Safety and Feasibility of Psilocybin in Methamphetamine Use Disorder in a Community-Based Sample
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Incidence of serious adverse events associated with oral psilocybin
研究概览
简要总结
The purpose of this research study is to investigate the safety and feasibility of two (2) oral doses of psilocybin when combined with behavioral support for methamphetamine use disorder (MUD). Participants have a diagnosis of methamphetamine use disorder (MUD). Participants can expect to be actively engaged in the study for up to 26 weeks.
详细描述
The objective of this study is to determine the safety of psilocybin in adult participants with MUD.
Eligible participants will be adults with methamphetamine use disorder recruited from the community. After physical and psychological screening, and at least 6 hours of psychological support for the psilocybin dosing, each participant will ingest 1 oral dose of psilocybin. All dosing sessions will be attended by 2 specially trained facilitators, in a dedicated Session Room at the University of Wisconsin School of Pharmacy. After eight hours of observation in the dosing room, the participant will stay overnight in the hospital Clinical Research Unit, and complete an integration session with at least one of the session facilitators before discharge to home. Approximately 4 weeks after the first dose, the participant will receive a second oral dose of psilocybin, with the same length of observation.
Participants who decide not to proceed to the second dose will complete two additional integration sessions and study measures through the two-month follow-up.
If you are interested in participating in this study, please fill out a brief 1-minute survey at the link in the "More Information" section at the bottom of this record.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of methamphetamine use disorder
排除标准
- •Positive urine pregnancy at any time point during screening or study participation
- •Inadequately treated hypertension, defined as 2 blood pressure readings, 10 minutes apart, of greater than 140/90 mmHg systolic/diastolic
- •Current acute coronary syndrome or angina
- •History of heart transplant or stroke
- •Current use of and inability or unwillingness to taper off of medications that may interact with psilocybin
- •Current insulin dependence, due to Type I or Type II diabetes
研究组 & 干预措施
Oral Psilocybin
Psilocybin with psychological support: Psilocybin will be administered in the form of capsules, taken orally with water. Each participant will receive 2 doses, approximately 4 weeks apart.
干预措施: Psilocybin (Drug)
结局指标
主要结局
Incidence of serious adverse events associated with oral psilocybin
时间窗: Up to 26 weeks
Incidence of serious adverse events attributable to psilocybin as categorized according to NCI Common Toxicity Criteria version 4.0. and assigned attribution (probably, possibly, and not related).
次要结局
- Number of participants who complete at least one dose of psilocybin(Up to 26 weeks)
- Number of participants who complete two-month follow-up visit(Up to 26 weeks)
- Changes in substance use(Up to 26 weeks)
- Functional changes in psychedelic and addiction-related neurocircuitry using functional magnetic resonance imaging.(Up to 26 weeks)