Observational Pilot Study to Explore the Social and Health Impacts of a New Model of Care in Oregon: Psilocybin Services on Alcoholism
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Frequency of Heavy Drinking
研究概览
简要总结
The purpose for this study is to observe the real world experience of participants who are receiving psilocybin in the context of (alcoholism) Alcohol Use Disorder without intervening in the model of care. The study team will engage directly with the participants to examine the outcomes in participants who have been deemed eligible and appropriate to receive psilocybin services at Oregon's Innertrek Patient Service Center (PSC) and who are willing to participate in the People Science pilot study to share their experience concurrently. Since the participant will be making the informed decision to voluntarily take part in this concurrent observational study, there will be no "doctor-patient" relationship between the participant and the People Science Study Investigator.
Study participants will receive the standard of care and medical management from Oregon's Innertrek Patient Service Center facilitators as deemed appropriate per their existing guidelines and practices. People Science will solely be operating as an observer, using an agnostic research data capture system to collect outcomes and follow participant experiences throughout the course of their treatment journey. The study will incorporate participant-reported outcome measures, questionnaires and surveys. The primary endpoint in collecting study data will be to observe the impact of the Psilocybin-Assisted care model on the frequency of heavy drinking days through quantitative and qualitative data analysis for people who struggle with alcohol use. Non-quantitative narratives will also be captured. Throughout the People Science study observations, participants will be in the direct care of the Oregon Patient Service Center facilitators. Findings from this study will contribute knowledge toward the understanding of the use of psilocybin in individuals with self-described alcoholism (AUD).
详细描述
Alcoholism or Alcohol Use Disorder (AUD) is a chronic and relapsing condition characterized by an inability to control alcohol consumption, leading to significant health, social, and economic consequences. Despite the availability of various treatment modalities, including pharmacotherapies and behavioral interventions, relapse rates remain high, with many individuals failing to achieve long-term abstinence or control. This has spurred interest in exploring novel therapeutic approaches and care models, including the potential use of psychedelic compounds such as psilocybin used in a supportive care environment.
Psilocybin, a naturally occurring psychoactive substance found in certain species of mushrooms, has garnered attention for its potential therapeutic effects in treating mental health disorders such as depression, anxiety, and post-traumatic stress disorder. More recently, research has suggested that psilocybin may be beneficial in addressing substance use disorders, including Alcohol Use Disorder. The mechanism by which psilocybin exerts its effects appears to involve the modulation of neural circuits related to mood regulation, behavior, and self-reflection, which can facilitate profound psychological experiences that may promote lasting changes in behavior and cognition.
Early clinical trials have shown promising results, indicating that psilocybin, when administered in a therapeutic setting, can reduce alcohol consumption and cravings in individuals with Alcohol Use Disorder. In a study published in Journal of American Medical Association of Psychiatry, researchers from New York University Grossman School of Medicine found that heavy alcohol consumption among people with alcohol use disorders was 83 percent lower among participants who had received psilocybin over an 8-month period following the psilocybin administration and almost half of participants who received psilocybin stopped drinking alcohol altogether. These studies highlight the potential for psilocybin to act as a catalyst for psychological insights and behavioral change when combined with psychotherapy or a calming and supportive environment, offering a new avenue for treatment-resistant cases of Alcohol Use Disorder.
In Oregon, excessive alcohol consumption causes 2,000 deaths each year, making it the third leading cause of preventable death in the state. There is a glaring need for support for Oregonians facing alcohol and substance use disorders. Alongside more traditional treatment and harm reduction models, Psilocybin shows promise for treating alcohol and substance disorders. Oregon's state-regulated psilocybin program offers an opportunity to advance real world research on Psilocybin for treating alcohol and substance use disorders.
In 2020, Oregon voters approved a ballot measure (Measure 109) to create the world's first state-regulated psilocybin program to improve the physical, mental, and social well-being of all people. The measure required that the Oregon Health Authority (OHA) create a licensing and regulatory framework for a safe, accessible and equitable program. After a two-year rule making period, licensed service centers are now open and providing psilocybin services to clients in Oregon. Psilocybin services are only delivered in licensed service centers, under the supervision of a trained facilitator, and psilocybin can only be consumed in the service center during that supervised session. There are no retail sales, no off-site consumption, possession, or production of psilocybin (outside of licensed manufacturers).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Frequency of Heavy Drinking
时间窗: 12 months
The primary objective is to study the effects of Oregon Health Authority's (OHA's) psilocybin service program on frequency of heavy drinking among people with alcohol use disorder. This will measured by Percentage of number of heavy drinking days at baseline versus in 30 day increments after completing psilocybin services.
次要结局
- Number of Drinking Days(12 months)
- Days of Complete Abstinence(12 months)
- Diagnostic and Statistical Manual of Mental Disorder (DSM) early remission(12 months)
- Alcohol Craving(12 months)
- Spiritual Significance(12 months)
- Treatment Completion Rate(12 months)
- Adverse Events(12 months)
