Psychotherapy for Ketamine's Enhanced Durability in Chronic Neuropathic Pain: A Randomized Controlled Pilot Trial
This Phase IV, randomised controlled trial (n=30) will evaluate the effectiveness of ketamine and psychotherapy in managing chronic neuropathic pain. Participants aged 18 and older with moderate-to-severe neuropathic pain will be assigned to one of three groups: ketamine hydrochloride (1 mg/kg IV, up to 100 mg) administered on weeks 2, 7, and 12, cognitive behavioural therapy (CBT) combined with mindfulness-based meditation delivered remotely for 16 hours over weeks 1 to 16 with in-person sessions on specified weeks, or a combination of both interventions. The trial aims to assess the feasibility of these treatments, focusing on recruitment and adherence rates, as well as the frequency of adverse events over a two-year period. Participants will be monitored for their response to the interventions, with the primary outcomes including the rate of recruitment, adherence to the treatment protocol, and any adverse events experienced during the study. The trial is sponsored by Unity Health Toronto and is set to conclude in July 2025.
Detailed Description
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.
Study Arms & Interventions
Ketamine only
active comparatorInterventions
- Ketamine1 - 100 mgvia IV• on weeks 2, 7, and 12• 3 doses total
Psychotherapy only
active comparatorInterventions
- Placebo• remotely for 16 hours between weeks 1 to 16 inclusive + in-person sessions on weeks 2, 7 and 12
Unmatched intervention: Cognitive Behavioral Therapy
Ketamine + Psychotherapy
experimentalInterventions
- Ketamine1 - 100 mgvia IV• on weeks 2, 7, and 12 + remotely for 16 hours between weeks 1 to 16 inclusive + in-person sessions on weeks 2, 7 and 12• 3 doses total
Participants
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 \[e.g. presence of dyspnea, peripheral edema, elevated jugular venous pressure, hepatomegaly, pulmonary rales, pleural effusions\])
Study Details
- StatusCompleted
- PhasePhase IV
- Typeinterventional
- DesignRandomizeddouble Blind
- Target Enrollment30 participants
- TimelineStart: 2023-10-12End: 2025-07-24
- Compounds
- Topic
Study Team
Sponsors & Collaborators
- Unity Health TorontoPrimary Sponsor