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Ketamine + Psychotherapy 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

PSYKED-NP Trial 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.Check my eligibility

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.See study design

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.

PSYKED-NP Trial 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.

PSYKED-NP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence rate

Frequency of adverse events

Recruitment rate

Secondary outcome measures

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

PSYKED-NP 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Akash GoelLead Sponsor

Unity Health TorontoLead Sponsor

540 Previous Clinical Trials

447,720 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants being recruited for this research investigation?

"Indeed, the information provided on clinicaltrials.gov indicates that this trial is currently seeking participants. The trial was initially posted on October 12th, 2023 and was last updated on January 22nd, 2024. The study aims to enroll a total of 60 patients at one designated site."

Answered by AI

Are new participants currently being recruited for this ongoing medical study?

"Indeed, the information available on clinicaltrials.gov indicates that this trial is actively seeking individuals to participate. The initial posting date for the study was October 12th, 2023, and it underwent its most recent update on January 22nd, 2024. The trial aims to enroll a total of 60 participants at a single location."

Answered by AI

What is the level of safety associated with the combined administration of ketamine and psychotherapy for individuals?

"This Phase 4 clinical trial, which assesses the safety of Ketamine + Psychotherapy, has been given a score of 3 by our team at Power. This is due to the treatment already being approved and available for use."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Akash Goel 2023. "Psychotherapy for Ketamine's Enhanced Durability in Chronic Neuropathic Pain: A Randomized Controlled Pilot Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05639322.

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