Neuropathic PainPhase 4PSYKED-NPNCT05639322
Psychotherapy for Ketamine's Enhanced Durability in Chronic Neuropathic Pain: A Randomized Controlled Pilot Trial
A Phase 4 study testing Ketamine Hydrochloride, Cognitive Behavioral Therapy and Ketamine + Cognitive Behavioral Therapy in people with Neuropathic Pain, run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Ketamine Hydrochloride, Cognitive Behavioral Therapy and Ketamine + Cognitive Behavioral Therapy
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 12 Oct 2023to 24 Jul 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
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- Pregnancy or ongoing breastfeeding in female participants
- Concomitant active substance use in the 6 months preceding enrolment (amphetamines, alcohol, and ketamine)
- 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])
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Neuropathic Pain
- Being tested
- Ketamine Hydrochloride, Cognitive Behavioral Therapy, Ketamine + Cognitive Behavioral Therapy
- Keywords
- Feasibility trial, Ketamine, Cognitive behavioural therapy
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HydrochlorideDrug
Ketamine-HCL IV 1mg/kg (up to 100 mg) over 2 hours, on weeks 2, 7, and 12.
Cognitive Behavioral TherapyBehavioural
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 TherapyOther
Ketamine-HCL + CBT/MM according to the same directions specified in Arm 1 and Arm 2.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine only | Active comparator | Not described Receives: Drug: Ketamine Hydrochloride |
| Psychotherapy only | Active comparator | Not described Receives: Behavioral: Cognitive Behavioral Therapy |
| Ketamine + Psychotherapy | Experimental | Not described Receives: Other: Ketamine + Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Recruitment rate and withdrawal rate (Acceptability and feasibility study)
Measured: 2 years
Adherence rate
Feasibility
Measured: 2 years
Frequency of adverse events
Safety and tolerability
Measured: 2 years
Secondary outcomes (2)
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)
Measured: 20 weeks
Patient-Reported Outcomes Measurement Information System Pain Interference, PROMIS 6 a. Pain Interference,
PROMIS-PI -Short form 6 a. - pain interference scale- 6 items, 5 likert scale The higher the score the higher the interference from pain)
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start12 Oct 2023
- Primary completion24 Jul 2025
- Study completion24 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639322
- Sponsor's protocol ID
- P-003
- Acronym
- PSYKED-NP
- Status last verified
- Oct 2025
- First submitted
- 28 Nov 2022
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
Goel A, Diep C, Zahin A, Rosenblat JD, Pereira SM, Teja B, Rao K, Pritlove C, Hodwitz K, Clarke H, Katz J, Wijeysundera DN, Pazmino-Canizares J, Mattina G, Nayar R, Thomas Z, Dang K, Ladha KS, Ritvo P; KARE Collaborators. Ketamine assisted psychotherapy to reduce chronic neuropathic pain: A mixed-methods randomized pilot trial. Med. 2026 Aug 13:101259. doi: 10.1016/j.medj.2026.101259. Online ahead of print.
PubMed 42594864Goel 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.
PubMed 38630524
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychotherapy for Ketamine's Enhanced Durability in Chronic Neuropathic Pain: A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT05639322
- Acronym / sponsor ID
- PSYKED-NP / P-003
- Conditions
- Neuropathic Pain
- Keywords
- Feasibility trial, Ketamine, Cognitive behavioural therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 24 Jul 2025 (actual)
- Study completion
- 24 Jul 2025 (actual)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketamine only | Active comparator | Drug: Ketamine Hydrochloride |
| Psychotherapy only | Active comparator | Behavioral: Cognitive Behavioral Therapy |
| Ketamine + Psychotherapy | Experimental | Other: Ketamine + Cognitive Behavioral Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine HydrochlorideKetamine-HCL IV 1mg/kg (up to 100 mg) over 2 hours, on weeks 2, 7, and 12. | Drug | Ketamine only |
| Cognitive Behavioral TherapyCognitive 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 | Behavioural | Psychotherapy only |
| Ketamine + Cognitive Behavioral TherapyKetamine-HCL + CBT/MM according to the same directions specified in Arm 1 and Arm 2. | Other | Ketamine + Psychotherapy |
Primary outcome
Recruitment rate
Time frame: 2 years
Recruitment rate and withdrawal rate (Acceptability and feasibility study)
Adherence rate
Time frame: 2 years
Feasibility
Frequency of adverse events
Time frame: 2 years
Safety and tolerability
2 secondary outcomes
Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS) Pain Intensity, 1 a.
Time frame: 20 weeks
Patient-Reported Outcomes Measurement Information System Pain Interference, PROMIS 6 a. Pain Interference,
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Derived from this study: PubMed 42594864Goel A, Diep C, Zahin A, Rosenblat JD, Pereira SM, Teja B, Rao K, Pritlove C, Hodwitz K, Clarke H, Katz J, Wijeysundera DN, Pazmino-Canizares J, Mattina G, Nayar R, Thomas Z, Dang K, Ladha KS, Ritvo P; KARE Collaborators. Ketamine assisted psychotherapy to reduce chronic neuropathic pain: A mixed-methods randomized pilot trial. Med. 2026 Aug 13:101259. doi: 10.1016/j.medj.2026.101259. Online ahead of print.
- Derived from this study: PubMed 38630524Goel 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine Hydrochloride, Cognitive Behavioral Therapy and Ketamine + Cognitive Behavioral Therapy in people with Neuropathic Pain, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05639322, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.