Clinical trial NCT05639322: Psychotherapy for Ketamine's Enhanced Durability in Chronic Neuropathic Pain: A Randomized Controlled Pilot Trial
Official title: Psychotherapy for Ketamine's Enhanced Durability in Chronic Neuropathic Pain: A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Neuropathic Pain
Keywords: Feasibility trial
Ketamine
Cognitive behavioural therapy
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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.


Eligibility criteria: 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 \[e.g. presence of dyspnea, peripheral edema, elevated jugular venous pressure, hepatomegaly, pulmonary rales, pleural effusions\])

Primary outcomes:
measure: Recruitment rate
timeFrame: 2 years
measure: Adherence rate
timeFrame: 2 years
measure: Frequency of adverse events
timeFrame: 2 years
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS) Pain Intensity, 1 a.
timeFrame: 20 weeks
measure: Patient-Reported Outcomes Measurement Information System Pain Interference, PROMIS 6 a. Pain Interference,
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
References: