Fibromyalgia, PrimaryEarly Phase 1NCT05068791
Psilocybin-facilitated Treatment for Chronic Pain
A Early Phase 1 study testing Psilocybin and Dextromethorphan in people with Fibromyalgia, Primary, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The primary purpose of this study is to preliminarily estimate the efficacy of psilocybin-facilitated treatment for fibromyalgia. Investigators will assess the impact of psilocybin-facilitated treatment on pain, fatigue, and other fibromyalgia symptoms, in addition to the level of functioning and quality of life. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Fibromyalgia, Primary
- What is being tested?
- Psilocybin and Dextromethorphan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female age 25-65;
- Widespread musculoskeletal pain for ≥12 months;
- Symptoms meeting the American College of Rheumatology (ACR) 2016 revisions to the 2010/2011 Fibromyalgia Diagnostic Criteria;
- Participant completes daily report during baseline period (at least 80% completion rate);
- Able to attend UAB for all scheduled appointments;
- Ability to read/write in English;
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- No prior hallucinogen use or it will have been at least 3 years since last use of a hallucinogen;
- Availability of a friend or family member into whose care the participant can be released (a key responsibility includes driving participants home) following their drug administration session;
- A current average daily pain score of at least 5 on a 0-10 scale;
- Discontinuation of exclusionary medication occurring at least two weeks and for at least 5 half-lives, whichever is longer, prior to drug administration day.
Who cannot join
- Males;
- Use of opioid medications in the last 60 days;
- Regular use of any anti-inflammatory medication (e.g., aspirin, ibuprofen, naproxen);
- Use of blood thinning medication;
- Use of tricyclic antidepressants, lithium, SSRIs, MAOIs, St. John's Wort, 5-hydroxytryptophan (5-HT), haloperidol, or other antipsychotic medications, mood stabilizers, or medications with serotonin activity;
- Daily consumption of grapefruit juice;
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- Febrile illness or use of antibiotics in the 4 weeks before study commencement;
- Planned surgery or procedures during the study period, or operated on in the 4 weeks prior to study commencement;
- Planning to move from the Birmingham area in the next 6 months;
- Planned vaccination during the study period, or vaccinated in the 4 weeks before study commencement;
- Current participation in another treatment trial;
- Pregnant or planning to become pregnant within 6 months, or currently breastfeeding;
- Significant psychological comorbidity that in the discretion of the investigator compromises study integrity (i.e., presence of a current, clinically significant, untreated or unstable psychiatric condition) and/or a baseline HADS depression subscale score of ≥16;
- Current or past history of any psychotic disorders;
- Current or past history of bipolar I or II disorder;
- First or second-degree relatives with any psychotic disorders, or bipolar I or II disorders;
- Current suicidal or homicidal ideation (assessed using Columbia-Suicide Severity Rating Scale at each visit);
- Diagnosed rheumatologic or auto-immune condition;
- Blood or clotting disorder;
- Current hypertension (exceeding 140 systolic or 90 diastolic at resting); resting heart rate>90
- Acute infection (oral temperature >100°F);
- High-sensitivity c-reactive protein (hs-CRP) ≥ 10mg/L;
- Erythrocyte sedimentation rate (ESR) > 60 mm/hr;
- Positive rheumatoid factor;
- Positive anti-nuclear antibody (ANA);
- Levels of thyroid-stimulating hormone or free thyroxine outside UAB Hospital Labs reference values;
- Use of UGT1A9, UGT1A10 and aldehyde or alcohol dehydrogenase enzyme inhibitors;
- Dependent on any psychoactive drugs other than nicotine and caffeine;
- Use of the antiviral drug efavirenz;
- Use of PDE-5-Inhibitors, soluble guanylate cyclase (sGC) stimulators;
- Severe anemia;
- Phenylketonuria, chronic bronchitis, emphysema, asthma, diabetes, liver disease, and mucus with cough or slowed breathing
- Use of any medication containing dextromethorphan (e.g., cough suppressants);
- Pain due to other conditions or diseases that would complicate study participation or pain reporting.
- Use of strong or moderate inhibitors of Cytochrome P450 2D6 (CYP2D6)
- Poor metabolizers of CYP2D6 based on genotype
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UAB Beacon Tower
Birmingham, Alabama, 35209
Peter Hendricks, PhD, pshendricks@uabmc.edu
About this study
The primary purpose of this study is to preliminarily estimate the efficacy of psilocybin-facilitated treatment for fibromyalgia. Investigators will assess the impact of psilocybin-facilitated treatment on pain, fatigue, and other fibromyalgia symptoms, in addition to the level of functioning and quality of life. Investigators will also evaluate potential mediators of treatment (e.g., treatment expectations, pain characteristics, personality, beliefs/cognitions, emotions). Investigators hypothesize psilocybin treatment will significantly reduce symptom severity in fibromyalgia patients.
Read the detailed description
Participants will be randomized to two groups: Psilocybin or Active Placebo. Those in the Psilocybin condition will receive .36 mg/kg of psilocybin. Based on previous research, .36 mg/kg of psilocybin is expected to balance the intention to increase the probability of having a full mystical-type experience against the odds of having a subjectively challenging psychological experience. Those in the Active Placebo condition will receive 2.6 mg/kg of dextromethorphan (DXM). DXM was selected as the placebo drug in the current study because its subjective and behavioral effects at higher doses can resemble those of classical hallucinogens. Participants will be blinded to what drug they are administered. Participants will be unblinded at the end of the study. Participants will attend between 7 to 9 study sessions to complete the protocol.
Interested individuals who call research staff will undergo an initial telephone prescreen by a trained member of the research staff: the study aims, protocol, and any possible risks will be described and a series of questions will be asked to determine interest and eligibility for screening for the study. Initial eligibility may also be assessed via an online questionnaire through Qualtrics. Qualified participants will be scheduled for an in-person screening.
In-person screening sessions will be conducted by the PI or trained research staff. Individuals will first undergo informed consent; the consent form will describe the necessary eligibility confirmation that takes place before proceeding with the full study. A physical examination, a detailed psychiatric interview, several self-report questionnaires, and a detailed medical history will be completed at the screening session, which takes place at the UAB Clinical Research Unit. Participants will also have their blood drawn for screening tests. Study staff will provide participants with a hand-held tablet device and instructions on how to complete the daily symptom questionnaire via the tablet. They will be asked to begin reporting daily symptoms on their tablet from home that evening.
Eligible participants will be contacted by study staff by phone to inform them of their eligibility.
All participants will undergo at least 2 weekly preparation sessions of approximately 2 hours each, with the possibility of 1-2 additional weekly preparatory sessions per the discretion of the investigator. These sessions are to educate participants on the study protocol, psilocybin administration, and study treatment rationale. Participants will be randomly assigned in a double-blind manner to the Psilocybin or Active Placebo group following their final preparation session.
One week after the final preparation session, participants will be instructed to eat a low-fat breakfast prior to presenting for their drug administration session at 8:00 am, approximately 1 hour before drug administration. A urine sample will be collected to verify drug-free and non-pregnant status and participants will be encouraged to relax and reflect before drug administration. The drug administration session will take place over the course of 8 hours. The guide and secondary monitor will be present with and monitor participants throughout this session (at least one individual will always be present with the participant, even during brief intervals when the guide or monitor may be using the restroom). Participants will be monitored for physical symptoms of distress and encouraged to report any symptoms experienced. Blood pressure will be assessed pre-administration via automatic blood pressure monitor, and will also be assessed at 30, 60, 90, 120, 180, 240, 300, and 360 minutes post-administration.
Eight hours after drug administration, when the major drug effects have subsided, participants will complete questionnaires assessing their experience. Participants will then be released into the care of a friend or family member oriented to be emotionally supportive of the participant (as arranged during preparation sessions) and instructed not to drive an automobile or engage in any other potentially dangerous activity for the remainder of the day. Participants will be provided with the guide's contact information by phone should they feel the need for support that evening.
An immediate post-session meeting will be held the day following the drug administration session. Participants will meet with the guide for approximately 2 hours to discuss and reflect on their experience.
A final study visit will take place approximately 6 weeks later; some questionnaires that were administered at Visit 1 will be administered again at the final visit. At the conclusion of the final study visit, participants will be debriefed.
- Conditions
- Fibromyalgia, Primary
- Being tested
- Psilocybin, Dextromethorphan
- Keywords
- psilocybin, fibromyalgia, pain
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
0.36 mg/kg will be administered orally to participants
DextromethorphanDrug
2.6 mg/kg of active placebo will be administered orally to participants
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin | Experimental | Participants in the Psilocybin condition will receive .36 mg/kg of psilocybin. Receives: Drug: Psilocybin |
| Active Placebo | Active comparator | Participants in the Active Placebo condition will receive 2.6 mg/kg of dextromethorphan (DXM). Receives: Drug: Dextromethorphan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daily self-reported pain severity
Daily pain severity will be measured using a visual analog scale rated from 0 ('no pain at all') to 100 ('severe pain')
Measured: through study completion, up to 13 weeks
Secondary outcomes (3)
Patient Global Impression of Change (PGIC)
The PGIC is a single-item Likert scale with seven response options from 1 ('very much improved') to 7 ('very much worse').
Measured: through study completion, up to 13 weeks
Change in self-reported pain severity (Brief Pain Inventory [BPI])
Pain severity scores will be calculated as a composite of the four pain severity items scored from 0 ('no pain') to 10 ('pain as bad as you can imagine') on the BPI
Measured: through study completion, up to 13 weeks
Change in self-reported pain interference (Brief Pain Inventory [BPI])
Pain interference scores will be calculated as the mean of the seven pain interference items scored from 0 ('does not interfere') to 10 ('completely interferes') on the BPI.
Measured: through study completion, up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia, PrimaryStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-blind, placebo- controlled clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Hendricks, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068791
- Sponsor's protocol ID
- IRB-300006769
- Other IDs
- UAB
- Status last verified
- Mar 2026
- First submitted
- 8 Sep 2021
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin-facilitated Treatment for Chronic Pain
- ClinicalTrials.gov ID
- NCT05068791
- Acronym / sponsor ID
- IRB-300006769
- Conditions
- Fibromyalgia, Primary
- Keywords
- psilocybin, fibromyalgia, pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to preliminarily estimate the efficacy of psilocybin-facilitated treatment for fibromyalgia. Investigators will assess the impact of psilocybin-facilitated treatment on pain, fatigue, and other fibromyalgia symptoms, in addition to the level of functioning and quality of life. Investigators will also evaluate potential mediators of treatment (e.g., treatment expectations, pain characteristics, personality, beliefs/cognitions, emotions). Investigators hypothesize psilocybin treatment will significantly reduce symptom severity in fibromyalgia patients.
Detailed description
Participants will be randomized to two groups: Psilocybin or Active Placebo. Those in the Psilocybin condition will receive .36 mg/kg of psilocybin. Based on previous research, .36 mg/kg of psilocybin is expected to balance the intention to increase the probability of having a full mystical-type experience against the odds of having a subjectively challenging psychological experience. Those in the Active Placebo condition will receive 2.6 mg/kg of dextromethorphan (DXM). DXM was selected as the placebo drug in the current study because its subjective and behavioral effects at higher doses can resemble those of classical hallucinogens. Participants will be blinded to what drug they are administered. Participants will be unblinded at the end of the study. Participants will attend between 7 to 9 study sessions to complete the protocol.
Interested individuals who call research staff will undergo an initial telephone prescreen by a trained member of the research staff: the study aims, protocol, and any possible risks will be described and a series of questions will be asked to determine interest and eligibility for screening for the study. Initial eligibility may also be assessed via an online questionnaire through Qualtrics. Qualified participants will be scheduled for an in-person screening.
In-person screening sessions will be conducted by the PI or trained research staff. Individuals will first undergo informed consent; the consent form will describe the necessary eligibility confirmation that takes place before proceeding with the full study. A physical examination, a detailed psychiatric interview, several self-report questionnaires, and a detailed medical history will be completed at the screening session, which takes place at the UAB Clinical Research Unit. Participants will also have their blood drawn for screening tests. Study staff will provide participants with a hand-held tablet device and instructions on how to complete the daily symptom questionnaire via the tablet. They will be asked to begin reporting daily symptoms on their tablet from home that evening.
Eligible participants will be contacted by study staff by phone to inform them of their eligibility.
All participants will undergo at least 2 weekly preparation sessions of approximately 2 hours each, with the possibility of 1-2 additional weekly preparatory sessions per the discretion of the investigator. These sessions are to educate participants on the study protocol, psilocybin administration, and study treatment rationale. Participants will be randomly assigned in a double-blind manner to the Psilocybin or Active Placebo group following their final preparation session.
One week after the final preparation session, participants will be instructed to eat a low-fat breakfast prior to presenting for their drug administration session at 8:00 am, approximately 1 hour before drug administration. A urine sample will be collected to verify drug-free and non-pregnant status and participants will be encouraged to relax and reflect before drug administration. The drug administration session will take place over the course of 8 hours. The guide and secondary monitor will be present with and monitor participants throughout this session (at least one individual will always be present with the participant, even during brief intervals when the guide or monitor may be using the restroom). Participants will be monitored for physical symptoms of distress and encouraged to report any symptoms experienced. Blood pressure will be assessed pre-administration via automatic blood pressure monitor, and will also be assessed at 30, 60, 90, 120, 180, 240, 300, and 360 minutes post-administration.
Eight hours after drug administration, when the major drug effects have subsided, participants will complete questionnaires assessing their experience. Participants will then be released into the care of a friend or family member oriented to be emotionally supportive of the participant (as arranged during preparation sessions) and instructed not to drive an automobile or engage in any other potentially dangerous activity for the remainder of the day. Participants will be provided with the guide's contact information by phone should they feel the need for support that evening.
An immediate post-session meeting will be held the day following the drug administration session. Participants will meet with the guide for approximately 2 hours to discuss and reflect on their experience.
A final study visit will take place approximately 6 weeks later; some questionnaires that were administered at Visit 1 will be administered again at the final visit. At the conclusion of the final study visit, participants will be debriefed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a double-blind, placebo- controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Psilocybin | Experimental | Drug: PsilocybinParticipants in the Psilocybin condition will receive .36 mg/kg of psilocybin. |
| Active Placebo | Active comparator | Drug: DextromethorphanParticipants in the Active Placebo condition will receive 2.6 mg/kg of dextromethorphan (DXM). |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female age 25-65;
- Widespread musculoskeletal pain for ≥12 months;
- Symptoms meeting the American College of Rheumatology (ACR) 2016 revisions to the 2010/2011 Fibromyalgia Diagnostic Criteria;
- Participant completes daily report during baseline period (at least 80% completion rate);
- Able to attend UAB for all scheduled appointments;
Key exclusion criteria (36 listed)
- Males;
- Use of opioid medications in the last 60 days;
- Regular use of any anti-inflammatory medication (e.g., aspirin, ibuprofen, naproxen);
- Use of blood thinning medication;
- Use of tricyclic antidepressants, lithium, SSRIs, MAOIs, St. John's Wort, 5-hydroxytryptophan (5-HT), haloperidol, or other antipsychotic medications, mood stabilizers, or medications with serotonin activity;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin0.36 mg/kg will be administered orally to participants | Drug | Psilocybin |
| Dextromethorphan2.6 mg/kg of active placebo will be administered orally to participants | Drug | Active Placebo |
Primary outcome
Change in daily self-reported pain severity
Time frame: through study completion, up to 13 weeks
Daily pain severity will be measured using a visual analog scale rated from 0 ('no pain at all') to 100 ('severe pain')
3 secondary outcomes
Patient Global Impression of Change (PGIC)
Time frame: through study completion, up to 13 weeks
Change in self-reported pain severity (Brief Pain Inventory [BPI])
Time frame: through study completion, up to 13 weeks
Change in self-reported pain interference (Brief Pain Inventory [BPI])
Time frame: through study completion, up to 13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Psilocybin and Dextromethorphan in people with Fibromyalgia, Primary, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Hendricks, Ph.D. (205-202-1387, phendricks@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daily self-reported pain severity (time frame: through study completion, up to 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.