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

Ketamine

Brief Summary

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 60 participants suffering from neuropathic chronic pain. Participants will be randomized to (1) Ketamine HL; (2) psychotherapy (using Cognitive Behavioral Therapy); or (3) a combination of Ketamine HL and psychotherapy.

Intervention / Treatment

  • 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.

Condition or Disease

  • Neuropathic Pain

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Not yet recruiting
    Study results: No Results Available
    Enrollment: 60 (ESTIMATED)
    Allocation: Randomized
    Primary Purpose: Other

    Masking

    SINGLE:
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jul 15, 2023 ESTIMATED
    Primary Completion: Jul 15, 2025 ESTIMATED
    Completion Date: Dec 15, 2026 ESTIMATED
    Study First Posted: Dec 06, 2022 ACTUAL
    Last Updated: Apr 25, 2023

    Sponsors / Collaborators

    Lead Sponsor: N/A
    Responsible Party: N/A

    Participant Groups

    • No description provided

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    1. ≥18 years of age
    2. 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
    3. 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
    4. Capacity to provide informed consent

    Exclusion Criteria:

    1. Patients less than 18 years of age
    2. Current or lifetime history of schizophrenia, psychotic disorder, bipolar disorder, or borderline personality disorder
    3. Known history of hypersensitivity or allergy to Ketamine-HCL
    4. Current history of dissociative disorders
    5. Current concomitant use of theophylline or aminophylline
    6. Current elevated intracranial pressure
    7. Pregnancy or ongoing breastfeeding in female participants
    8. Concomitant active substance use in the 6 months preceding enrolment (amphetamines, alcohol, and ketamine)
    9. 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 \[e.g. presence of dyspnea, peripheral edema, elevated jugular venous pressure, hepatomegaly, pulmonary rales, pleural effusions\])

    Primary Outcomes

    • Recruitment rate and withdrawal rate (Acceptability and feasibility study)

    • Feasibility

    • Safety and tolerability

    Secondary Outcomes

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

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

    More Details

    NCT Number: NCT05639322
    Other IDs: P-003
    Study URL: https://clinicaltrials.gov/study/NCT05639322
    Last updated: Sep 29, 2023