Cannabis News
Shrooms Legalized Before Weed? – FDA Posts Guidelines for Doing Research on Psychedelics
An important step has been taken toward the acceptance and legitimacy of psychedelic therapies with the Food and Drug Administration (FDA) release of a ground-breaking draft guidance addressing the special issues investigating psychedelics for therapeutic reasons. This change occurs when municipalities and states nationwide push more for the study and control of drugs like psilocybin and MDMA. The FDA’s draft guidance provides researchers with a framework to design clinical trials that yield interpretable results, supporting the development of psychedelic medicines. As the draft undergoes a public comment period, stakeholders can shape the final guidance, ensuring it incorporates diverse perspectives and expertise. As the therapeutic potential of psychedelics continues to receive attention, this advice paves the way for a new era of scientific investigation and the potential creation of novel treatments for mental health illnesses.
The FDA’s Draft Guidance on Psychedelic Research:
The release of the FDA’s draft guidance on psychedelic research marks a significant milestone in mental health treatment. The 14-page document provides researchers with a comprehensive framework to conduct studies on psychedelic drugs, which have shown initial promise in treating mood, anxiety, and substance use disorders. Covering various aspects of drug development, the guidance offers insights into trial conduct, data collection, subject safety, and new drug application requirements. By outlining the unique challenges inherent in designing psychedelic drug development programs, the FDA aims to assist researchers in designing studies that yield reliable and interpretable results, supporting future drug applications.
Researchers exploring the therapeutic potential of psychedelics face distinct considerations compared to traditional pharmaceutical research. The draft guidance emphasizes the psychoactive nature of many psychedelics, which sets them apart from conventional medicines. This characteristic increases the potential for abuse and necessitates careful consideration throughout drug development. Moreover, the guidance acknowledges the regulatory complexities associated with entheogenic plants and fungi like psilocybin, classified as Schedule I drugs. Researchers must navigate a more complex registration process with the DEA to obtain these substances for study purposes. The FDA’s guidance provides recommendations on addressing these regulatory challenges effectively.
The draft guidance also underscores the importance of ensuring subject safety during psychedelic research. Given the unique characteristics of psychedelics, researchers must develop safety monitoring strategies tailored to these substances. Additionally, the guidance highlights the significance of characterizing dose-response relationships and evaluating the durability of treatment effects. These considerations help establish the effectiveness and long-term impact of psychedelic therapies. Recognizing the integral role of psychotherapy in psychedelic drug development, the guidance advises researchers to carefully integrate psychotherapy into psychedelic-assisted treatments while minimizing bias in subsequent therapy sessions. By addressing these factors, the FDA aims to enhance the quality and validity of research outcomes in psychedelic-assisted therapy.
Unique Considerations in Psychedelic Research:
The FDA’s draft guidance on psychedelic research sheds light on the unique considerations researchers must address when studying psychedelic substances. A significant aspect highlighted in the guidance is the psychoactive nature of these compounds. Unlike traditional medications, psychedelics induce profound alterations in perception, cognition, and mood, necessitating careful management of the acute experience during clinical trials. Researchers must develop innovative methodologies and measures to capture the therapeutic effects of psychedelics while accounting for the subjective and context-dependent nature of the psychedelic experience. This entails designing studies that can effectively evaluate the safety and efficacy of these substances in a controlled and standardized manner.
In addition to the psychoactive effects, the regulatory landscape surrounding psychedelic substances presents a distinct challenge for researchers. Entheogenic plants and fungi, such as psilocybin, fall under Schedule I classification according to the Controlled Substances Act. This classification imposes stringent regulations and complicates obtaining these substances for research purposes. The FDA provides researchers with recommendations and guidance on navigating the regulatory hurdles associated with Schedule I substances, ensuring compliance with legal and ethical requirements while facilitating access to these compounds for research.
The guidance emphasizes the importance of subject safety in psychedelic research. Given the unique effects and potential risks associated with psychedelics, researchers must establish robust safety protocols and evaluate the risk-benefit profile of their studies. The guidance emphasizes the need for comprehensive safety monitoring throughout the treatment process, including pre-session preparation, administration, and post-session integration and support.
The Impact of FDA Guidance on Psychedelic-Assisted Therapy
The release of the FDA’s draft guidance on psychedelic research carries significant implications for the emerging field of psychedelic-assisted therapy. With growing interest and promising results, this therapeutic approach combines the administration of psychedelics with psychotherapy to treat various mental health conditions. The FDA’s guidance acknowledges this innovative treatment modality and offers considerations specifically tailored to conducting clinical trials in psychedelic-assisted therapy.
One key focus of the guidance is the importance of maintaining treatment blinding in clinical trials. Since therapists monitoring the sessions can often discern the treatment assignment based on the subject’s behavior, it is crucial to minimize potential biases. The guidance suggests that in-session monitors should not be involved in post-session psychotherapy to prevent their knowledge of the treatment from influencing subsequent therapy sessions. By implementing strategies to ensure blinding, researchers can uphold the integrity of the trial and obtain more reliable and unbiased results.
Additionally, the FDA’s guidance underscores the significance of exploring the role of psychotherapy within psychedelic-assisted therapy. Psychedelics enhance the therapeutic process by facilitating introspection, emotional breakthroughs, and personal insights. Understanding the interplay between the psychedelic experience and psychotherapy is vital for optimizing treatment outcomes. The guidance encourages researchers to incorporate appropriate psychotherapeutic techniques and develop protocols that effectively integrate the unique effects of psychedelics into the therapeutic process.
Moreover, the draft guidance emphasizes the importance of characterizing dose-response relationships and treatment durability in psychedelic-assisted therapy. Psychedelics often exhibit dose-dependent effects, meaning the therapeutic outcomes may vary based on the dosage. Researchers are encouraged to investigate the optimal dosage range for medicinal purposes. Additionally, evaluating the durability of treatment effects is crucial to determine the long-term benefits and sustainability of psychedelic-assisted therapy. By comprehensively studying dose-response relationships and treatment durability, researchers can refine treatment protocols and better understand these substances’ therapeutic potential.
Bottom Line
The FDA’s release of draft guidance on psychedelic research signifies a significant step forward in understanding the therapeutic potential of these substances. The guidance document aims to assist researchers in designing clinical trials that meet the evidentiary standards required for drug development. As interest in psychedelics continues to grow and lawmakers advocate for reform, the FDA’s guidance provides a roadmap for conducting research and advancing the field of psychedelic-assisted therapy. With continued research, legislative support, and regulatory guidance, psychedelic medicines have the potential to revolutionize mental health treatments and provide relief for individuals suffering from mood disorders, anxiety, and addiction.
PSYCHEDELICS GO LEGAL BEFORE WEED, READ ON…
“How Long Does One Puff of Weed Stay in Your System?”… This topic can be difficult to answer since it is dependent on elements such as the size of the hit and what constitutes a “one hit.” If you take a large bong pull then cough, it might linger in your system for 5-7 days. A moderate dose from a joint can last 3-5 days, whereas a few hits from a vaporizer may last 1-3 days.
The length of time that marijuana stays in the body varies based on a number of factors, including metabolism, THC levels, frequency of use, and hydration.
Delta-9-tetrahydrocannabinol, or THC, is the primary psychoactive component of cannabis. THC and its metabolites, which remain in your body long after the effects have subsided, are detected by drug tests.
Since these metabolites are fat-soluble, they cling to bodily fat molecules. They could thus take a while to fully pass through your system, particularly if your body fat percentage is higher.
THC is absorbed by tissues and organs (including the brain, heart, and fat) and converted by the liver into chemicals such as 11-hydroxy-THC and carboxy-THC. Cannabis is eliminated in feces at a rate of around 65%, while urine accounts for 20%. The leftover amount might be kept within the body.
THC deposited in bodily tissues ultimately re-enters the circulation and is processed by the liver. For frequent users, THC accumulates in fatty tissues quicker than it can be removed, thus it may be detectable in drug tests for days or weeks following consumption.
The detection time varies according to the amount and frequency of cannabis usage. Higher dosages and regular usage result in longer detection times.
The type of drug test also affects detection windows. Blood and saliva tests typically detect cannabis metabolites for shorter periods, while urine and hair samples can reveal use for weeks or even months. In some cases, hair tests have detected cannabis use over 90 days after consumption.
Detection Windows for Various Cannabis Drug Tests
Urine Tests
Among all drug tests, urine testing is the most commonly used method for screening for drug use in an individual.
Detection times vary, but a 2017 review suggests the following windows for cannabis in urine after last use:
– Single-use (e.g., one joint): up to 3 days
– Moderate use (around 4 times a week): 5–7 days
– Chronic use (daily): 10–15 days
– Chronic heavy use (multiple times daily): over 30 days
Blood Tests
Blood tests generally detect recent cannabis use, typically within 2–12 hours after consumption. However, in cases of heavy use, cannabis has been detected up to 30 days later. Chronic heavy use can extend the detection period in the bloodstream.
Saliva Tests
THC can enter saliva through secondhand cannabis smoke, but THC metabolites are only present if you’ve personally smoked or ingested cannabis.
Saliva testing has a short detection window and can sometimes identify cannabis use on the same day. A 2020 review found that THC was detectable in the saliva of frequent users for up to 72 hours after use, and it may remain in saliva longer than in blood following recent use.
In areas where cannabis is illegal, saliva testing is often used for roadside screenings.
Hair Tests
Hair follicle tests can detect cannabis use for up to 90 days. After use, cannabinoids reach the hair follicles through small blood vessels and from sebum and sweat surrounding the hair.
Hair grows at approximately 0.5 inches per month, so a 1.5-inch segment of hair close to the scalp can reveal cannabis use over the past three months.
Factors Affecting THC and Metabolite Retention
The length of time THC and its metabolites stay in your system depends on various factors. Some, like body mass index (BMI) and metabolic rate, relate to individual body processing, not the drug itself.
Other factors are specific to cannabis use, including:
– Dosage: How much you consume
– Frequency: How often you use cannabis
– Method of consumption: Smoking, dabbing, edibles, or sublingual
– THC potency: Higher potency can extend detection time
Higher doses and more frequent use generally extend THC retention. Cannabis consumed orally may remain in the system slightly longer than smoked cannabis, and stronger cannabis strains, higher in THC, may also stay detectable for a longer period.
How Quickly Do the Effects of Cannabis Set In?
When smoking cannabis, effects appear almost immediately, while ingested cannabis may take 1–3 hours to peak.
The psychoactive component THC produces a “high” with common effects such as:
– Altered senses, including perception of time
– Mood changes
– Difficulty with thinking and problem-solving
– Impaired memory
Other short-term effects can include:
– Anxiety and confusion
– Decreased coordination
– Dry mouth and eyes
– Nausea or lightheadedness
– Trouble focusing
– Increased appetite
– Rapid heart rate
– Restlessness and sleepiness
In rare cases, high doses may lead to hallucinations, delusions, or acute psychosis.
Regular cannabis use may have additional mental and physical effects. While research is ongoing, cannabis use may increase the risk of:
– Cognitive issues like memory loss
– Cardiovascular problems including heart disease and stroke
– Respiratory illnesses such as bronchitis or lung infections
– Mood disorders like depression and anxiety
Cannabis use during pregnancy can negatively impact fetal growth and development.
Duration of Effects
Short-term effects generally taper off within 1–3 hours, but for chronic users, some long-term effects may last days, weeks, or even months. Certain effects may even be permanent.
Bottom Line
The amount of time that cannabis remains in your system following a single use varies greatly depending on individual characteristics such as body fat, metabolism, frequency of use, and mode of intake. Frequent users may maintain traces of THC for weeks, whereas infrequent users may test positive for as little as a few days. Hair tests can disclose usage for up to 90 days, while blood and saliva tests identify more recent use. Urine tests are the most popular and have varying detection durations. The duration that THC and its metabolites are detectable will ultimately depend on a number of factors, including dose, strength, and individual body chemistry.
PEE IN A CUP COMING UP, READ ON..
Is kratom addictive? Discover the potential for dependence on Kratom, the risks involved with its use, and how to approach its consumption responsibly.
From 2011 to 2017, over 1,800 calls to poison centers involved kratom in the U.S. This significant number highlights the concern regarding kratom addiction.
However, without Food and Drug Administration (FDA) oversight, and due to various consumption methods like teas and capsules, there are significant health risks. Safe use of kratom is now in question due to these issues.
Research debates how dependence develops, outlining signs like loss of control and withdrawal symptoms. These signs are seen in regular kratom users. Ironically, some people switch from drugs like heroin to kratom, looking for a legal alternative.
Understanding Kratom: Origins and Prevalence
Kratom comes from the Mitragyna speciosa tree in Southeast Asia. It can act like a stimulant or like opioids, based on how much you take. People use it in different ways, for a small energy boost or stronger effects at higher doses.
The legal status of kratom in the U.S. is complicated and changing. It’s a hot topic because some worry about its misuse. It’s still legal in several states. This shows how different places handle drug rules. The National Institute on Drug Abuse is looking into its medical benefits. But, the FDA hasn’t approved it for medical use yet. The DEA calls it a “drug of concern,” which means policies might change.
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From 2011 to 2017, poison control centers in the U.S. got over 1,800 reports about kratom. This shows it’s widely used and might pose health risks.
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Kratom’s main ingredients bind to opioid receptors very strongly, stronger than morphine even. This fact is key to understanding its effects.
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As more people use kratom, more are reporting serious health problems. These include liver and heart issues, and tough withdrawal symptoms, particularly in those already sick.
The statistics show mounting worries about kratom in the U.S. As its use grows, it’s becoming more important to health policies and laws. What happens next will depend on further research and legal decisions.
Is Kratom Addictive: Investigating the Substance’s Nature
The question of kratom’s addictiveness focuses on how it affects brain receptors and its long-term health implications. The ongoing debate highlights concerns about dependence and the risk of addiction. Scientists are closely looking at these issues.
How Kratom Works in the Brain
Kratom’s main alkaloids, mitragynine and 7-hydroxymitragynine, bind to the brain’s opioid receptors, similar to painkillers and narcotics. This connection suggests a potential risk of dependence. These alkaloids are key to kratom’s pain relief but also point to possible addiction concerns, especially with frequent, high-dose usage.
Patterns and Consequences of Long-term Use
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Using kratom often, especially in large doses, can increase the risk of dependence and intense withdrawal symptoms, similar to opioid withdrawal.
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Although some use it for pain or to improve mood, long-term kratom users might see serious health problems, like liver damage and mental health issues.
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Withdrawal symptoms, including irritability, nausea, and sleep problems, show kratom’s impact on one’s physical and mental health.
Assessment of Addiction Risks
Studies indicate a significant risk of addiction to kratom, especially with high doses or frequent use. Dependence develops as the body gets used to kratom, leading to tolerance and a need for more to feel its effects. Withdrawal symptoms emphasize this risk, as highlighted by health experts.
Physiological Effects: Kratom’s Impact on the Body
There is a lot of debate about the safety and use of kratom. This herbal extract comes from the Mitragyna speciosa plant. It has drawn attention for its possible harmful effects on the body. The FDA has issued many warnings about kratom, raising safety concerns.
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Kratom Adverse Effects: Kratom users have reported side effects like nausea, vomiting, and confusion. More serious issues include high blood pressure and liver damage. These problems highlight the risks of using kratom.
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Herbal Extract Safety: Some kratom products contain heavy metals and pathogens. These can cause severe health issues, including death. This shows the importance of safety in herbal products.
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FDA Warnings and Regulations: The FDA has linked kratom to over 35 deaths and warns against using it. They point out the lack of medical uses and the risk of addiction.
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Physiological Impact: Kratom’s effects depend on the dose and the user’s body. Yet, it can lead to dangerous outcomes like liver damage and seizures.
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Safety Concerns from Authorities: Federal agencies like the DEA are worried about kratom’s safety. Although not a controlled substance, monitoring suggests users should be careful.
Kratom might offer temporary relief for some ailments, but it comes with significant risks. The FDA’s warnings should make people think twice. If considering kratom, it’s crucial to talk to a doctor first. Experts stress the need for safety and caution with herbal extracts.
Conclusion
Kratom’s role in health and regulation is complex, with views and research findings widely varied. Some people use kratom for its claimed health benefits, but it’s a hot topic. Experts advise caution and suggest consulting a doctor before using kratom due to the unclear effects.
Clinical studies using scores like SOWS and COWS haven’t confirmed withdrawal symptoms from kratom. This adds to the debate, especially when some users report withdrawal. This makes kratom a controversial subject among different findings and user experiences.
When it comes to treating opioid addiction, kratom can be both helpful and harmful. Some have used it successfully to fight addiction. Yet, some states have banned it. This highlights the need for regulations and consistent product quality. It also raises questions about kratom’s legal status due to mixed actions by authorities.
The situation shows how complex kratom is in the realm of substance use and law. Without clear evidence supporting either its benefits or risks, it poses a challenge. More research is needed to guide regulations and health advice. For now, anyone thinking of using kratom should be careful, seek medical advice, and keep up with laws and health guidelines.
WHAT IS KRATOM ANYWAY? READ ON…
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