A Double-blind, Randomized Trial Examining the Preliminary Efficacy of Psilocybin Therapy for People With Chronic Low Back Pain
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in pain interference
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This trial is testing various doses of psilocybin in combination with add-on medications. Participants, study staff and clinical assessors will be blinded to individual treatment conditions until study close-out. The clinician administered instruments will be administered by different clinical study staff than the facilitators who provide the preparation, psilocybin therapy, and integration sessions.
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 (Drug)
Psilocybin in combination with Zolpidem
Single dose of Psilocybin (1mg-30mg) in combination with zolpidem
干预措施: Psilocybin therapy with Zolpidem (Drug)
Psilocybin in combination with Placebo
Single dose of Psilocybin (1mg-30mg) in combination with placebo
干预措施: Psilocybin therapy with Placebo (Drug)
Psilocybin in combination with Modafinil
Single dose of Psilocybin (1mg-30mg) in combination with modafinil
干预措施: Psilocybin therapy with Modafinil (Drug)
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)
研究者
Joshua Woolley, MD, PhD
Associate Professor
University of California, San Francisco