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Stimulant

Psilocybin for Chronic Lower Back Pain and Depression

Phase 1
Recruiting
Led By David B Yaden, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post drug administration up to 8 hours, 1-week follow-up, 1-month follow-up
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to understand how psilocybin affects chronic pain in patients with chronic low back pain and depression. Participants will receive either a high dose of psilocybin or methylphenidate

Who is the study for?
This trial is for individuals who have both chronic low back pain and depression. Participants will be given either a high dose of psilocybin or methylphenidate in a controlled setting, followed by assessments to track changes in their pain and mood.
What is being tested?
The study is testing the effects of a single high-dose of psilocybin (25mg) compared to methylphenidate (40mg) on chronic low back pain with co-existing depression. The focus is on how these substances affect pain mechanisms and depressive symptoms.
What are the potential side effects?
Possible side effects may include changes in sensory perception and mood, headaches, nausea, increased heart rate, blood pressure changes, dizziness, confusion or disorientation during the immediate period following dosing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post drug administration up to 8 hours, 1-week follow-up, 1-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and post drug administration up to 8 hours, 1-week follow-up, 1-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Changes in Pain Catastrophizing as assessed by the Pain Catastrophizing Scale and averaged over 7-day periods of Ecological Momentary Assessment (EMA)
Changes in Positive Affective Pain Inhibition (Quantitative Sensory Testing)
Changes in negative affect as assessed by discrete negative affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA)
+1 more
Other study objectives
Change in Emotion Regulation as assessed by the Difficulties in Emotion Regulation Scale (DERS)
Changes in CLBP-related disability as measured by the Oswestry Disability Index (ODI)
Changes in Conditioned Pain Modulation (Quantitative Sensory Testing)
+18 more

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PsilocybinExperimental Treatment1 Intervention
This arm will receive a single, absolute dose (25 mg) of psilocybin.
Group II: MethylphenidateActive Control1 Intervention
This arm will receive a single, absolute dose (40 mg) of methylphenidate.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~530

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,746 Total Patients Enrolled
57 Trials studying Depression
29,502 Patients Enrolled for Depression
National Center for Complementary and Integrative Health (NCCIH)NIH
866 Previous Clinical Trials
674,796 Total Patients Enrolled
65 Trials studying Depression
33,395 Patients Enrolled for Depression
David B Yaden, PhDPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
30 Total Patients Enrolled
~27 spots leftby Jul 2026
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