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Stimulant

Psilocybin for 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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ post drug administration up to 8 hours, 1-week follow-up, 1-month follow-up

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

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 outcome measures

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

Nausea

Pain

Viral upper resp. tract infection

Back pain

Bronchitis

Suicidal Ideation

Oropharyngeal pain

Insomnia

Influenza

Depression

Diarrhea

Headache

Sinus headache

Depressed mood

Lower resp. tract congestion

Alcohol withdrawal syndrome

Restlessness

Fungal infection

Pyrexia

Oedema

Vomiting

Rhinorrhea

Musculoskeletal pain

Hypoesthesia

Peripheral swelling

Thrombocytosis

Eye infection

Constipation

Dermatitis contact

Bronchitis bacterial

Traumatic lung injury

Hyponatremia

Arthralgia

Pain in extremity

Dizziness

Migraine

Sedation

Anger

Anxiety

Cough

Sexual abuse

Sinus congestion

Malignant melanoma

Endodontic procedure

Mallory-Weiss Syndrom

Anemia

Influenza like Illness

Gingivitis

Arthoscopic surgery

100%

80%

60%

40%

20%

Study treatment Arm

Diphenhydramine

Psilocybin

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

~730

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,267 Previous Clinical Trials

14,837,567 Total Patients Enrolled

57 Trials studying Depression

29,575 Patients Enrolled for Depression

National Center for Complementary and Integrative Health (NCCIH)NIH

835 Previous Clinical Trials

669,500 Total Patients Enrolled

61 Trials studying Depression

32,875 Patients Enrolled for Depression

David B Yaden, PhDPrincipal InvestigatorJohns Hopkins University

1 Previous Clinical Trials

30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals older than thirty years being considered for enrollment in this research investigation?

"Eligible candidates for this research must fall within the age bracket of 21 to 65 years. It is noteworthy that there are a total of 235 investigations focusing on individuals under 18, and 1274 studies targeting those above 65 years old."

Answered by AI

Are there any available positions for participants in this research study?

"As indicated on clinicaltrials.gov, recruitment for this specific trial is not currently ongoing. The trial was first listed on 4/1/2024 and last revised on 4/4/2024. Despite the current inactivity of this particular study, it's noteworthy that there are a total of 1737 other trials available for patient enrollment at present."

Answered by AI

What are the potential risks of Psilocybin for individuals undergoing treatment?

"The safety rating for Psilocybin is perceived to be 1 according to the Power team, as this trial falls under Phase 1 where there is restricted evidence backing its safety and effectiveness."

Answered by AI

Recent research and studies

Journal of PsychopharmacologyJournal

Validation of the Revised Mystical Experience Questionnaire in Experimental Sessions with Psilocybin

Barrett, Frederick S, Matthew W Johnson, and Roland R Griffiths. 2015. “Validation of the Revised Mystical Experience Questionnaire in Experimental Sessions with Psilocybin”. Journal of Psychopharmacology. SAGE Publications. doi:10.1177/0269881115609019.

The Journal of PainJournal

Reciprocal Relationship Between Pain and Depression: A 12-month Longitudinal Analysis in Primary Care

Kroenke, Kurt, Jingwei Wu, Matthew J. Bair, Erin E. Krebs, Teresa M. Damush, and Wanzhu Tu. 2011. “Reciprocal Relationship Between Pain and Depression: A 12-month Longitudinal Analysis in Primary Care”. The Journal of Pain. Elsevier BV. doi:10.1016/j.jpain.2011.03.003.

Journal of General Internal MedicineJournal

Development and Initial Validation of the PEG, a Three-item Scale Assessing Pain Intensity and Interference

Krebs, Erin E., Karl A. Lorenz, Matthew J. Bair, Teresa M. Damush, Jingwei Wu, Jason M. Sutherland, Steven M. Asch, and Kurt Kroenke. 2009. “Development and Initial Validation of the PEG, a Three-item Scale Assessing Pain Intensity and Interference”. Journal of General Internal Medicine. Springer Science and Business Media LLC. doi:10.1007/s11606-009-0981-1.

clinicaltrials.govStudy