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

Study Overview
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Brief Summary
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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.

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

Conditions
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Neuropathic Pain

Intervention / Treatment
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* Drug: Ketamine Hydrochloride
* Behavioral: Cognitive Behavioral Therapy
* Other: Ketamine + Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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])

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketamine only<br> | Drug: Ketamine Hydrochloride<br>* Ketamine-HCL IV 1mg/kg (up to 100 mg) over 2 hours, on weeks 2, 7, and 12.<br>|
| Active Comparator: Psychotherapy only<br> | Behavioral: Cognitive Behavioral Therapy<br>* 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<br>|
| Experimental: Ketamine + Psychotherapy<br> | Other: Ketamine + Cognitive Behavioral Therapy<br>* Ketamine-HCL + CBT/MM according to the same directions specified in Arm 1 and Arm 2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 20 weeks | 
| 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) | 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Feasibility trial, Keteamine, Cognitive behavioural therapy