Psychotherapy for Ketamine's Enhanced Durability in Chronic Neuropathic Pain: A Randomized Controlled Pilot Trial
NCT ID: NCT05639322
Last Updated: 2024-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
30 participants
INTERVENTIONAL
2023-10-12
2026-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Ketamine only
Ketamine Hydrochloride
Ketamine-HCL IV 1mg/kg (up to 100 mg) over 2 hours, on weeks 2, 7, and 12.
Psychotherapy only
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
Ketamine + Psychotherapy
Ketamine + Cognitive Behavioral Therapy
Ketamine-HCL + CBT/MM according to the same directions specified in Arm 1 and Arm 2.
Interventions
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Ketamine Hydrochloride
Ketamine-HCL IV 1mg/kg (up to 100 mg) over 2 hours, on weeks 2, 7, and 12.
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
Ketamine + Cognitive Behavioral Therapy
Ketamine-HCL + CBT/MM according to the same directions specified in Arm 1 and Arm 2.
Eligibility Criteria
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Inclusion Criteria
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
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 \[e.g. presence of dyspnea, peripheral edema, elevated jugular venous pressure, hepatomegaly, pulmonary rales, pleural effusions\])
18 Years
ALL
No
Sponsors
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Unity Health Toronto
OTHER
Responsible Party
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Locations
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St. Michael's Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Goel A, Kapoor B, Chan H, Ladha K, Katz J, Clarke H, Pazmino-Canizares J, Thomas Z, Philip K, Mattina G, Ritvo P. Psychotherapy for Ketamine's Enhanced Durability in Chronic Neuropathic Pain: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 17;13:e54406. doi: 10.2196/54406.
Other Identifiers
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P-003
Identifier Type: -
Identifier Source: org_study_id
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