Early Phase 1 Fibromyalgia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are a woman between the ages of 25 and 65
• You have had widespread pain throughout your body for at least 12 months
• You have been diagnosed with fibromyalgia based on the 2016 American College of Rheumatology criteria
• You are willing and able to fill in a daily report during the early part of the study (completing at least 80% of the entries)
• You are able to travel to UAB (University of Alabama at Birmingham) for all scheduled visits
• You can read and write in English
• You have never used hallucinogens, or your last use was at least 3 years ago
• You have a trusted friend or family member who can accompany you and drive you home after the medication session
• Your average daily pain level is at least 5 out of 10
• If you are currently taking any medications that are not allowed in the study, you are willing to stop them for a set period of time before the study begins (confirm with trial site for details)

Who may not be able to join:

• You are male
• You have used opioid pain medications (such as codeine or oxycodone) in the last 60 days
• You regularly take anti-inflammatory medications such as aspirin, ibuprofen, or naproxen
• You take blood-thinning medications
• You currently take certain antidepressants, mood stabilizers, antipsychotics, lithium, St. John's Wort, or other medications that affect serotonin levels (confirm with trial site for the full list)
• You drink grapefruit juice every day
• You have had a fever or taken antibiotics in the 4 weeks before the study starts
• You have had surgery recently or are planning surgery during the study period
• You are planning to move away from the Birmingham area within the next 6 months
• You have had a vaccination recently or are planning one during the study period
• You are currently taking part in another treatment trial
• You are pregnant, planning to become pregnant within 6 months, or currently breastfeeding
• You have a significant untreated or unstable mental health condition, or you scored highly on a depression screening questionnaire (confirm with trial site)
• You have a current or past history of any psychotic disorder (such as schizophrenia)
• You have a current or past history of bipolar disorder (type I or II)
• A parent, sibling, or child of yours has had a psychotic disorder or bipolar disorder
• You are currently having thoughts of harming yourself or others
• You have been diagnosed with a rheumatological or autoimmune condition (such as lupus or rheumatoid arthritis)
• You have a blood or clotting disorder
• You have high blood pressure or a resting heart rate above 90 beats per minute
• You currently have an active infection with a fever
• Certain blood test results are outside acceptable ranges, including markers of inflammation, thyroid levels, or signs of autoimmune activity (confirm with trial site)
• You are dependent on any mind-altering substances other than nicotine or caffeine
• You take the antiviral medication efavirenz
• You take certain medications used for erectile dysfunction or related conditions (confirm with trial site)
• You have severe anaemia
• You have certain health conditions including phenylketonuria, chronic bronchitis, emphysema, asthma, diabetes, liver disease, or a persistent cough with mucus or breathing difficulties
• You use any medication containing dextromethorphan (found in some cough medicines)
• Your pain is primarily caused by a condition other than fibromyalgia
• You take certain medications that affect how the body processes drugs (known as CYP2D6 inhibitors, confirm with trial site)
• Based on genetic testing, your body processes a certain enzyme (CYP2D6) more slowly than average (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.