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

Neuropathic Pain Clinical Trial

— PSYKED-NP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05639322
• Other study ID #: P-003
• Status: Recruiting
• Phase: Phase 4
• Start date: October 12, 2023
• Est. completion date: December 15, 2026

Study information

• Verified date: June 2024
• Source: Unity Health Toronto
• Contact: Akash Goel, MD
• Phone: 416-864-5825
• Email: Akash.Goel[@]unityhealth.to
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 15, 2026
• Est. primary completion date: October 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. =18 years of age

2. 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

3. 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

4. Capacity to provide informed consent

Exclusion Criteria:

1. Patients less than 18 years of age

2. Current or lifetime history of schizophrenia, psychotic disorder, bipolar disorder, or borderline personality disorder

3. Known history of hypersensitivity or allergy to Ketamine-HCL

4. Current history of dissociative disorders

5. Current concomitant use of theophylline or aminophylline

6. Current elevated intracranial pressure

7. Pregnancy or ongoing breastfeeding in female participants

8. Concomitant active substance use in the 6 months preceding enrolment (amphetamines, alcohol, and ketamine)

9. 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])

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

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

Behavioral:
• Cognitive Behavioral Therapy
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

Other:
• Ketamine + Cognitive Behavioral Therapy
Ketamine-HCL + CBT/MM according to the same directions specified in Arm 1 and Arm 2.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Recruitment rate and withdrawal rate (Acceptability and feasibility study)	2 years
Primary	Adherence rate	Feasibility	2 years
Primary	Frequency of adverse events	Safety and tolerability	2 years
Secondary	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
Secondary	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