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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine only | Active Comparator |
| |
| Psychotherapy only | Active Comparator |
| |
| Ketamine + Psychotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine Hydrochloride | Drug | Ketamine-HCL IV 1mg/kg (up to 100 mg) over 2 hours, on weeks 2, 7, and 12. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Recruitment rate and withdrawal rate (Acceptability and feasibility study) | 2 years |
| Adherence rate | Feasibility | 2 years |
| Frequency of adverse events | Safety and tolerability | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS) Pain Intensity, 1 a. | PROMIS-PI - 1 a. pain intensity scale- 0 to 10 (The higher the number the higher the pain intensity) | 20 weeks |
| Patient-Reported Outcomes Measurement Information System Pain Interference, PROMIS 6 a. Pain Interference, |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38630524 | Derived | 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. |
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No individual participant data has been planned to be shared with other researchers at this point, since this is a feasibility study with only 30 participants
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| Cognitive Behavioral Therapy | Behavioral | 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 | Other | Ketamine-HCL + CBT/MM according to the same directions specified in Arm 1 and Arm 2. |
|
PROMIS-PI -Short form 6 a. - pain interference scale- 6 items, 5 likert scale The higher the score the higher the interference from pain) |
| 20 weeks |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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