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Psychedelic

Psilocybin for Fibromyalgia

Q: Does this research permit the participation of individuals over fifty years of age?

Within the confines of this scientific research, recruitment is open to individuals that are between 25 and 65 years old.

Q: Is it still possible to become part of this research project?

This trial is searching for 30 individuals with <a href="https://www.withpower.com/clinical-trials/fibromyalgia">fibromyalgia</a> between the ages of 25 and 65. Essential criteria include being female, having had musculoskeletal <a href="https://www.withpower.com/clinical-trials/pain">pain</a> longer than 12 months that meets American College of Rheumatology's 2016 diagnostic parameters, completing daily report during baseline period (at least 80% completion rate), able to attend University of <a href="https://www.withpower.com/clinical-trials/alabama">Alabama</a> at Birmingham appointments, reading/writing English literacy, absence or 3 year interval since last hallucinogen use if any prior usage occurred, availability of companion post-treatment drug administration session who can drive home participant after treatment as well as an average daily pain score no less than 5 on a

Q: Are there any vacant slots available for prospective trial participants?

Confirmed. Clinicaltrials.gov verifies that this research project, initially posted on November 1st 2023, is actively recruiting volunteers to participate. The trial requires 30 individuals from a single clinical site.

Q: What is the current extent of enrollment in this trial?

Affirmative. The information on clinicaltrials.gov reveals that this medical research is currently in search of participants, with the initial posting dating back to November 1st 2023 and last update taking place December 7th 2023. 30 individuals are required for this investigation at a single location.

Phase < 1

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female age 25-65;

Widespread musculoskeletal pain for ≥12 months;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 13 weeks

Awards & highlights

Study Summary

This trial aims to study the effect of psilocybin-facilitated treatment on fibromyalgia symptoms, functioning, and quality of life. It will also explore possible causes of the treatment's effects.

Who is the study for?

This trial is for women aged 25-65 with chronic pain conditions like fibromyalgia, meeting specific diagnostic criteria. Participants must have had widespread musculoskeletal pain for over a year and report an average daily pain score of at least 5 out of 10. They should be able to attend all appointments, read/write in English, not have used hallucinogens recently (or at least not in the past three years), and have someone to drive them home after treatment sessions.Check my eligibility

What is being tested?

The study is testing if psilocybin can help reduce symptoms of fibromyalgia such as pain and fatigue. It will compare the effects of psilocybin-facilitated treatment against dextromethorphan to see which one improves patients' quality of life and functioning better.See study design

What are the potential side effects?

Psilocybin may cause psychological effects like altered perception, mood changes, or anxiety during treatment. Physical side effects could include nausea or headaches. Dextromethorphan might also lead to dizziness, sleepiness, or gastrointestinal disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged between 25 and 65.

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I have had widespread body pain for at least 12 months.

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I have been diagnosed with fibromyalgia according to the latest criteria.

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My daily pain level averages at least 5 out of 10.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 13 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 13 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 13 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in daily self-reported pain severity

Secondary outcome measures

Change in self-reported pain interference (Brief Pain Inventory [BPI])

Change in self-reported pain severity (Brief Pain Inventory [BPI])

Patient Global Impression of Change (PGIC)

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

Rhinorrhea

Pyrexia

Oedema

Vomiting

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

Participants in the Psilocybin condition will receive .36 mg/kg of psilocybin.

Group II: Active PlaceboActive Control1 Intervention

Participants in the Active Placebo condition will receive 2.6 mg/kg of dextromethorphan (DXM).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

2021

Completed Phase 2

~730

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,632 Total Patients Enrolled

6 Trials studying Fibromyalgia

40,312 Patients Enrolled for Fibromyalgia

Frequently Asked Questions

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

Does this research permit the participation of individuals over fifty years of age?

"Within the confines of this scientific research, recruitment is open to individuals that are between 25 and 65 years old."

Answered by AI

Is it still possible to become part of this research project?

"This trial is searching for 30 individuals with fibromyalgia between the ages of 25 and 65. Essential criteria include being female, having had musculoskeletal pain longer than 12 months that meets American College of Rheumatology's 2016 diagnostic parameters, completing daily report during baseline period (at least 80% completion rate), able to attend University of Alabama at Birmingham appointments, reading/writing English literacy, absence or 3 year interval since last hallucinogen use if any prior usage occurred, availability of companion post-treatment drug administration session who can drive home participant after treatment as well as an average daily pain score no less than 5 on a"

Answered by AI

Are there any vacant slots available for prospective trial participants?

"Confirmed. Clinicaltrials.gov verifies that this research project, initially posted on November 1st 2023, is actively recruiting volunteers to participate. The trial requires 30 individuals from a single clinical site."

Answered by AI

What is the current extent of enrollment in this trial?

"Affirmative. The information on clinicaltrials.gov reveals that this medical research is currently in search of participants, with the initial posting dating back to November 1st 2023 and last update taking place December 7th 2023. 30 individuals are required for this investigation at a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Psilocybin-facilitated Treatment for Chronic Pain

Peter Hendricks 2023. "Psilocybin-facilitated Treatment for Chronic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05068791.