Clinical TrialChronic PainKetamineRecruiting

Music as an Adjunct to Ketamine Therapy for Chronic Pain (MusKiP)

This open-label, randomised crossover trial (n=25) will investigate the effects of intravenous (IV) ketamine (35 mg/70 kg; 0.5 mg/kg over 1 hour) combined with self-selected music, therapist-selected music, or silence on chronic noncancer pain.

Target Enrollment
25 participants
Study Type
Phase NA interventional
Design
Randomized

Detailed Description

Pragmatic randomised crossover trial recruiting 25 patients receiving repeated IV ketamine for chronic noncancer pain at the Alan Edwards Pain Management Unit. Each participant receives four one-hour infusions (baseline plus three conditions) of ketamine 0.5 mg/kg with randomized exposure to preferred music, therapist-selected music, or silence.

Outcomes include pain intensity and duration, mood, sleep, cognitive flexibility, and anxiety/depression symptoms; qualitative interviews will assess subjective ketamine experiences and any adverse effects. Sessions use noise-cancelling headphones and standardised ambient conditions to isolate music effects.

Study Protocol

Preparation

sessions

Dosing

4 sessions
60 min each

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Ketamine + music conditions

experimental

Randomised crossover of one baseline session and three music conditions (preferred music, therapist-selected music, silence) with IV ketamine 0.5 mg/kg over 60 minutes; four infusion sessions per participant in randomized order.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 4 doses total

    0.5 mg/kg IV over 60 minutes per session (four sessions per participant including baseline).

  • Compound
    via Other• per infusion

    Preferred music: participant-selected playlist ~1 hour delivered via noise-cancelling headphones.

  • Compound
    via Other• per infusion

    Therapist-selected music: curated lyric-free playlists used in prior psychedelic-therapy research.

  • Compound
    via Other• per infusion

    Silence: noise-cancelling headphones, no music; same ambience and procedures.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Diagnosis of chronic (3 months) pain of noncancerous origin, including chronic primary and secondary pain conditions, irrespective of mechanistic contributors, and of moderate to severe intensity (rated ≥ 4/10).
  • Participants must have been prescribed IV ketamine treatment at the AEPMU by their treating clinician.
  • Participants must have undergone at least one prior ketamine IV session in the AEPMU that was well tolerated without important adverse effects and is expected to be repeated.
  • Be able to use an electronic device (computer, tablet, smartphone) to complete questionnaires and diaries; a smartphone will be loaned if required.
  • No contraindication to IV ketamine (e.g., poorly controlled cardiovascular disease, pregnancy, current or past history of psychosis, moderate to severe hepatic disease, elevated intracranial or extraocular pressure, current or past history of substance abuse).
  • Abstain from grapefruit juice on the day of ketamine infusions.

Exclusion Criteria

  • Low tolerability or ineffectiveness of previous IV ketamine treatment.
  • Current diagnosis or treatment for cancer.
  • Significant hearing impairment not improved with hearing aids or unwillingness to listen to music during treatment.
  • Known intellectual disability or autism spectrum disorder.
  • Known risk factors for intracranial hemorrhage (previous significant trauma, known aneurysm, prior neurosurgery).
  • Clinically relevant disease (e.g., renal or hepatic impairment, significant coronary artery disease including MI within one year prior to randomisation, cerebrovascular disease, viral hepatitis B or C, AIDS, or history of seizure disorder).
  • Prior or current (past-year) substance use disorder (except caffeine or nicotine) per DSM-5.
  • Acute psychotic symptoms or suicidal ideation as judged by the referring clinician.

Study Details

  • Status
    Recruiting
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomized
  • Target Enrollment25 participants
  • Timeline
    Start: 2025-06-01
    End: 2028-02-01
  • Compound
    Ketamine
  • Topic
    Chronic Pain

Locations

Montreal General Hospital — Montreal, Quebec, Canada

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