A Double-blind, Randomized Trial Examining the Preliminary Efficacy of Psilocybin Therapy for People With Chronic Low Back Pain
概览
- 阶段
- 1 期
- 干预措施
- Psilocybin therapy with Zolpidem and Modafinil
- 疾病 / 适应症
- Chronic Low-back Pain
- 发起方
- Joshua Woolley, MD, PhD
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in pain interference
- 状态
- 进行中（未招募）
- 最后更新
- 3天前
概览
简要总结
This study evaluates whether psilocybin therapy helps patients cope with chronic low back pain more effectively. Patients may be recruited at Stanford and University of California San Francisco (UCSF), study procedures will occur at UCSF. Each participant will receive a dose of psilocybin with possibly one or more other drugs. Participants will undergo two preparation sessions, a dosing session, three integration sessions to discuss their psilocybin experience, and several follow up sessions.
详细描述
Chronic pain is associated with higher levels of pain-related distress, depression, emotional dysfunction, helplessness, hopelessness, and suicidality. Psilocybin is a psychoactive drug that may be well-suited to easing the psychological and emotional symptoms of distress associated with chronic pain. Previous studies testing psilocybin therapy have shown improvements on multiple behavioral and psychiatric outcomes, but it is unknown whether psilocybin therapy similarly enables patients to cope with chronic pain more effectively. The investigators will determine whether psilocybin therapy improves patients' ability to cope with chronic low back pain. If psilocybin therapy is an effective treatment in this population, its use could be incorporated into interventions for chronic low back pain and other psychological conditions.
研究者
Joshua Woolley, MD, PhD
Associate Professor
University of California, San Francisco
入排标准
入选标准
- •Age 25 to 70 years old
- •Comfortable speaking and writing in English
- •Diagnosed with chronic low back pain
- •Able to attend all in-person visits at UCSF as well as virtual visits
- •Has tried at least two previous medications/ procedures and physical therapy trials for low back pain
排除标准
- •Chronic low back pain that is attributed to malignancy, subacute or acute fracture or infection
- •Low back pain with radiation below the knee
- •Low back pain with neurologic signs present
- •Regular use of medications that may have problematic interactions with psilocybin, including but not limited to dopamine agonists, MAO inhibitors, antipsychotics, and stimulants
- •A health condition that makes study unsafe or unfeasible, determined by study physicians
研究组 & 干预措施
Psilocybin in combination with Zolpidem and Modafinil
Single dose of Psilocybin (1mg-30mg) in combination with zolpidem and modafinil
干预措施: Psilocybin therapy with Zolpidem and Modafinil
Psilocybin in combination with Zolpidem
Single dose of Psilocybin (1mg-30mg) in combination with zolpidem
干预措施: Psilocybin therapy with Zolpidem
Psilocybin in combination with Placebo
Single dose of Psilocybin (1mg-30mg) in combination with placebo
干预措施: Psilocybin therapy with Placebo
Psilocybin in combination with Modafinil
Single dose of Psilocybin (1mg-30mg) in combination with modafinil
干预措施: Psilocybin therapy with Modafinil
结局指标
主要结局
Change in pain interference
时间窗: Baseline, 1-month after psilocybin session
The Brief Pain Inventory-Interference subscale (BPI) will be used to assess how pain interferes with a variety of daily activities (e.g., walking, lifting, mood, sleep, relationships). Seven items are rated on a scale from 0 (does not interfere) to 10 (completely interferes) for a total possible score ranging from 0 to 70. Higher scores represent greater interference from pain.
次要结局
- Change in pain interference(Baseline, 1-week, and 3-months)
- Change in average pain intensity(Baseline, 1-week, 1-month, and 3-months after psilocybin session)
- Change in depressive symptom severity(Baseline, pre-dosing session, 5-days, 11-days, and 77-days after psilocybin session)
- Change in clinical depressive symptom severity(Baseline, 1-week, 1-month, and 3-months after psilocybin session)