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FDA Fast-Tracks Review Process for Three Psychedelic Drugs

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FDA Fast-Tracks Review Process for Three Psychedelic Drugs

The federal Food and Drug Administration (FDA) announced Friday that it has granted priority review vouchers to three psychedelic drugs being developed to treat certain mental health conditions, Associated Press reports.

The drugs include two psilocybin-based drugs made to treat depression and a psychedelic made using methylone, a substance similar to MDMA, which is designed to treat post-traumatic stress disorder (PTSD). They are not guaranteed to get approved with coupons, but the review period for the drugs should be shortened.

“We owe it to our nation’s veterans and all Americans suffering from these conditions to evaluate these potential therapies as a matter of urgency.” – FDA Commissioner Marty Makary in a statement

The FDA has also approved initial testing for an ibogaine-based drug, DemeRx, as a treatment for alcohol use disorder, the report said.

The announcement comes about a week after President Donald Trump (R) signed an executive order runs the FDA to expedite the review of psychedelics, including psilocybin and ibogaine, as potential mental health treatments.

Currently, all psychedelics are Schedule I under the Controlled Substances Act, reserved for drugs with a “high potential for abuse” and “no currently accepted medical use” in the US.

Based in Portland, Oregon, Graham is the editor-in-chief of Ganjapreneur. He has been writing about the legalization landscape since 2012 and has contributed to Ganjapreneur since our official launch in…

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Medical Cannabis

New Study Suggests THC and CBD Could Help Treat Agitation in Dementia Patients

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New Study Suggests THC and CBD Could Help Treat Agitation in Dementia Patients

A formulation of THC and CBD significantly reduced agitation among patients with end-stage dementia in a first-of-its-kind clinical trial, MedicalXpress reports.

The multicenter, randomized, double-blind, placebo-controlled Phase II study (known as the LiBBY trial, for the recent benefits of cannabidiol and tetrahydrocannabinol) included 120 hospice-eligible participants with Alzheimer’s disease or other types of dementia they were experiencing. The findings were presented July 14 at the Alzheimer’s Association International Conference in London by researchers from the Medical University of South Carolina and Georgetown University.

Participants received either a placebo or a fast-acting oil suspension containing isolated THC and CBD. After two weeks, patients in the THC/CBD group showed a significantly greater reduction in mean agitation scores than the placebo group. The researchers said the improvement was maintained at 12 weeks.

A secondary analysis also found that 83.9% of patients in the THC/CBD group were rated as significantly less anxious after two weeks, compared to 30.5% in the placebo group. At 12 weeks, 87.2% of treatment group participants showed improvement, compared to 23.6% of placebo participants.

“Rarely do we see close to 90% of patients in a trial who respond positively to a new drug,” said Jacobo Mintzer, MD, of the Medical University of South Carolina and co-investigator of the study.

While the findings are promising, the researchers also noted that the treatment was a precisely formulated medical product administered under clinical supervision and may differ significantly from commercially available cannabis products.

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Education

More Than 85% of U.S. Healthcare Professionals Believe Cannabis Has Medical Utility

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More Than 85% of U.S. Healthcare Professionals Believe Cannabis Has Medical Utility

According to survey data published in Journal of Cannabis Research.

The anonymous, web-based survey involved 879 health care professionals, most of whom reported that they had already encountered cannabis use among their patients. Eighty-nine percent of respondents said they had patients who use cannabis, while 87% said they believe cannabis has therapeutic promise. Ninety-five percent said they support the legal use of medical cannabis, and 74% said they would be open to recommending medical cannabis to patients.

The survey group included mental health professionals, registered nurses, physicians, and advanced practice providers. Respondents rated their knowledge of cannabis higher for its risks and therapeutic indications, but the researchers found much lower scores when participants were tested on objective knowledge of cannabis-related risks, therapeutic uses, and mechanisms of action.

The most common sources of knowledge about cannabis were personal experience and popular media, cited by 76% and 73% of respondents, respectively. The researchers also found that fewer respondents had received structured clinical training on cannabis, although many expressed openness to using it in practice.

The most cited concerns about the clinical use of cannabis included a lack of trained providers, potential exploitation of patients, recreational misuse, and the risk of psychosis. Greater openness to the clinical use of cannabis was associated with higher knowledge of self-esteem, younger age, professional role, and less worry.

The study authors said the findings indicate a need for structured training on cannabis pharmacology, dosing, contraindications, and legal and ethical considerations, as well as better systems for monitoring the use of cannabis in patient care.

NORML Deputy Director Paul Armentano said the findings reflect the growing acceptance of medical cannabis among healthcare providers.

“The use and efficacy of medical cannabis is now widely accepted by health care professionals,” said Armentano. in a statement. “As more doctors, nurses and others integrate medical cannabis into their clinical practices, it is vital that medical associations, institutions and educational curricula alike include and embrace cannabis as a mainstream and established therapeutic option for patients.”

discovery are consistent with a 2021 study published in Cannabis and cannabinoid researchwhich found that nearly 69% of more than 2,200 US clinicians believed that cannabis has medical benefits. In that survey, 27% of respondents said they had prescribed cannabis to a patient, while 60% incorrectly identified their state’s cannabis legalization policy.

Ganjapreneur: Providing everyday knowledge since 2014, the leading digital business magazine for cannabis industry professionals. to join our community of over 40,000 cannabis entrepreneurs.

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Medicine

New Study Investigates Mental Health Risks of Teen Cannabis Use

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New Study Investigates Mental Health Risks of Teen Cannabis Use

A new study in JAMA Health Forum tracking over 463,000 adolescents aged 13 to 17 until age 26 found that adolescents who reported using cannabis in the past year faced significantly higher risks of later developing psychotic disorders, bipolar disorders, depression and anxiety, with the risk of psychotic and bipolar disorders nearly doubling among cannabis users.

The research was based on electronic health records from routine pediatric visits between 2016 and 2023 and found that cannabis use typically preceded a psychiatric diagnosis by approximately 2 years. Unlike previous research that focused primarily on heavy use or diagnosed cannabis use disorder, this study captured any self-reported use in the past year, and the authors noted that the findings held even after accounting for prior mental health conditions and other substance use. The researchers also noted that cannabis use was more common among teens on Medicaid and in lower-income neighborhoods.

The study was funded by a grant from the NIH’s National Institute on Drug Abuse, the federal government’s primary funder of drug research, and is also the largest single funder of cannabis research overall, primarily studying cannabis misuse and adverse effects on researching cannabis as a potential medical treatment. This imbalance can be attributed to NIDA’s stated mission, which focuses on the causes and consequences of drug use and addiction rather than on research into the therapeutic use of cannabis or other drugs.

The mental health risks for young cannabis users have been understated numerous studies since the 1980s, and proponents of cannabis legalization, who acknowledge the risks, have emphasized the fact that in a regulated market, access to cannabis is more tightly controlled.

While the authors of this particular study suggest the widespread “commercialization” of high-potency cannabis as a major cause of issues arising from underage use, other recent studies have concluded that legalization it doesn’t dramatically increases the consumption of minors.

Ganjapreneur: Providing everyday knowledge since 2014, the leading digital business magazine for cannabis industry professionals. to join our community of over 40,000 cannabis entrepreneurs.

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