Music with ketamine infusions for chronic pain.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: mark.ware@mcgill.ca
• Phone: 1-5149348222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.