NCT05639322

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 (Hydrochloride) HCL; (2) psychotherapy (using Cognitive Behavioral Therapy); or (3) a combination of Ketamine HL and psychotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 6, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

October 12, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2025

Completed
Last Updated

February 5, 2026

Status Verified

October 1, 2025

Enrollment Period

1.8 years

First QC Date

November 28, 2022

Last Update Submit

February 2, 2026

Conditions

Neuropathic Pain

Keywords

Feasibility trialKetamineCognitive behavioural therapy

Outcome Measures

Primary Outcomes (3)

  • Recruitment rate

    Recruitment rate and withdrawal rate (Acceptability and feasibility study)

    2 years

  • Adherence rate

    Feasibility

    2 years

  • Frequency of adverse events

    Safety and tolerability

    2 years

Secondary Outcomes (2)

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

    20 weeks

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

    20 weeks

Study Arms (3)

Ketamine only

ACTIVE COMPARATOR
Drug: Ketamine Hydrochloride

Psychotherapy only

ACTIVE COMPARATOR
Behavioral: Cognitive Behavioral Therapy

Ketamine + Psychotherapy

EXPERIMENTAL
Other: Ketamine + Cognitive Behavioral Therapy

Interventions

Ketamine HydrochlorideDRUG

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

Ketamine only
Cognitive Behavioral TherapyBEHAVIORAL

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

Psychotherapy only
Ketamine + Cognitive Behavioral TherapyOTHER

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

Ketamine + Psychotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥18 years of age
  • 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

You may not qualify if:

  • 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 \[e.g. presence of dyspnea, peripheral edema, elevated jugular venous pressure, hepatomegaly, pulmonary rales, pleural effusions\])

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (1)

  • Goel A, Kapoor B, Chan H, Ladha K, Katz J, Clarke H, Pazmino-Canizares J, Thomas Z, Philip K, Mattina G, Ritvo P. Psychotherapy for Ketamine's Enhanced Durability in Chronic Neuropathic Pain: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 17;13:e54406. doi: 10.2196/54406.

    PMID: 38630524DERIVED

MeSH Terms

Conditions

Neuralgia

Interventions

KetamineCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2022

First Posted

December 6, 2022

Study Start

October 12, 2023

Primary Completion

July 24, 2025

Study Completion

July 24, 2025

Last Updated

February 5, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

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

Locations

CA(1)