Status:
RECRUITING
Music as an Adjunct to Ketamine Therapy for Chronic Pain
Lead Sponsor:
McGill University
Collaborating Sponsors:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Chronic Pain
Chronic Noncancer Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Intravenous (IV) ketamine is a treatment option for patients with chronic pain that does not respond to standard therapies, primarily working by blocking NMDA receptors in the brain. Beyond pain relie...
Detailed Description
Chronic pain impacts nearly eight million Canadians, with many suffering from moderate to severe pain for over a decade. Traditional treatments often fail, prompting researchers to explore alternative...
Eligibility Criteria
Inclusion
- Diagnosis of chronic (3 months) pain of noncancerous origin, including chronic primary and secondary pain conditions, irrespective of its mechanistic contributors (nociceptive, neuropathic, or nociplastic), and of moderate to severe intensity (rated ≥ 4 in a 0-10 scale);
- Participants must have been prescribed IV ketamine treatment at the AEPMU, based on their treating clinician's assessment and judgment;
- Prior their participation in the study, all Participants must have undergone at least one ketamine IV session in the AEPMU clinical setting, which was well tolerated and did not reveal any important adverse effects, and which is expected to be repeated;
- Be able to use an electronic device (e.g., computer, tablet, smartphone) to complete questionnaires and diaries. For patients who may not possess such a device, a smartphone will be loaned for the duration of the study;
- No contraindication for intravenous ketamine treatment, including: poorly controlled cardiovascular disease, pregnancy or current or past history of psychosis, moderate to severe hepatic disease, elevated intracranial or extraocular pressure, and current or past history of substance abuse;
- Abstention from consuming grapefruit juice on the day of the ketamine infusions as it may alter the metabolism of ketamine;
Exclusion
- Low tolerability or ineffectiveness of previous intravenous treatment or ketamine infusions;
- Current diagnosis or treatment for cancer;
- Significant hearing impairment not improved with hearing aids and/or sound amplification or unwillingness to listen to music during treatment;
- Known intellectual disability or autism spectrum disorder;
- Known risk factors for intracranial hemorrhage, including previous significant trauma, known aneurysm, or previous neurosurgery;
- Evidence of clinically relevant disease, e.g., renal or hepatic impairment, significant coronary artery disease (myocardial infarct within a year prior to initial randomization), cerebrovascular disease, viral hepatitis B or C, acquired immunodeficiency syndrome or history of seizure disorder;
- Prior or current (i.e., past-year) history of substance use disorder (except for caffeine or nicotine use disorder) as defined by DSM-5 criteria;
- Acute psychotic or suicidal ideation symptoms, as judged by the referring clinician.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06994559
Start Date
June 1 2025
End Date
February 1 2028
Last Update
June 10 2025
Active Locations (1)
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1
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4