Music with ketamine infusions for chronic pain.

Investigating the Synergistic Potential of Music as an Adjunct to Ketamine Therapy for Chronic Noncancer Pain

We will test whether listening to self-selected or therapist-selected music during IV ketamine infusions helps people with chronic noncancer pain feel less pain.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: McGill University (Academic / other)
• Locations: 1 site (Montreal, Quebec)
• Trial ID: NCT06994559 on ClinicalTrials.gov

What this trial studies

This pragmatic randomized crossover trial will enroll 25 patients at the Alan Edwards Pain Management Unit who are already prescribed IV ketamine. Each participant will receive four one-hour 0.5 mg/kg ketamine infusions in a controlled setting, crossing through conditions of self-selected music, therapist-selected music, silence, and a baseline control. Sessions use noise-cancelling headphones and dim lighting and participants create playlists beforehand to standardize the music condition. Pain and related outcomes will be recorded before, during, and after each infusion to compare the immediate effects of the different auditory conditions.

Who should consider this trial

Good fit: Adults with chronic noncancer pain (≥3 months) who have been prescribed and previously tolerated IV ketamine at the AEPMU, report moderate to severe pain (≥4/10), and can use or be provided an electronic device are eligible.

Not a fit: Patients with contraindications to IV ketamine, those who cannot tolerate ketamine infusions, or those receiving treatment for cancer-related pain are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding patient-selected music to ketamine infusions could increase pain relief and improve the infusion experience with minimal extra risk.

How similar studies have performed: Prior research shows music can modulate pain perception and enhance psychedelic-assisted therapy experiences, but combining self-selected music with ketamine for chronic pain is relatively novel with limited direct trial data.

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.

Where this trial is running

Montreal, Quebec

• Montreal General Hospital — Montreal, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Mark A Ware, MD — McGill University Health Centre/Research Institute of the McGill University Health Centre
• Study coordinator: Mark A Ware, MD

Conditions Chronic Pain; Chronic Noncancer Pain; Chronic pain; Ketamine; Music