Awakn Life Sciences will be carrying out the first-ever study investigating the use of ketamine treatment for gambling addiction, using psychedelic-assisted psychotherapy.
Biotechnology company Awakn Life Sciences, which is due to open two psychedelic therapy clinics in the UK in the next few months, and more next year, has received ethical committee approval to carry out a study investigating the use of ketamine-assisted psychotherapy for the treatment of gambling addiction.
Gambling addiction is a serious issue, with the burden of harm being similar to the harm attributed to major depressive disorder and alcohol misuse and dependence, according to the World Health Organisation (WHO), which is substantially higher than harm attributed to drug dependence disorder. It is estimated that in the UK 8.66 million people are problem gamblers, with the issue costing between £260m and £1.2bn per year.
Currently, there are no licensed pharmacological treatments of gambling disorder available.
Treatment for gambling addiction
Through the exploration of a new treatment approach for gambling addiction, the study will look at whether ketamine administration can modify the reward memories associated with gambling. This will tackle both the urge to gamble and the “superstitious thinking” that accompanies gambling.
The study, which has now initiated recruitment for participants, is to be led by Ph.D. professor of psychopharmacology at the University of Exeter, Celia Morgan, who is head of Awakn’s ketamine-assisted psychotherapy for addiction and an internationally respected expert in the therapeutic use of ketamine.
Professor Morgan commented: “This study is an exciting first step toward a new treatment for gambling disorder, and one which will give new insights into the neurobiology of this damaging and often overlooked addiction, we are delighted that Awakn is able to take the lead in developing solutions to address this growing unmet treatment need.”
Awakn, whose strategy is to develop and deliver proprietary psychedelic therapeutics to better treat both substance addiction and behavioural addiction, hopes the study will give hope of a new treatment for people whose lives have been destroyed by gambling.
The company also has an extensive preclinical and clinical IP portfolio focused on substance and behavioural addiction treatment. This includes 10 patent filings covering multiple chemical series and clinical targets, a completed Phase II ab trial for ketamine-assisted psychotherapy to treat Alcohol Use Disorder (AUD), a planned Phase IIb trial for MDMA as a treatment for AUD and a two-stage pre-clinical drug discovery programme developing next generation psychedelic medicines to treat addiction.
Clerkenwell Health is launching a free UK psychedelic therapist training programme
In this article, communications associate at Clerkenwell Health, Arda Ozcubukcu, discusses how the company is working to ensure psychedelic-assisted therapy is easily adopted by mainstream healthcare systems in the UK.
In recent weeks, much has been made of psychedelic drugs’ potential to redefine mental health treatment. As the sector becomes more visible, major players have started to re-evaluate their traditional roles within the psychedelic research ecosystem.
We’ve seen non-profit organisations like Multidisciplinary Association for Psychedelic Studies (MAPS) start to conduct clinical studies, an extremely uncommon phenomenon due to the vast amounts of funding required, as well as patient groups such as the Psychedelic Participant Advocacy Network (PsyPAN) influence the design of research processes.
Traditionally, a clinical research organisation’s (CRO) sole role is to action the research it has been commissioned to conduct. However, in a sector full of unknowns and firsts, where the necessary infrastructure is being established in real-time, a CRO has significantly more potential. Clerkenwell Health is on a mission to realise this potential, by redefining what a CRO can offer, and becoming a hub for innovation.
As an emerging sector, psychedelic drug development faces a number of bottlenecks, and at Clerkenwell Health we don’t wait for others to solve problems, we tackle them head on.
The UK is fast becoming a central hub for psychedelic research thanks to the conducive regulatory environment brought about by post-Brexit sovereignty, which is attracting business and boosting innovation. Increasing numbers of psychedelic companies are moving their clinical operations to the UK, thus increasing the demand for psychedelic specialty therapists.
A major issue within the psychedelic research ecosystem is the lack of therapists able to deliver psychedelic-assisted therapy, which is an essential component to maximise the therapeutic benefits of psychedelics.
With drugs now progressing to the later stages of development, clinical trials will require the delivery of psychedelic-assisted therapy at a much larger scale, increasing the demand for therapists even further. If sustainable ways of meeting this demand are not developed now, there will be serious capacity problems when these drugs hit the market.
Due to a lack of evidence showing which therapy model works with psychedelics most effectively, there are currently no standardised training opportunities provided by an independent body such as British Association for Counselling and Psychotherapy (BACP).
Limited therapy training opportunities exist, and those that do fail to fully consider the realities of the health system or the therapists who want to specialise in psychedelic therapy. Although some training programmes are offered by drug developers, it does not equip therapists to work across different compounds or disorders, whilst training run independent of developers can be expensive and time-consuming, making training accessible only to those who can afford the time and financial commitment. The situation, if it continues, will fail to create a workforce ready to deliver suitable psychedelic-assisted therapy at the scale required.
At Clerkenwell, our concern is that expensive programmes qualify therapists irrespective of their capabilities. That’s why we have designed a training programme that is free, disease- and compound-agnostic and minimises the time to commit for those interested to participate.
Our programme uses Acceptance and Commitment Therapy (ACT), a model that already has a solid evidence base and is practiced within the health system. This ensures the therapy aspect of psychedelic-assisted therapy is easily adopted by mainstream healthcare systems through medical and regulatory buy-in, which is vital for widespread patient access to these treatments.
ACT seems to work effectively with psychedelics and using them together can maximise the therapeutic outcomes of both the therapy and the drug. Therapists can also keep their skills fresh by practicing ACT without psychedelics and are therefore more readily available to deliver psychedelic-assisted therapy post-marketing approval.
Scaling up psychedelic-assisted therapy is not an easy task, but one that is necessary for its successful adoption in the psychedelic research ecosystem. It’s time for the excitement of developing new psychedelic drugs to mature into developing delivery infrastructure, starting with the workforce.
As a CRO, Clerkenwell Health can help facilitate this process by paving the way for standardised certified training and acting as the cement that supports the psychedelic research ecosystem for different actors to build on. By investing in, innovating, and operating a centre of excellence for psychedelic-assisted therapy right in the heart of Europe’s most vibrant psychedelic research ecosystem, we can become the go-to partner for drug developers, regulators, and researchers who want to fundamentally change the face of mental health care.
Bicycle Day: where are we 80 years since the first LSD trip?
On Bicycle Day 2022, we explore LSD’s journey from its first bicycle ride to MK Ultra to the treatment of addiction.
In 1943, Swiss chemist Albert Hofmann took the first LSD trip – what is it looking like for the compound today?
Switzerland, 19 April, 1943. Chemist Albert Hofmann takes 250micrograms of LSD, proceeding to ride his bike as its effects kick in. So, Bicycle Day is born – a celebration of the first LSD trip.
Hofmann initially synthesised LSD from ergot in 1938 to use as an active pharmaceutical ingredient. Leaving the compound to one side, Hofmann decided to revisit it again in 1943. He felt a slight effect after accidentally absorbing a small amount of LSD through his fingertip three days before 19 April which led to the purposeful first trip. Hofmann later went on to describe the compound as “sacred”.
Since 1943, LSD has built up a rich history. Fuelling the countercultural revolution of the 1960s and animating the minds of great writers, poets, musicians and artists, LSD was previously researched for a number of different uses.
One of the leading researchers was Stanislav Grof, who investigated the compound for its therapeutic use for different mental conditions and addiction. This research showed promising results, and as pointed out in a recent paper, reported limited adverse side effects.
However, the compound also had its dark side. It was used as part of the CIA’s secret MK Ultra programme (1953 – 1973). The programme looked at techniques such as hypnosis and used psychoactive substances for mind control and psychological torture tactics to harness against the Soviet Bloc during the Cold War.
In one experiment, “Operation Midnight Climax”, the CIA employed female sex workers to draw in men, when LSD would be used and the mens’ behaviour observed. Purportedly, renowned writer and psychedelic advocate, Ken Kesey, Acid Test pioneer, was also a volunteer in the MK Ultra programme.
Whilst Grateful Dead kept on truckin’ at their psychedelic concerts, and more young people began experimenting with psychedelic drugs, Nixon declared the worldwide “war on drugs” in 1971. Nixon labelled drug abuse as “America’s public enemy number one” leading to the scheduling of psychedelics in the highest category of the UN Convention on Psychotropic Substances.
Since its scheduling, the last 50 years has seen a scientific censorship unknown in history. Scientists and researchers have been unable to investigate the compound, along with other psychedelics, for their potential therapeutic uses – despite previous research indicating they hold promise.
However, a handful of organisations and researchers have been able to overcome the regulatory and financial hurdles limiting access to compounds such as LSD, and now the world is beginning to see the blossoming of a new psychedelic era.
This time, it is gearing towards the medical application of LSD. Although the cultural impact of psychedelics is easily seen, the spotlight is being put on the revolutionary potential of LSD and other psychedelics in helping the millions across the world living with poor mental health and addiction. From macrodosing to microdosing, LSD without the trip and assisted-psychotherapy, a new wave of scientific investigation is forming.
Discover some of the recent scientific research developments with LSD from Psychedelic Health:
Study to explore effects of LSD microdosing
LSD findings could help understand how the brain generates behaviour
LSD trial for the treatment of adult ADHD initiated
New study to prevent unfounded LSD therapy patents
Novel findings presented on LSD and psilocybin
Is psilocybin safe to administer under medical supervision?
Drug Science has carried out a systematic review of adverse events reported in clinical trials.
Results from a systematic review have led to the conclusion that psilocybin is safe to administer in clinical settings, and that there is a need to revise the classification of psilocybin as a Schedule 1 substance.
Psilocybin is currently classed as a Schedule 1 under the United Nations Convention on Psychotropic Substances (1971). Any substance classified as a Schedule 1 substance fits the criteria of being highly addictive, having no therapeutic and having a lack of safety for use under medical supervision.
However, psilocybin is currently being administered in clinical settings for research exploring the compound’s efficacy as a therapy for mental health disorders and different addictions, such as nicotine dependence.
The systemic review from Drug Science investigated whether clinical trials of psilocybin support the third category of its Schedule I designation, that “there is a lack of accepted safety for use of the drug or other substance under medical supervision”.
The researchers analysed reports in the PubMed database for “adverse events, drug tolerability, and drug safety” stating that “while nearly all the publications reported behavioural and biological effects of the drug, these findings were not included in this review unless it was clearly stated to be an adverse event or safety risk.”
The results demonstrated that 25 of the 52 publications in the analysis did not contain any reference to adverse events, drug safety, or drug tolerability with 27 publications documenting administration of psilocybin on over 800 occasions to 550 individuals.
The authors state that these 27 publications reported no serious or significant adverse events and positive drug tolerability, suggesting that “psilocybin is safe to administer under proper medical supervision”.
Of the adverse events that were reported, the authors state they were generally considered to be “transient and mild, the most common being headaches”, bar a handful of events that were considered to be more severe. However, the conclusions were that “psilocybin was not responsible for these events”.
The authors state: “The reviewed clinical trials demonstrated rigorous medical and psychological screening processes prior to participant enrollment. All studies excluded participants of vulnerable populations (e.g. history of psychosis), in order to avoid serious adverse events.
“This practice is utilised for medications across all levels of scheduling, in the event that a drug may be safe and effective for certain populations, while having increased rates of adverse effects for others (e.g. one would not administer a beta-blocker to a hypotensive patient).
“The participant selection criteria for many of the reviewed trials required prior experience with psychedelics, further screening out individuals who may be prone to psychedelic-related adverse events.”
They go on to say: “Considerable evidence suggests that psilocybin is generally well-tolerated when administered in a controlled setting. Federally and socially accepted selective serotonin reuptake inhibitors also pose a considerable level of risk, and the acceptable level of risk associated with psilocybin should not serve as a barrier to those whom it could provide positively life-altering outcomes.”
The authors also emphasise the role of set and setting as an important factor in the safe administration of psilocybin.
- Top UK and European academics join Clerkenwell Health advisory board
- Psychedelics for addiction research gets $2.7m grant
- Beckley Psytech strengthens leadership team as it progresses clinical pipeline
- Patient approved to receive psilocybin therapy for MDD
- World’s first study on ketamine for behavioural addiction now complete
- New partnership to harness digital tools to enhance psychedelic care
- World’s first study on ketamine for behavioural addiction now complete
- New partnership to harness digital tools to enhance psychedelic care
- DEA grants approval for the manufacture of psychedelic compounds
- Numinus receives Health Canada SAP approval for psilocybin therapy
- Clerkenwell Health is launching a free UK psychedelic therapist training programme
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