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Ketamine + Cognitive Behavioral Therapy for Neuropathic Pain (PSYKED-NP Trial)

Phase 4
Recruiting
Research Sponsored by Akash Goel
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Capacity to provide informed consent
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

This trial is studying new treatments for chronic nerve pain. The main goal is to conduct a small study with 60 participants who have this type of pain. The participants will be randomly assigned to receive either

Who is the study for?
This trial is for adults over 18 with moderate-to-severe chronic neuropathic pain, as confirmed by a specialist and specific pain scores. Participants must be able to consent and if of childbearing potential, use effective contraception or practice abstinence.
What is being tested?
The study tests three approaches: Ketamine Hydrochloride alone, Cognitive Behavioral Therapy (CBT) alone, and a combination of both. The goal is to see which method best alleviates chronic neuropathic pain in this pilot study with 60 participants.
What are the potential side effects?
Ketamine may cause side effects like dizziness, nausea, increased blood pressure, mood changes, or hallucinations. CBT generally doesn't have physical side effects but can sometimes lead to emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I understand and can agree to the study's procedures and risks.
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I have chronic nerve pain rated above 3 out of 10 in the last week.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence rate
Frequency of adverse events
Recruitment rate
Secondary study objectives
Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS) Pain Intensity, 1 a.
Patient-Reported Outcomes Measurement Information System Pain Interference, PROMIS 6 a. Pain Interference

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Ketamine + PsychotherapyExperimental Treatment1 Intervention
Group II: Psychotherapy onlyActive Control1 Intervention
Group III: Ketamine onlyActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Akash GoelLead Sponsor
Unity Health TorontoLead Sponsor
562 Previous Clinical Trials
453,858 Total Patients Enrolled
~11 spots leftby Oct 2025
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