The rate of psychedelic drug intake is increasing in the United States. A study published in Drug and Alcohol Dependency in 2020 looked at LSD use trends. It found that the rate of people who used LSD in the past year grew 56% from 2015 to 2018.
Psychedelics, such as psilocybin, are linked with improved medical outcomes. Some American cities, and the state of Oregon, have decriminalized the use of psilocybin and other psychedelics. However, they remain federally illegal for sale, use, or possession in the United States.
The current legal status of such drugs makes performing psychedelic clinical trials challenging. Nonetheless, there are such trials taking place around the world. They rely on a steady stream of volunteers. This article outlines the process for those interested in joining a psychedelic clinical trial.
Joining Psychedelics Clinical Trials
Participation in research trials for psychedelics isn’t as straightforward as finding out where one is taking place and volunteering. One must meet certain eligibility criteria before acceptance.
The definition of a clinical trial doesn’t change regardless of the drugs involved.
Psychedelic clinical trials are part of clinical studies on the subject. They aim to uncover the best treatment for people living with certain medical conditions.
The focus is on ketamine, LSD, MDMA, psilocybin, and ibogaine in psychedelics clinical trials. Psilocybin is arguably the most highly-researched of the five psychedelic drugs mentioned.
A General Overview of How to Join a Clinical Trial
Each clinical trial has inclusion and exclusion criteria. For instance, a study may only accept volunteers above or below a certain age range. It may exclude individuals with certain existing medical conditions.
There is a drive to broaden the eligibility criteria of clinical trials to make them more representative. Overly rigid criteria could reduce the accuracy of results and restrict patient access to potentially useful drugs.
A growing number of websites offer a fast way to access clinical trials looking for participants. An example is DoNotPay, a legal services chatbot. It has a Clinical Trials section and enables visitors to choose filters based on:
- Preferred compensation
At this point, the next move is to contact the study’s organizers. However, there are several alternatives, including directly contacting one of the following:
- The Usona Institute
- The Multidisciplinary Association for Psychedelic Studies (MAPS)
- The U.S. National Library of Medicine. This is part of the National Institutes of Health
- COMPASS Pathways
- The Johns Hopkins University Center for Psychedelics & Consciousness Research
All of the above either participate in or sponsor psychedelics clinical trials.
Why Participate in a Psychedelics Clinical Trial?
There are several benefits associated with involvement in psychedelics clinical trials. Individuals with anxiety and depression may find that a drug like psilocybin helps them feel better. Crucially, patients get to use psychedelics legally via a clinical trial.
People looking to quit smoking or consuming alcohol may derive benefits from psychedelics. Also, some psychedelics clinical trials offer a financial reward for joining.
However, please note that there are side effects associated with psychedelic use. Such drugs interfere with serotonin and could cause changes in:
- Sensory perception
- Sexual behavior
Let’s see how someone can get involved in a psychedelics clinical trial for one of five different drugs. In all cases, you can get in touch with the entities mentioned above. Alternatively, visit clinicaltrials.gov and enter the psychedelic drug of choice in the search bar.
How to Embark on Ketamine Clinical Trials
There are several hundred ketamine trials available at present. There are almost 1,000 options on clinicaltrials.gov alone at first. On the left-hand side of the page, there are filters to help narrow down the search. Click on ‘Recruiting’ and ‘Apply.’ This process narrows down the list. Fewer than 200 ketamine clinical trials were looking to recruit at the time of writing, for example.
There is a significant rise in ketamine for depression clinical trials. This is down to research that has already identified the efficacy of the drug in reducing depressive symptoms.
A study published in the Indian Journal of Psychiatry in 2019 looked at how ketamine could help with this condition. The researchers gave the drug to 25 males with severe depression. The result was a significant improvement in anxiety, depression, and severity of illness two weeks and a month after receiving the last dose of ketamine.
Clinical Trials Aim to See if Ketamine Has an Antidepressant Effect
The purpose of such trials involves trying to learn how ketamine affects the areas of the brain involved in regulating mood. Scientists also want to learn if there are unique signatures to help predict who might respond to the drug. Also, they want to see if repeated ketamine doses are safe.
What those who look for ketamine clinical trials for depression will find is that research is ongoing globally.
After clicking on a trial, it is essential to go through the summary. It outlines the aim of the study, along with research procedures and the number of participants. It is often the case where a clinical study will struggle to get enough volunteers. This causes severe delays.
Pay special attention to eligibility criteria. For ketamine clinical trials, inclusion criteria usually consist of:
- Being a native speaker of a specific language; in the United States, English speakers are preferred
- Having the medical condition getting researched
- Being aged 18-65
There are a host of reasons why a clinical study for ketamine may not want a volunteer. Exclusion criteria usually relate to having specific medical issues. Examples include having a history of cardiac disease or renal failure.
Look for the contacts section to discover who to get in touch with. It should also have the location of the trial.
Getting Involved in LSD Clinical Trials
Lysergic acid diethylamide, better known as LSD or acid, is a famous hallucinogenic drug. Proponents suggest it makes a person feel smarter, happier, and healthier. Research to date suggests it is capable of helping patients with depression, anxiety, and addiction.
A review of studies published in Frontiers in Psychiatry in January 2020 looked at the therapeutic use of LSD in psychiatry. It mentioned the heterogeneity of the clinical trials performed to date. However, it also found that positive results were observed.
The researchers suggested that LSD’s strongest use is potentially for the treatment of alcoholism.
There are significantly fewer LSD trials than ketamine trials. They number in the dozens rather than the hundreds. Also, relatively few take place in the United States. Research centers in Switzerland and Germany are recruiting for several LSD ketamine trials.
Apart from clinicaltrials.gov, it is worth getting in touch with facilities via Psychedelic Support.
Can I Participate in MDMA Clinical Trials?
One of the most common reasons to engage in an MDMA clinical trial is to see if it combats post-traumatic stress disorder (PTSD). MDMA’s full name is 3,4-methylenedioxy-methamphetamine. It is a synthetic drug that alters the perception and mood of the user.
A study published in the Annals of General Psychiatry in 2020 looked at MDMA-assisted psychotherapy for people diagnosed with treatment-resistant PTSD. It concluded that the drug could help people with psychological trauma, particularly when existing treatments have proven ineffective. It also suggested that more research was needed.
MAPS is one of the best options for those interested in MDMA trials. It acts as a clinical trial sponsor to obtain approval for the prescription use of MDMA to treat PTSD. It conducts its trials under the guidance and regulations of the FDA.
MAPS outlines its MDMA-Assisted Psychotherapy Study Protocols on its website. It plans to ensure the drug is used for PTSD with FDA-approval by 2023. Interested parties can view clinical trials and apply.
What About Psilocybin Clinical Trials?
Psilocybin trials are more prevalent than other drugs on this list. In general, people who use this drug do so via magic mushrooms, fungi that contain psilocybin. It is one of the more tolerated psychedelic drugs though it is legal in very few places.
One of the main facets of psilocybin research is to determine its efficacy for depression.
Results from a randomized clinical trial were published in JAMA Psychiatry in November 2020. The study looked at the effects of psilocybin-assisted therapy on major depressive disorder.
The study involved a total of 27 people. They found that a treatment featuring psilocybin was more effective than typical antidepressant medications. Alan Davis, one of the study’s authors, said the effect was four times greater.
Things to Note Before Trying to Enroll in a Psilocybin Clinical Trial
Again, it is important to remember that all clinical trials in the U.S. that test a medical device or drug in humans have to register on clinicaltrials.gov. Eligibility depends on the study and its aims. Typical inclusion criteria for psilocybin clinical trials include:
- Having a support person
- Being aged 21 to 65
- Suffering from moderate to severe depression
- Enduring a depressive episode for at least 60 days
Exclusion criteria tend to include:
- Pregnant and nursing women
- Patients with a medical condition such as epilepsy, schizophrenia, or cardiovascular disease
It is typical for pharmaceutical companies to sponsor these trials. This is primarily because they want to generate an FDA-approved medication. The Usona Institute is one of the few nonprofit organizations involved in this form of research.
Here is what participants can expect:
- Blinded trials have a placebo control group and a psilocybin group. Many volunteers are surprised when they don’t receive the drug. Some are disappointed to the extent that they leave the trial.
- They should not be on drugs that could interfere with the psychedelic. However, discontinuing medication can cause medical problems for some individuals.
- The design of the study varies according to the trial, sometimes drastically. For example, some clinical trials involved all-day sessions and overnight stays. Those who sign up must understand that they could miss days at work. They may also have to arrange childcare.
A Quick Overview of Ibogaine Clinical Trials
Ibogaine is a naturally-occurring intoxicating substance found in certain plant families. An ibogaine clinical trial may look at the drug’s use in helping with opioid use disorder or drug addiction.
A study published in Frontiers in Pharmacology in 2018 looked at ibogaine as a means of helping with opioid and cocaine withdrawals. It found that the drug could help opioid-dependent patients transition to sobriety.
As a result, the level of research relating to ibogaine has ramped up in recent times. It is likely a response to the opioid epidemic, which claims tens of thousands of lives annually.
MAPS is also heavily involved in ibogaine research. However, there is also a Global Ibogaine Therapy Alliance, which provides details of active clinical trials.
How Do Clinical Trials Work?
Psychedelics clinical trials work the same as for any other substance. They advance through four phases and collect data to evaluate the efficacy and safety of drugs.
Initially, a new substance goes through various tests in human cells or animals to get preliminary data on safety and effectiveness. After an initial review, the FDA can approve and allow a research team to go through the first phase. Here is what each of the four phases of a clinical trial consists of:
- Phase I: This trial tests an experimental treatment on a relatively small group of healthy individuals. The group size is typically between 20 and 80 people. The goal is to get further information on side effects and safety. The researchers also hope to determine the correct dosage of the drug.
- Phase II: This phase can include up to 300 people in some cases. The emphasis of this section revolves around effectiveness. Phase II aims to gain initial data on whether a drug works in people with a certain medical condition. This phase can last several years as it continues to monitor safety.
- Phase III: Along with more information on safety and efficacy, Phase III involves studying varying doses of the drug amongst different populations. Researchers also combine the drug with others. A Phase II study can have up to 3,000 people. At this point, the FDA approves the experimental drug or device if it believes that the trial results are positive.
- Phase IV: The effectiveness and safety of the drug are tested on large sections of the population. In some cases, side effects don’t become apparent for a long time. However, the FDA has already approved the drug.
A Long Road for Psychedelics
While there are thousands of clinical trials for psychedelics, mainly ketamine, few have advanced beyond Phase II. In fact, none of the psilocybin clinical trials listed at clinicaltrials.gov are on Phase III. Only around 40% of the ketamine studies have made it that far.
Remember, Phase II can last several years. The likely outcome is that pharmaceutical companies will create synthetic versions of psychedelics. Some organizations are already deep into this process.
Joining a Psychedelics Clinical Trial – The Process
After finding a clinical trial of interest, the next step is to contact the study coordinator or someone connected to the trial. They will set up a screening appointment to ensure the applicant qualifies. At this stage, volunteers are encouraged to ask questions about the study. They should also let their physicians know about the trial.
Here is the process once someone agrees to join:
- Staff involved in the trial explain it in more detail. This includes answering the participant’s questions.
- The volunteer signs an informed consent form.
- Then they are screened to ensure they qualify.
- If accepted, the participant schedules a baseline visit. This involves the researchers conducting physical and cognitive tests.
- The participant is assigned to a control or treatment group randomly. They will receive either the drug or a placebo without knowing which one they are using.
- The volunteer and family members follow trial procedures and report issues to the trial’s team.
- Participants are permitted to visit the research site at scheduled times to have further evaluations or to enter discussions with the researcher.
- Volunteers should see their regular doctor throughout the study.
- Once the study ends, the researchers gather and analyze the data they find. Participants should be made aware of how long the study is in advance. The research team must also state whether the patient will continue receiving treatment at the study’s conclusion. Finally, the researchers must outline how they intend to inform volunteers about the study’s results.
Questions to Ask Before Participating in a Psychedelic Clinical Trial
Potential volunteers in clinical trials should ask numerous questions before proceeding. This is especially the case when psychedelic drugs are involved. Here is a sample of the questions one should ask:
- What is the aim of the study?
- What treatments will I have? Will they cause pain?
- How much of the psychedelic will I consume?
- What are the likely side effects and risks?
- How do I know if the treatment is working?
- Where is the trial taking place?
- Are overnight stays required?
- How long does the trial last?
- How do you intend to keep me safe during the study?
- What is the protocol if a volunteer’s condition gets worse?
- Will the study cost me anything in terms of travel, expenses, etc.? Will I get reimbursed?
- Does this study offer any financial compensation?
- Will you follow up on my health after the study’s conclusion?
- Do I need a study partner?
- Who do I get in contact with if I have more questions?
Final Thoughts on Joining a Psychedelics Clinical Trial
Before a possible new treatment reaches patients, detailed clinical trials are necessary. Each drug or device must go through four distinct phases. It is a long and costly process that lasts up to seven years on average. The cost of researching and developing a successful drug can exceed $2.6 billion.
Problems with recruitment mean that a high proportion of clinical trials are delayed. This all represents a major challenge that psychedelics proponents must overcome. Without FDA-approval, no psychedelic drug will reach the legal marketplace. This is only possible after successfully making it to Phase IV of a clinical trial. For this to happen, more people must volunteer for psychedelics clinical trials.
At present, hundreds of institutions are recruiting participants. They need people for ketamine, LSD, MDMA, psilocybin, and ibogaine clinical trials.
There are several ways to get in touch with clinical trial researchers. One of the most common methods involves looking for studies on clinicaltrials.gov. However, you can also check out MAPS and several other institutions and contact them directly.
Perhaps in a few years, enough clinical research will exist to finally allow FDA approval of psychedelics. There are also a huge number of trials taking place all around the world. International readers should see if any medical institutions in their country are recruiting for psychedelics clinical trials.