorder in the absence of terminal medical illness or end of life distress.

CB Therapeutics has been granted a new patent covering the use of microorganisms to produce tryptamines and their analogs, such as psilocybin and various other molecules found in magic mushrooms.

Clearmind Medicine announced positive safety results of its proprietary molecule, MEAI, to treat alcohol abuse.

Clerkenwell Health opening Europes first commercial psychedelic research facility.

Davos 2022: The first ever medical psychedelics series will be hosted by Energia Holdings Incorporated. The worlds most prominent psychedelic industry leaders, drug development experts, clinicians, nonprofit organizations, advocates, and influencers will gather separately inDavosat the inauguralMedical Psychedelic Seriesto help shape the future of mental health.

Havn Life Sciences announced a partnership withTheraPsil a non-profit coalition dedicated to helping Canadians in medical need access legal psilocybin-assisted psychotherapy and GMP-quality psilocybin. Under the Partnership, TheraPsil will support prescribing healthcare professionals in requesting psilocybin from HAVN Life, and other licensed dealers enrolled in TheraPsils Project Solace, through the Special Access Program. TDR interviews CEO Tim Moore:

Mind Medicine announced that the registration statement on Form S-3, filed onMay 4, 2022, was declared effective by the U.S. Securities and Exchange Commission, which includes a prospectus for an at-the-market equity offering under which the company may offer and sell its Subordinate Voting Shares or common shares re-designated from the Companys Subordinate Voting Shares for up to$100,000,000in aggregate sales proceeds.

Nirvana Life Sciences announced the appointment of Mr. Jakson Inwentash to the companys Board of Directors.

Optimi Health has completed the acquisition of a diverse catalog of psilocybin and functional mushroom strains intended for cultivation in its 20,000 square foot, EU-GMP compliant facility in Princeton, British Columbia.

Red Light Holland has completed the third export of psilocybe truffles, from the Netherlands to Canada, under a Health Canada psilocybin import permit awarded to CCrest Laboratories Inc. in partnership with Shaman Pharma Corp.

Silo Pharma announced that it in conjunction with the University of California San Francisco (UCSF), researchers have successfully dosed patients suffering from Parkinsons disease. As part of this study, the researchers are collecting blood samples to determine the effects of psilocybin on inflammatory markers of patients who have exhibited signs of Parkinsons.

2. MindMed Reports Topline Data From Phase 1 Trial of MM-110 in Development for the Treatment of Opioid Withdrawal

Mind Medicine (NASDAQ: MNMD), (NEO: MMED) announced topline results from the Phase 1 placebo-controlled trial designed to assess the safety, tolerability, pharmacokinetics and neurocognitive effects of MM-110 in 108 healthy volunteers. The results showed favorable safety and tolerability, support the advancement of MM-110, and have guided the Phase 2a dose, schedule, and design in individuals undergoing supervised opioid withdrawal. MM-110 (also known as zolunicant HCl or 18-MC) is an 34 nicotinic cholinergic receptor antagonist and non-hallucinogenic proprietary congener of ibogaine.

MindMed today announced topline results from the Phase 1 trial of MM-110. The results showed favorable safety and tolerability, and have guided the Phase 2a trial design in individuals undergoing supervised opioid withdrawal. https://t.co/ax7DSiDT1Q

A total of 72 participants received up to 325 mg of MM-110 (n=51) twice on a single day or placebo (n=21), and 36 participants were administered up to 90mg of MM-110 (n=26) twice daily for seven days or placebo (n=10). The topline results and observations include the following:

1. First Patient In Quebec Gets Approval From Health Canada For Magic Mushroom Therapy

In Montreal, meanwhile, a pioneering clinic in the emerging field of psychedelic-assisted psychotherapy is about to become the first health-care facility in Quebec to legally treat depression with psilocybin. Bui-Nguyen said his Mindspace by Numinus clinic received Health Canadas approval on May 5 to care for a patient who had undergone several unsuccessful treatments for depression.

Mindspace by Numinus CEO Payton Nyquvest said psychedelics have the potential to become a widespread treatment. As Health Canada continues to approve more requests, he hopes the recognition will make the treatment much more accessible.

Health Canada on Jan. 5 restored its Special Access Program abolished under former prime minister Stephen Harper in 2013 allowing health-care experts to request access to restricted drugs that have not yet been authorized for sale in the country.

Related: Numinus Wellness Receives Health Canada Special Access Program Applicant Approval to Provide Psychedelic-assisted Therapy Treatment

See more here:

TDR's Top 5 Psychedelic Developments For The Week Of May 16 - The Dales Report

Throughout history, groups, cultures, religions, and spiritual traditions, worldwide, have looked to breathwork and the use of psychedelic plant medicines to heal, grow, and transform the human experience. In this article, we look at the sacredness of the breath, and recent scientific studies that help us further understand the impact of breathing with Mindfulness Based Interventions (MBIs), combined with psychedelics.

Breathwork is a powerful tool to alter the neurology and psychology of human beings. It helps to regulate and balance the nervous system. When combined with plant medicine the breath can deeply alter, direct, and focus the mind to reset and change perceptions.

The root word for breath in Latin is Spir as in aspire, conspire, expire, inspire, perspire, respiration, respire, spiracle, spirit, transpire, etc. So, its easy to see why the breath has taken center stage historically, in religious and spiritual ceremonies that use chants, prayers, music, ecstatic dance, and symbolism to transcend dogma.

Modern day research has confirmed what sages have known for centuries. Sacred plant medicines and breathwork can help individuals reset, reboot, and reframe traumatic events and connect them with divine intention. We know that trauma challenges, inhibits, and triggers hyperarousal or hypoarousal modes and can dysregulate the autonomic nervous system. A recent study published in the Journal of Psychopharmacology shows that psychedelics and mindfulness-based interventions and breathwork, practiced together could be the future of mental health treatment. [1]

Researchers at Johns Hopkins University conducted[2] both psilocybin and MBI practices. These studies had a combined positive effect on participants who had chronic post-traumatic stress disorder (PTSD). The results of the study are promising and suggest that the combined use can further help people suffering from PTSD. Furthermore, the use of psychedelics in combination with MBIs could be an especially powerful tool to address both the cognitive and emotional aspects of mental illness. The synergistic effect offers both deep personal insights and improved self-regulation to help people recover from mental illness and live happier healthier lives.

MBIs and psychedelics have been shown to affect key aspects of mental health, such as depression, anxiety, and addiction. For example, a recent meta-analysis of 47 clinical trials found that mindfulness meditation is an effective treatment for reducing symptoms of anxiety[3](Creswell et al., 2017). Similarly, multiple studies have shown that psychedelic drugs are effective in treating a variety of mental health disorders such as depression[4](Carhart-Harris et al., 2016), anxiety[5](Grob et al., 2011), and addiction[6](Mithoefer et al., 2011).

Given the promising evidence for both MBIs and psychedelic drugs in the treatment of mental health disorders, it is not surprising that there is growing interest in combining these two approaches. One early study found that a single session of psilocybin-assisted coaching and MBIs were associated with reductions in depression and anxiety, as well as increases in self-compassion and mindfulness[7](Davis et al., 2016). These findings suggest that the combination of psychedelics and MBIs has the potential to powerfully treat mental health disorders.

MBIs and psychedelics help to reset the brains Default Mode Network (DMN), the self-referential side of the brain, which is active during passive rest and mind-wandering, by helping to throttle its activity. A beneficial outcome for people with mental disorders characterized by impaired DMN function. For example, PTSD is associated with reduced activity in the DMN, and psilocybin can increase activity in the DMN in people with PTSD. This suggests that psychedelics could be used to treat a wide range of mental disorders characterized by impaired DMN function. In addition to PTSD, these disorders include depression, anxiety, and addiction. When combined with focused MBIs, individuals can throttle arousal and better regulate.

These studies confirm and lift earlier research done by psychiatrist Stanislav Grof, with his LSD experimentation which focused on healing patients through altered states of consciousness using breathwork. Grofs research into consciousness and healing is still at the heart of modern-day breathwork.

Using an altered state technique called holotropic breathing, patients could self-regulate and achieve altered states of perception without psychedelics, drugs, or medicine. Indigenous, ancient wisdom cultures have seen the power of deep breathing, which scientifically regulates the autonomic nervous system. We humans naturally breathe. Its a part of our autonomic, sympathetic, nervous system, which helps to regulate our bodies. We dont need to think about it. But, when practiced with intention and focus, breathing takes on another role, as the mind is directed to regulate and manage stress levels, as well as recognize, accept, investigate, inquire, and nurture altered states of consciousness for longer periods of time.

MBIs and somatic practices used with psilocybin have effectively treated many individuals with depression. The complementary effects of these treatments are certainly an exciting prospect for future research on this topic.

Authors note:Breathing is a powerful way to change your brain chemistry when used in conjunction with psychedelics. But, you must consider intention, set, setting, and integration when practicing. Seek out help and support. If you are looking for ways to improve your mental health, start by being more mindful of your breath.

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Psychedelics and Mindfulness: The Future of Mental Health? | Microdose - Microdose Psychedelic Insights

The Catalyst Summit on psychedelic medicine returns for its third iteration today, running through Sunday, and its all taking place live, in glorious in-person 3D at Queens University in Kingston, Ontario.

But have no fear. If youre nowhere near Kingston, the event is being live streamed and tickets are still available for that option.

Taking a look at the lineup of attending speakers, one finds myriad domestic and international policymakers, business leaders, academic researchers, scientists, mental health practitioners, and consumers of psychedelic medicine.

Whether attending in person or partaking of the online remote options, here are three speakers you wont want to miss.

At this point, most everyone with a remote interest in mushrooms has likely heard of this mycologist, but thats no reason to turn down the chance to hear him speak.

Stamets is the author of seven books, an Invention Ambassador for the American Association for the Advancement of Science, and was inducted into The Explorers Club in 2020. He has received numerous awards, including the National Mycologist Award from the North American Mycological Association, and the Gordon & Tina Wasson Award from the Mycological Society of America. His work has entered the mainstream of popular culture. In the new Star Trek: Discovery series on CBS, the Science Officer is portrayed by an Astromycologist as Lt. Paul Stamets. Pauls work with mycelium became a central theme of this series.

And dont forget, the unforgettable documentary Fantastic Fungi, currently streaming on Netflix.

As former Clinical Lead of the Psilocybin for Depression trial at Imperial College London, Rosalind Watts, PhD, led a clinical team that facilitated over a hundred psilocybin treatment sessions.

She developed the ACE model (Accept, Connect, Embody) for psychedelic-assisted therapy, which has been used in clinical trials of psilocybin and DMT. Having recognized that safe and effective use of psychedelics requires substantial integration support, Rosalind co-founded the UKs first psychedelic integration group, and is now launching a global online integration community, Accept, Connect, Embody, Restore (ACER) where members will follow a 12-month process together. She has developed a psychometric tool for measuring outcomes of psychedelic therapy (the Watts Connectedness Scale), is clinical track lead on the Synthesis Institutes Psychedelic Practitioner Training, and sits on the clinical advisory board of the Usona Institute, a not-for-profit psilocybin manufacturer and research organization.

You can find out more about Dr. Watts by visiting her website.

Something a little off the beaten path here, but highlighting how psychedelics can help us view societal actions from a macro view. Dr. Dycks chief interests are in the history of psychiatry, mental health, deinstitutionalization and eugenics. She is the author of Psychedelic Psychiatry which examines the history of LSD experimentation and how it fit within broader trends in the changing orientation of psychiatry during the post-World War II period. She is currently working on a CIHR-funded project with Megan Davies (York University) called Open Doors/Closed Ranks. This project relies on an interdisciplinary team of researchers who are comparing processes and experiences related to deinstitutionalization or the closure of long-stay mental hospitals in Nova Scotia, Saskatchewan and British Columbia.

Events like these serve to continue to bring visibility and momentum to the sea change occurring around pubic policy and public perception on psychedelics. As I was reminded recently in a conversation with MindMed CEO Robert Barrow, legislation for drug policy is all about the Congress. And the Congress is made up of impressionable human beings. Data drives decisions, and events like the Catalyst Summit present data by the deluge.

Being based here in the United States, its easy to misunderstand just how different the psychedelic landscape is in Canada, our North Star example of just some of what may ultimately be possible. The CATALYST Summit serves to showcase Canadas psychedelic journey into medicine, society, and commerce through keynote presentations, intimate panel discussions, and networking events.

Even if you cant be there in person, its not too late to get a discounted pass to tune in online.

See the original post here:

CATALYST Summit: 3 Psychedelic Speakers to Catch This Weekend - Psychedelic Spotlight

In early 2021, Rhys Edwards received a Google alert that would transform his life, possibly hopefully for ever. The alert had been set for news about David Nutt, a professor of neuropsychopharmacology. Edwards was interested in Professor Nutts unconventional ideas as an expert in how drugs affect the mind, and particularly on the therapeutic potential of psychedelics.

If youve heard of Prof Nutt, its probably from his most infamous hour, when he was forced to resign as the Labour governments drugs tsar, in 2009. His offence was to say that illegal substances such as cannabis, ecstasy and LSD were less harmful than alcohol and tobacco, a statement he stands by to this day.

The Google alert Edwards opened contained news of a radical treatment for mental health and addiction. The treatment came with Nutts seal of approval and would be available from a private clinic in Bristol run by Canadian biotechnology company Awakn Life Sciences, to any suitable candidates in the UK.

Edwards was immediately interested and eager to know more. He has suffered from depression for most of his life, leading to suicide attempts, stays in psychiatric hospitals and episodes of shockingly brutal self-harm. He tells me hes had a go at pretty much every kind of treatment going.

The approach, which combines medication and psychotherapy delivered to outpatients over a number of weeks, shows startling potential in a field which has made little progress in many decades.

Existing antidepressants are only cleaner versions of those first developed in the 50s, according to Nutt, and there has been no revision of the standard pill a day model. Only 10 per cent of those who may benefit from alcohol intervention treatment receive help and while most stop drinking at first, three-quarters relapse within six months.

We need to do better, says Nutt. Its a maintenance model. Its protecting people from the symptoms but its not getting rid of the cause, and thats something that our new therapy may be able to do.

Ive been invited to a low-key, high-stakes meeting with Nutt, who is also Awakns chief research officer, and other experts as they launch a flagship London clinic, following success in Bristol. All are convinced that it is time to properly explore new options to tackle rising levels of depression and addiction. Nutt, 71, has devoted his career to this.

Psychedelic drugs are the most interesting and innovative developments in this field, he explains.

My own view is that theyre going to revolutionise psychiatry. I dont think theres any doubt about that. I gave a talk to the Royal College of GPs this morning, and they seemed to believe me. The message is getting out there.

As a retired lawyer who made a comfortable sum after selling a consultancy business, Rhys Edwards had plenty of time to read up on the subject from his Somerset home adjacent to the Glastonbury festival site, which he shares with his wife, 10 dogs and a few other animals.

After further research a considerable amount given its unusual nature and the 6,000 price tag he underwent treatment between December 2021 and February this year.

I was on ridiculous amounts of antidepressants, Edwards says. I was pretty stable but it was like being anaesthetised. The only thing they hadnt given me was ECT (electroconvulsive therapy). I was certainly grasping for something that might be my last chance.

He has also drastically cut back on his other medication, giving up one of two heavy duty antidepressants, almost halving the dosage of the other and drinking far less alcohol.

Im not saying Im cured. I still have bad days and I still have depressive episodes. But I can deal with them and put them into context. I feel like Ive got a good life.

But this wonder treatment is ketamine, a drug with a very dark reputation. One of the reasons that it is the first psychedelic legally available for therapeutic use is that we already know so much about it.

Although often dismissed as a horse tranquilliser or party drug, it is a widely used anaesthetic, commonly chosen for use with children and short operations such as fixing dislocated shoulders. A variation called esketamine is already available through the NHS, prescribed as a nasal spray and not offered alongside therapy, which Awakn believes is the key to long-term benefits.

This combination has unique effects on the brain circuitry associated with unhelpful thinking and behavioural patterns, Awakns website states.

It may allow you to work through issues in ways that have not been possible with therapy alone, and help you to relearn the behaviours and thought patterns that hold you back.

The company researches ketamine and MDMA (ecstasy) treatments for alcohol use disorder (AUD). Professor Celia Morgan, who made the ketamine breakthroughs and is head of Awakns ketamine-assisted therapy, runs the Ketamine for Reduction of Alcohol Relapse trial at the University of Exeter. During the Phase II trial involving 96 participants between 2016 and 2020, her findings revealed that low doses of ketamine combined with psychological therapy can help prevent relapse, showing 87 per cent abstinence at six months compared with the usual one quarter.

AUD is a prime focus given its prevalence it affects 400 million people globally but it is hoped that behavioural addictions such as gambling, food and sex may also be candidates.

Whats so exciting is it brings psychology and psychiatry back together, says Nutt.

I certainly think psychiatrists are ready for it. Im not sure about psychologists. It challenges what theyve been telling their patients for a long time that you should never take drugs. Ive had flak for even talking about these treatments.

Other psychedelics including psilocybin (magic mushrooms) and MDMA are also being trialled. There is little evidence of addiction to psychedelics but opiates such as morphine and fentanyl, which are known to be highly addictive, are routinely prescribed by doctors.

When I was invited to attend the opening of the flagship London clinic last month, where the course costs 7,500, the concept still felt somewhat cloak-and-dagger.

Psychedelics have been around for a long time, but the approach is young and the potential dangers of mind-bending drugs and bad trips are embedded into Western culture.

The clinic space is warm and contemporary. It could be a tech start-up or an independent caf as much as a therapy clinic. The name, Awakn, puts me in mind of the TV series Nine Perfect Strangers, in which Nicole Kidmans mysterious guru character invites struggling guests to her unconventional wellness centre. I suppose we are hard-wired to associate anything related to psychedelics as woo-woo. Certainly, Britons will need to lay down some new neural pathways to get on board.

Scientists such as Nutt and Morgan have long suspected the potential of psychedelics. But theyve found it almost impossible to run trials, even though it has been an area of interest for scientific researchers since the 50s, especially in the US.

Alcoholics Anonymous (AA) co-founder Bill Wilson even intended LSD as the 13th step in the organisations approach to addiction, and credits it for his own recovery. Ultimately, he was ostracised for these views.

Psychoactive plants such as ayahuasca and datura have been used therapeutically by those living close to them for centuries.

Wilson took LSD with the psychologist Betty Eisner and psychiatrist Sidney Cohen. Both were at the forefront of American research into how psychedelics could work alongside talking therapy to treat depression and addiction.

But with the war on drugs in the US came the demonisation and criminalisation of these drugs and practices. Most illegal substances were lumped together, bureaucratically and in the general psyche, as public enemy No 1. Eisner and Cohens work was kneecapped.

It remained legal to use MDMA therapeutically until the mid-80s, when the authorities caught up with its popularity as a party drug. Decades on, Nutt and Morgan seem as surprised as anyone that their work is finally available to the public at large. When had they expected this to happen? They laugh. From Nutt it is more of a guffaw. Never, he replies.

In March, the Royal College of Psychiatrists announced a record 4.1 million referrals to mental health services in 2021, urging the Government to publish a fully funded recovery plan. Awakn, of course, plans to be part of that.

Theres no question places like this are going to be important, says Nutt. The cost burden of severe depression is enormous and clinics like this are going to provide better outcomes at a lower cost.

This is no quick fix though. Theyre not having fun, says Nutt of those who have undergone the treatment. Theyre dealing with the damage theyve done to themselves and their families with alcohol or depression, going back to places where theyve been abused.

I viewed it as work from the outset, confirms Edwards. I think it works on a whole lot of levels. Its great fun in places, it can be very intense in others.

Id gone into it wanting to explore my relationship with my parents and I had the experience of meeting them and was able to clear the air. I wrapped them up in my love and sent them off.

The Awakn programme typically takes place over eight weeks and includes 11 psychotherapy sessions, four ketamine sessions of around two hours each (given by injection) and a final post-course evaluation.

During the ketamine sessions clients are settled under a blanket with music and assisted by a clinical specialist, although it is unusual to talk during thispart.

Psychotherapy sessions follow about 24 hours after the ketamine, when the brain is at its optimum plasticity. This is the time when we are best able to create new ways of thinking.

The ketamine allows users to gain a fresh some call it a fully objective or out of body perspective on their lives and past experiences. The psychotherapy which follows gives them the tools to embed this new outlook into their neural pathways.

Each potential client is assessed individually and will have previously tried other treatments such as antidepressants or substance detoxes. The markers for AUD relate more to how alcohol use is affecting someones life than the volume drunk.

Clients include a photographer who had been drinking three or four beers a night but couldnt stop, a retired civil servant who had struggled with drinking for 40 years and a nurse who didnt want her children to grow up using alcohol as she was.

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'I took ketamine to treat my severe depression' - iNews