NCT06994559 Music as an Adjunct to Ketamine Therapy for Chronic Pain
| NCT ID | NCT06994559 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2025-06-01 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 relief, ketamine can produce dissociative sensations, classifying it as an atypical psychedelic or mind-altering drug, and may enable patients to reprocess their pain similarly to experiences with traditional psychedelics. At the Montreal General Hospital's pain clinic, the investigators have observed patients frequently listening to music during ketamine infusions, and recent research indicates that music-especially when self-selected by patients-might provide additional pain-relieving benefits by influencing central mechanisms related to pain perception and interpretation. This intersection of music and pain relief is garnering substantial scientific interest as recent advances provide more insight into the neuroscience of music and its effects on brain regions involved in emotion, sensation, memory, and pain. This study aims to investigate the effects of music on chronic pain patients undergoing IV ketamine infusions at the Alan Edwards Pain Management Unit (AEPMU), specifically to determine whether the choice of music affects the intensity and duration of ketamine-induced pain relief. During the infusion (lasting 1 hour), patients will listen to a playlist delivered through specialized headphones, which will either consist of their own selected music (preferred music), music chosen by a music therapist, or no music at all, in a randomized order. Patients will track their pain levels throughout the infusion period and in the intervals between treatments (5 weeks) using standardized pain assessment tools. Additionally, the investigators will assess the subjective experiences of ketamine through interviews and qualitative analysis, while documenting and summarizing any adverse effects. The investigators hypothesize that listening to preferred music will enhance both the intensity and duration of pain relief from IV ketamine. To test this, the investigators will recruit patients already receiving repeated IV ketamine infusions for pain management at the AEPMU clinic. The first infusion will take place under usual conditions to establish a baseline. The infusions will occur in a dedicated room equipped with audio technology to ensure an immersive music experience.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Mark A Ware, MD
PRINCIPAL INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Frequently Asked Questions
Who can join the NCT06994559 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06994559 currently recruiting?
Yes, NCT06994559 is actively recruiting participants. Contact the research team at mark.ware@mcgill.ca for enrollment information.
Where is the NCT06994559 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT06994559 clinical trial?
NCT06994559 is sponsored by McGill University. The principal investigator is Mark A Ware, MD at McGill University Health Centre/Research Institute of the McGill University Health Centre. The trial plans to enroll 25 participants.
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