Clinical trial · Interventional
Ultra-low Dose Oral Ketamine for Chronic Pain in the Primary Care Setting
Ultra-low Dose Oral Ketamine for Treatment of Chronic Non-cancer Pain in the Primary Care Setting
NCT02303847CI-TRIAL-00018043KetamineunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This project is a pilot study to evaluate the analgesic and opioid-sparing effects of ketamine in an ultra-low dose oral formulation as a novel intervention for treatment of chronic non-cancer pain in opioid-tolerant patients in the primary care outpatient setting.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ketamine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Active Drug
- description
- ketamine 16 mg in flavored syrup by mouth twice daily for 1 week, then ketaming 32 mg in flavored syrup by mouth twice daily for 1 week
- interventionNames
- Drug: Ketamine
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Flavored syrup (without ketamine) by mouth twice daily for 2 weeks
Primary outcomes (2)
- measure
- Pain improvement (Brief Pain Inventory (BPI) Mean Pain Severity Scale)
- timeFrame
- 2 weeks
- description
- Improvement after 2 weeks in pain as measured by the Brief Pain Inventory (BPI) Mean Pain Severity Scale
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * Routine use of an opioid medication for non-cancer pain for more than six months * A current average daily dose of greater than or equal to 20 mg morphine or equivalent * Current prescription of an as-needed opioid suitable for downward titration during the study period * Ability to provide informed consent Ability to adhere to the study protocol Exclusion Criteria: * Uncontrolled hypertension, cardiac arrhythmia or other known cardiac disease, * elevated intracranial pressure, * severe glaucoma, * schizophrenia, * diagnosed substance use disorder, or * other unstable medical or psychiatric illness or pregnancy.
References
Publications (0)
Data not yet available
No reference posted for this study.