Neuropathic Pain
Conditions
Keywords
Feasibility trial, Ketamine, Cognitive behavioural therapy
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 30 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.
Interventions
DRUGKetamine Hydrochloride
Ketamine-HCL IV 1mg/kg (up to 100 mg) over 2 hours, on weeks 2, 7, and 12.
BEHAVIORALCognitive 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
OTHERKetamine + Cognitive Behavioral Therapy
Ketamine-HCL + CBT/MM according to the same directions specified in Arm 1 and Arm 2.
Sponsors
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 \[e.g. presence of dyspnea, peripheral edema, elevated jugular venous pressure, hepatomegaly, pulmonary rales, pleural effusions\])
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 2 years | Recruitment rate and withdrawal rate (Acceptability and feasibility study) |
| Adherence rate | 2 years | Feasibility |
| Frequency of adverse events | 2 years | Safety and tolerability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS) Pain Intensity, 1 a. | 20 weeks | PROMIS-PI - 1 a. pain intensity scale- 0 to 10 (The higher the number the higher the pain intensity) |
| Patient-Reported Outcomes Measurement Information System Pain Interference, PROMIS 6 a. Pain Interference, | 20 weeks | PROMIS-PI -Short form 6 a. - pain interference scale- 6 items, 5 likert scale The higher the score the higher the interference from pain) |
Countries
Canada
Outcome results
None listed