Psilocybin in Chronic Low Back Pain and Depression
Recruiting · Baltimore, Maryland
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
This study seeks to provide insight on psilocybin's effects on mechanisms of chronic pain among patients with co-morbid chronic low back pain and depression (CLBP+D). Participants will receive either a single high-dose of psilocybin (25mg absolute dose) or methylphenidate (40mg absolute dose).
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
This study seeks to provide insight on psilocybin's effects on mechanisms of chronic pain among patients with co-morbid chronic low back pain and depression (CLBP+D). Participants will receive either a single high-dose of psilocybin (25mg absolute dose) or methylphenidate (40mg absolute dose). Participants will be asked to complete assessments of pain, depressive symptoms, and more general questionnaires regarding the participants experiences during the experimental sessions and the associated enduring effects.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Ages 21 to 80
- •Ongoing low back pain for at least 3 months, where low back pain is present on at least half of the days in the past 6 months (and low back pain must be the main problem)
- •At least moderate depression symptoms on the GRID-HAMD depression scale (score ≥ 17)
- •Able to read and speak English and have at least a high school level of education
- •Can follow study rules about avoiding psychoactive drugs and keeping other treatments stable
🚫 You may not be able to join if…
- •Anyone with a lifetime history of serious psychiatric (other than depression) or neurological disorders such as bipolar disorder, psychosis, or seizure disorder
- •Anyone with a history of severe substance use disorder in the past 2 years, or a current moderate substance use disorder in the past 6 months
- •Anyone with clinically significant suicidal thoughts in the past 6 months, or a suicide attempt in the past 5 years
- •Anyone with medical problems that make psilocybin unsafe (example given: cardiovascular conditions) or abnormal liver enzymes (AST or ALT > 2× normal)
- •Anyone pregnant or nursing, or women who can become pregnant but are not using effective birth control
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 21–80
- !Some conditions may not be a fit: Obesity / overweight, Heart / cardiovascular disease, High blood pressure, Anxiety
- !Not for people who are pregnant or breastfeeding
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
This is an early-stage study. The treatment has gone through laboratory and preliminary testing before being studied in people here.
What you need to know before you apply
What is this study testing?+
This study seeks to provide insight on psilocybin's effects on mechanisms of chronic pain among patients with co-morbid chronic low back pain and depression (CLBP+D). Participants will receive either a single high-dose of psilocybin (25mg absolute dose) or methylphenidate (40mg absolute dose).
Is it safe? Who makes sure of that?+
This is an early study (Phase 1), focused mostly on safety. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Source: ClinicalTrials.gov · NCT06355414 · Locations: Maryland