CompletedPhase 4

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

Canada30 participantsStarted 2023-10-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Recruitment rate

Timeframe: 2 years

Adherence rate

Timeframe: 2 years

Frequency of adverse events

Timeframe: 2 years

Trial details

NCT IDNCT05639322

SponsorUnity Health Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-24

View on ClinicalTrials.gov More Neuropathic Pain trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)