Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT06731335
Eligibility Criteria:
Inclusion Criteria:
* 18-65 years of age
* Diagnosis of chronic neuropathic pain as determined by a pain specialist
* Moderate-to-severe neuropathic pain determined by Patient Reported Outcomes Measurement Information System (PROMIS)
* Previous trials of at least two medications recommended in the Canadian consensus guidelines on the management of neuropathic pain with no self-reported meaningful improvement in symptoms
* Sufficient command of English to participate in psychotherapy
* For participants of childbearing potential, use of a highly effective or double-barrier methods of contraception.
Exclusion Criteria:
* History of Dextromethorphan addiction or abuse.
* Enzyme CYP2D6 deficient as shown on the pharmacogenetic test.
* Underlying psychiatric conditions: lifetime or family history of a primary psychotic disorder, bipolar disorder, borderline personality disorder, paranoid personality disorder, current suicidal ideation, and substance use disorder within the past 12 months as assessed by history and confirmed by the Mini International Neuropsychiatric Interview (MINI)
* Medications that interact with study drugs
* Medical condition that is unstable or inadequately controlled, including cardiovascular disease, liver disease, or end-stage renal disease
* Previous lifetime use of a serotonergic psychedelic drug
* Nursing or pregnant women.
* Any other clinically significant medical illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if they take part in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06731335
Study Brief:
Protocol Section:
NCT06731335