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Psychotherapy for Ketamine's Enhanced Durability in Chronic Neuropathic Pain: A Randomized Controlled Pilot Trial (PSYKED-NP)

Primary Purpose

Neuropathic Pain

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ketamine Hydrochloride
Cognitive Behavioral Therapy
Ketamine + Cognitive Behavioral Therapy
Sponsored by
Akash Goel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neuropathic Pain focused on measuring Feasibility trial, Keteamine, Cognitive behavioural therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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])

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Experimental

    Arm Label

    Ketamine only

    Psychotherapy only

    Ketamine + Psychotherapy

    Arm Description

    Outcomes

    Primary Outcome Measures

    Recruitment rate
    Recruitment rate and withdrawal rate (Acceptability and feasibility study)
    Adherence rate
    Feasibility
    Frequency of adverse events
    Safety and tolerability

    Secondary Outcome Measures

    Patient-Reported Outcomes Measurement Information System Pain Interference, PROMIS Pain Intensity, 1 a.
    PROMIS-PI - 1 a. pain intensity scale- 0 to 10 (The higher the number the higher the pain intensity)
    Patient-Reported Outcomes Measurement Information System Pain Interference, PROMIS 6 a. Pain Interference,
    PROMIS-PI -Short form 6 a. - pain interference scale- 6 items, 5 likert scale The higher the score the higher the interference from pain)

    Full Information

    First Posted
    November 28, 2022
    Last Updated
    April 25, 2023
    Sponsor
    Akash Goel
    Collaborators
    Unity Health Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05639322
    Brief Title
    Psychotherapy for Ketamine's Enhanced Durability in Chronic Neuropathic Pain: A Randomized Controlled Pilot Trial
    Acronym
    PSYKED-NP
    Official Title
    Psychotherapy for Ketamine's Enhanced Durability in Chronic Neuropathic Pain: A Randomized Controlled Pilot Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 15, 2023 (Anticipated)
    Primary Completion Date
    July 15, 2025 (Anticipated)
    Study Completion Date
    December 15, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Akash Goel
    Collaborators
    Unity Health Toronto

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neuropathic Pain
    Keywords
    Feasibility trial, Keteamine, Cognitive behavioural therapy

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ketamine only
    Arm Type
    Active Comparator
    Arm Title
    Psychotherapy only
    Arm Type
    Active Comparator
    Arm Title
    Ketamine + Psychotherapy
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Ketamine Hydrochloride
    Intervention Description
    Ketamine-HCL IV 1mg/kg (up to 100 mg) over 2 hours, on weeks 2, 7, and 12.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive Behavioral Therapy
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Ketamine + Cognitive Behavioral Therapy
    Intervention Description
    Ketamine-HCL + CBT/MM according to the same directions specified in Arm 1 and Arm 2.
    Primary Outcome Measure Information:
    Title
    Recruitment rate
    Description
    Recruitment rate and withdrawal rate (Acceptability and feasibility study)
    Time Frame
    2 years
    Title
    Adherence rate
    Description
    Feasibility
    Time Frame
    2 years
    Title
    Frequency of adverse events
    Description
    Safety and tolerability
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Patient-Reported Outcomes Measurement Information System Pain Interference, PROMIS Pain Intensity, 1 a.
    Description
    PROMIS-PI - 1 a. pain intensity scale- 0 to 10 (The higher the number the higher the pain intensity)
    Time Frame
    20 weeks
    Title
    Patient-Reported Outcomes Measurement Information System Pain Interference, PROMIS 6 a. Pain Interference,
    Description
    PROMIS-PI -Short form 6 a. - pain interference scale- 6 items, 5 likert scale The higher the score the higher the interference from pain)
    Time Frame
    20 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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])
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Akash Goel, MD
    Phone
    416-864-5825
    Email
    Akash.Goel@unityhealth.to
    First Name & Middle Initial & Last Name or Official Title & Degree
    Janneth Pazmino-Canizares, MSc
    Phone
    416-864-6060
    Ext
    49561
    Email
    Janneth.Pazmino-Canizares@unityhealth.to

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No individual participant data has been planned to be shared with other researchers at this point, since this is a feasibility study with only 60 participants

    Learn more about this trial

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

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