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Completed

NCT Number: NCT05639322

Psychotherapy for Ketamine's Enhanced Durability in Chronic Neuropathic Pain: A Randomized Controlled Pilot Trial

The purpose of the study is to investigate new therapies to alleviate pain on neuropathic chronic pain. At this time, the main purpose is to complete a feasibility or pilot study with 30 participants suffering from neuropathic chronic pain. Participants will be randomized to (1) Ketamine (Hydrochloride) HCL; (2) psychotherapy (using Cognitive Behavioral Therapy); or (3) a combination of Ketamine HL and psychotherapy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years of age
  • Diagnosis of chronic neuropathic pain as determined by a pain specialist with moderate-to-severe neuropathic pain as per ID pain questionnaire, with mean pain scores > 3 on a numeric rating scale (NRS), in the 7 days preceding inclusion
  • For participants of childbearing potential, use highly effective or double-barrier methods of contraception. Abstinence is acceptable if it is the preferred and usual lifestyle of the participant
  • Capacity to provide informed consent

Exclusion criteria

  • Patients less than 18 years of age
  • Current or lifetime history of schizophrenia, psychotic disorder, bipolar disorder, or borderline personality disorder
  • Known history of hypersensitivity or allergy to Ketamine-HCL
  • Current history of dissociative disorders
  • Current concomitant use of theophylline or aminophylline
  • Current elevated intracranial pressure
  • Pregnancy or ongoing breastfeeding in female participants
  • Concomitant active substance use in the 6 months preceding enrolment (amphetamines, alcohol, and ketamine)
  • Contraindication to receiving Ketamine-HCL (e.g. current or lifetime history of cerebrovascular accident; current significant hypertension [systolic blood pressure higher than 160 mmHg and/or diastolic blood pressure higher than 100 mmHg]; current severe cardiac decompensation [e.g. presence of dyspnea, peripheral edema, elevated jugular venous pressure, hepatomegaly, pulmonary rales, pleural effusions])

Treatment and study plan

Ketamine Hydrochloride

Drug

Ketamine-HCL IV 1mg/kg (up to 100 mg) over 2 hours, on weeks 2, 7, and 12.

Cognitive behavioral therapy

Behavioral

Cognitive Behavioural Therapy/ Mindfulness Based Meditation therapy (CBT/MM) remotely for 16 hours between weeks 1 to 16 inclusive + in-person sessions on weeks 2, 7 and 12

Ketamine + Cognitive Behavioral Therapy

Other

Ketamine-HCL + CBT/MM according to the same directions specified in Arm 1 and Arm 2.

Primary outcomes

  1. Recruitment rate

    Time frame: 2 years

    Recruitment rate and withdrawal rate (Acceptability and feasibility study)

  2. Adherence rate

    Time frame: 2 years

    Feasibility

  3. Frequency of adverse events

    Time frame: 2 years

    Safety and tolerability

Secondary outcomes

  1. Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS) Pain Intensity, 1 a.

    Time frame: 20 weeks

    PROMIS-PI - 1 a. pain intensity scale- 0 to 10 (The higher the number the higher the pain intensity)

  2. Patient-Reported Outcomes Measurement Information System Pain Interference, PROMIS 6 a. Pain Interference,

    Time frame: 20 weeks

    PROMIS-PI -Short form 6 a. - pain interference scale- 6 items, 5 likert scale The higher the score the higher the interference from pain)

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Acronym: PSYKED-NP

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2022
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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