Recruiting

Ketamine with Music

Sponsor:

McGill University

Code:

NCT06994559

Conditions

Chronic Pain

Chronic Noncancer Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Preferred Music

Therapist-selected Music

Silence

Study Details

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.

Conditions

Chronic Pain

Chronic Noncancer Pain

Study ID

NCT06994559

Start date

Jun 1, 2025

Status verified date

Jun, 2025

Completion date

Feb 1, 2028

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Preferred-Therapist-Silence

Participants in this arm will be exposed to 1) Preferred music, 2) Therapist-selected music and 3) Silence in this order

other: Preferred-Silence-Therapist

Participants in this arm will be exposed to 1) Preferred music, 2) Silence, and 3) Therapist-selected music, in this order

other: Therapist-Preferred-Silence

Participants in this arm will be exposed to 1) Therapist-selected music, 2) Preferred music, 3) Silence, in this order

other: Therapist-Silence-Preferred

Participants in this arm will be exposed to 1) Therapist-selected music, 2) Silence, and 3) Preferred music, in this order

other: Silence-Therapist-Preferred

Participants in this arm will be exposed to 1) Silence, 2) Therapist-selected music, and 3) Preferred music, in this order

other: Silence-Preferred-Therapist

Participants in this arm will be exposed to 1) Silence, 2) Preferred music, and 3) Therapist-selected music, in this order

Interventions

Preferred Music

The self-selected preferred music intervention will expose participants to music chosen based on personal tastes. Patients will be instructed to compile a playlist lasting approximately 1 hour, but preferably over 1 hour (to avoid repetition or moments without music) of their favorite music. They will be instructed to select songs that they find extremely pleasurable to listen to. Participants will be instructed to select songs that will have a higher likelihood to facilitate relaxation and introspection. This does not need to be an all-time favorite selection, but rather the music that they currently enjoy listening to the most.

Therapist-selected Music

The therapist-selected music intervention will expose participants to a curated playlist specifically designed for psychedelic treatment by expert Music Therapists, which was used in a previous study to investigate the additive hemodynamic effects of music during ketamine infusions for depression. Patients will be randomly exposed to one of 9 available playlists, all containing songs without lyrics.

Silence

The silence intervention will expose patients to the same therapeutic procedures, in the same room and context, and with the same noise-cancelling headphones. The purpose is to cancel any potentially perturbing background noise, as no music will be played.

Primary outcome measure

  • Pain intensity [ Time Frame: From baseline to 24 hours after each ketamine session ]

Central Contacts and Locations

Central contacts

Mark A Ware, MD

1-5149348222mark.ware@mcgill.ca

Carlos Gevers-Montoro, PhD

carlos.geversmontoro@mcgill.ca

Locations

Montreal General Hospital

Recruiting

Montreal, Quebec, Canada, H3G 1A4

Contacts

Mark A Ware, MD

+1-5149348222mark.ware@mcgill.ca

More Information

Sponsor

McGill University

Last update posted

Jun 10, 2025

Last verified

Jun, 2025

Keywords

  • Chronic pain
  • Ketamine
  • Music

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University on 2025-06-10.