National Institute on Alcohol Abuse & Alcoholism

GREENWICH, Conn., Sept. 12, 2024 /PRNewswire/ -- B.More Inc., a 501(c)(3) non-profit, clinical-stage biopharmaceutical company dedicated to the development of psychedelic medicines for substance abuse disorders, proudly announces that its collaborator, Dr. Michael Bogenschutz, Director of the NYU Langone Center for Psychedelic Medicine, has been awarded a $3.8 million grant from the National Institute of Alcohol Abuse and Alcoholism (NIAAA). This significant grant will: (1) elucidate the brain mechanisms of psilocybin-assisted treatment for alcohol use disorder (AUD), (2) add to the growing body of evidence regarding the safety and efficacy of psilocybin in AUD, and (3) begin to answer the question of logistics for provision of care for psilocybin-assisted treatment in real-world treatment settings. The trial will take place in collaboration with Silver Hill Hospital (SSH), where patients will be recruited and receive residential treatment during the trial. In support of this critical research, B.More Inc. will provide and cover the cost of the cGMP psilocybin to be used in the trial, as well as fund the retention of an independent monitor to ensure high quality data capture acceptable for an eventual New Drug Application (NDA). This trial, in a long-standing substance abuse treatment center, should provide a road map for eventual commercialization, and evidence for cost effective insurance reimbursement. The involvement of NIAAA funding is confirmation of growing interest in the potential of these novel medicines. According to Carey Turnbull, Co-founder, and CEO of B.More Inc., "The awarding of this NIAAA grant is a significant recognition of Dr. Bogenschutz's pioneering work in developing new treatment modalities for alcohol use disorder. Building on the groundbreaking results of his well-publicized Phase 2a study on psilocybin for AUD, this trial has the potential to pave the way for more effective treatments for AUD and other substance use disorders, providing new hope for millions struggling with addiction. We are pleased to partner with Dr. Bogenschutz and his team to support this important work." The double-blind, randomized, placebo-controlled Phase 2 trial aims to explore the therapeutic neural mechanisms of psilocybin in AUD patients using advanced functional magnetic resonance imaging (fMRI). The study will investigate treatment differences between high-dose (30 mg) and inactive placebo, focusing on changes in fMRI metrics, drinking outcomes, and self-reported measures of negative emotionality, craving, and executive function. Additionally, the trial will seek to identify neural predictors of successful treatment outcomes, particularly in response to high-dose psilocybin. In collaboration with SHH, the trial will randomize 120 participants from SHH's 28-day residential treatment program. Primary outcomes will measure changes in neural activation, connectivity, and self-reported alcohol use and related psychological measures. SSH, in New Canaan, Connecticut, is a nationally recognized, not-for-profit hospital for the treatment of psychiatric and addictive disorders, treating over 3,500 patients annually. 'We are pleased to be a part of this crucial trial advancing the care of individuals with alcohol use disorder," said Andrew J. Gerber, MD, PhD, President and Medical Director of Silver Hill and site director for this study. "We are excited to embark on this significant study, which has the potential to help advance the treatment of alcohol use disorder," said Dr. Michael Bogenschutz. "The generous support from the NIAAA underscores the promise of psilocybin as a transformative therapy for substance abuse disorders. We are committed to advancing our understanding of how psilocybin impacts neural mechanisms and contributes to recovery." About B.More Founded in 2017 by Carey and Claudia Turnbull, B.More is a 501(c)(3) non-profit, clinical-stage biopharmaceutical company with a mission to develop better treatment options for those struggling with alcohol use disorder and other substance use disorders. Named after Claudia Turnbull's brother, Brett Moore, who died of a drug overdose 50 years ago, B.More is focused on the development and commercialization of psychedelic medicines that offer the potential to dramatically improve the lives of those for whom current treatment options have not proved effective. With researchers at the NYU Grossman School of Medicine, B.More is advancing clinical research to help these individuals, and their loved ones, live a better tomorrow. For more information, please visit Logo - SOURCE B.More Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Researchers have found that even low to moderate alcohol use by pregnant patients may contribute to subtle changes in their babies' prenatal development, including lower birth length and a shorter duration of gestation. University of New Mexico researchers have found that even low to moderate alcohol use by pregnant patients may contribute to subtle changes in their babies' prenatal development, including lower birth length and a shorter duration of gestation. In a new paper published in the journal Alcohol Clinical & Experimental Research, a team led by Ludmila Bakhireva, MD, PhD, MPH, professor and assistant dean for Clinical and Translational Research in the UNM College of Pharmacy, also reported some sex-related differences in the effects of drinking during pregnancy on the developing baby. "In exploratory analyses, the effect on gestational age was more pronounced in male infants, and for birth length it actually was stronger in females," Bakhireva said. She cautioned that these effects should be interpreted with caution because of the study's limited statistical power to conduct sex-specific analyses and the challenges of accounting for other contributing factors. The paper reported on three prospective studies conducted at UNM over the course of 10 years that followed 281 participants, most of whom were recruited in the second trimester of their pregnancies and then followed, along with their children, for some time afterward, she said. There is a good deal of research on the prenatal effects of heavy alcohol use, usually defined as 14 drinks per week, or binge drinking, defined as four drinks or more per occasion, Bakhireva said. "We know quite a bit from these earlier studies of heavy alcohol use about the effect on prenatal outcomes, especially preterm delivery and growth restriction, as well as neurodevelopmental outcomes, but we specifically focused on more moderate alcohol exposure because it's much more prevalent," she said. Early pregnancy is a critical period for the formation of organs in the developing fetus, making it a particularly vulnerable window for alcohol exposure, Bakhireva said. "Almost everybody drinks before they know they are pregnant, and risky drinking before pregnancy is predictive of drinking later on," she said. "That's a unique aspect of the study. We carefully looked at the patterns of drinking around conception and early pregnancy." Most of the participants substantially reduced their drinking or stopped altogether once they learned they were pregnant, Bakhireva said. Even with reduced alcohol there were some deficits seen in both male and female infants, however. She emphasizes that larger studies that combine samples across the country are needed to replicate the findings and examine sex-specific effects further. Bakhireva is the principal investigator of the HEALthy Brain and Child Development study at UNM, part of a national initiative that will recruit 7,500 parent-child pairs and follow them for up to 10 years. "With that type of multi-site study, we'll have sufficient power to look at the effects of different patterns and timing of alcohol use in even a more nuanced way," she said. The paper underscores messaging from the National Institute of Alcohol Abuse and Alcoholism -- that no amount of drinking during pregnancy is safe, she said. "I think this study, as well as prior preclinical studies, show that even moderate alcohol use might have negative effects. The degree of negative effects might vary, and it is important to address alcohol use without the stigma often associated with it, but overall, if we try to encourage abstinence from alcohol during pregnancy, we will maximize positive health and developmental outcomes for the children."

Young to middle-aged women who reported drinking eight or more alcoholic beverages per week--more than one per day, on average--were significantly more likely to develop coronary heart disease compared with those who drank less, finds a study presented at the American College of Cardiology's Annual Scientific Session. The risk was highest among both men and women who reported heavy episodic drinking, or 'binge' drinking, and the link between alcohol and heart disease appears to be especially strong among women, according to the findings. Young to middle-aged women who reported drinking eight or more alcoholic beverages per week -- more than one per day, on average -- were significantly more likely to develop coronary heart disease compared with those who drank less, finds a study presented at the American College of Cardiology's Annual Scientific Session. The risk was highest among both men and women who reported heavy episodic drinking, or "binge" drinking, and the link between alcohol and heart disease appears to be especially strong among women, according to the findings. The study focused on 18- to 65-year-old adults and is among the largest and most diverse studies to date examining the links between alcohol and heart disease. Heart attacks and other forms of heart disease are on the rise in younger populations in the U.S., fueling concern about worsening health outcomes. At the same time, alcohol use and binge drinking have become more common among women than in previous decades. "When it comes to binge drinking, both men and women with excess alcohol consumption had a higher risk of heart disease," said Jamal Rana, MD, PhD, FACC, a cardiologist with The Permanente Medical Group, adjunct investigator in the Division of Research at Kaiser Permanente Northern California and the study's lead author. "For women, we find consistently higher risk even without binge drinking. I wasn't expecting these results among women in this lower age group because we usually see increased risk for heart disease among older women. It was definitely surprising." The researchers used data from more than 430,000 people who received care in the Kaiser Permanente Northern California integrated health organization, including nearly 243,000 men and 189,000 women. Participants on average were 44 years old and did not have heart disease at the start of the study. Information on participants' alcohol intake was collected during primary care visits using the health organization's standard "Alcohol as a Vital Sign" screening initiative, which includes visual reference posters to help patients estimate alcohol quantities according to standard measurements. Researchers analyzed the relationship between the level of alcohol intake participants reported in routine assessments from 2014-2015 and coronary heart disease diagnoses during the four-year period that followed. Coronary heart disease occurs when the arteries that supply blood to the heart become narrowed, limiting blood flow. This condition can cause chest pain and acute events, such as a heart attack. Based on self-report assessments, researchers categorized participants' overall alcohol intake as low (one to two drinks per week for both men and women), moderate (three to 14 drinks per week for men and three to seven drinks per week for women), or high (15 or more drinks per week for men and eight or more drinks per week for women). They separately categorized each participant as either engaging in binge drinking or not. Binge drinking was defined as more than four drinks for men or more than three drinks for women in a single day in the past three months. People who reported no alcohol use were not included in the study. The researchers adjusted the data to account for age, physical activity, smoking and other known cardiovascular risk factors. Overall, 3,108 study participants were diagnosed with coronary heart disease during the four-year follow-up period, and the incidence of coronary heart disease increased with higher levels of alcohol consumption. Among women, those who reported high alcohol intake had a 45% higher risk of heart disease compared with those reporting low intake and had a 29% higher risk compared with those reporting moderate intake. The difference was greatest among individuals in the binge drinking category; women in this category were 68% more likely to develop heart disease compared with women reporting moderate intake. Men with high overall intake were 33% more likely to develop heart disease compared with men who had moderate intake. "Women feel they're protected against heart disease until they're older, but this study shows that even when you're young or middle aged, if you are a heavy alcohol user or binge drink, you are at risk for coronary heart disease," Rana said. The results showed no significant difference in risk between people who reported moderate versus low alcohol intake, regardless of whether they also were categorized as binge drinking. Alcohol has been shown to raise blood pressure and lead to metabolic changes that are associated with inflammation and obesity. Women also process alcohol differently than men. Researchers said the study calls attention to the health risks of alcohol consumption and underscores the importance of considering alcohol use in heart disease risk assessment and prevention efforts. "When it comes to heart disease, the number one thing that comes to mind is smoking, and we do not think about alcohol as one of the vital signs," Rana said. "I think a lot more awareness is needed, and alcohol should be part of routine health assessments moving forward." One limitation of the study is that people tend to under-report their alcohol intake when asked by a health care provider. As a result, the study likely provides conservative estimates of the heart disease risk associated with alcohol consumption. The researchers also said the manner in which alcohol screening is performed in a health clinic can influence how patients and clinicians discuss the risks of alcohol consumption, and that further research could help determine optimal strategies. This study was funded by a grant from the National Institute on Alcohol Abuse and Alcoholism.