Chronic PainPhase 3KetamineNCT02303847
Ultra-low Dose Oral Ketamine for Chronic Pain in the Primary Care Setting
A Phase 3 study testing Ketamine in people with Chronic Pain, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Ketamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jun 2015
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultra-low Dose Oral Ketamine for Treatment of Chronic Non-cancer Pain in the Primary Care Setting
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.
Read the detailed description
Chronic pain is a major national public health issue, affecting about 100 million adults in the United States. Opioid pain medications are commonly used for treatment of chronic pain, but their use is fraught with consequences including an increasing prevalence of misuse, abuse, and overdose death, and side effects which lead to a reduced quality of life. An effective and safe medication that would improve control of chronic pain while reducing reliance on opioid medications would be valuable for patients, medical providers and society at large.
Ketamine, commonly used as an intravenous anesthetic agent, has been shown to have analgesic and opioid-sparing effects in the peri-operative period and in the palliative care setting. Based on promising preliminary data from an open-label treatment trial, 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 the primary care outpatient setting.
The design of the proposed study is a randomized controlled two week parallel-group trial, with 32 patients receiving either the active treatment or placebo twice daily.
- Conditions
- Chronic Pain
- Being tested
- Ketamine
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
ultra-low dose oral ketamine twice daily in two different doses over a 2 week period.
| Study group | Role | What they receive |
|---|---|---|
| Active Drug | Active comparator | 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 Receives: Drug: Ketamine |
| Placebo | Placebo comparator | Flavored syrup (without ketamine) by mouth twice daily for 2 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain improvement (Brief Pain Inventory (BPI) Mean Pain Severity Scale)
Improvement after 2 weeks in pain as measured by the Brief Pain Inventory (BPI) Mean Pain Severity Scale
Measured: 2 weeks
Function improvement (BPI Mean Interference Scale)
Improvement after 2 weeks in functional status as measured by the BPI Mean Interference Scale
Measured: 2 weeks
Secondary outcomes (1)
Reduction in opioid use (self-reported average opioid dose)
Reduction after two weeks in self-reported average opioid dose, converted to morphine equivalents.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucinda Grande, University of Washington
- Investigators
- Lucinda Grande, MD, Principal investigator, University of Washington Department of Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303847
- Sponsor's protocol ID
- 20141809
- Acronym
- Ketamine
- Status last verified
- May 2015
- First submitted
- 25 Nov 2014
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-low Dose Oral Ketamine for Treatment of Chronic Non-cancer Pain in the Primary Care Setting
- ClinicalTrials.gov ID
- NCT02303847
- Acronym / sponsor ID
- Ketamine / 20141809
- Conditions
- Chronic Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 1 Dec 2014 (estimated)
- 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.
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.
Detailed description
Chronic pain is a major national public health issue, affecting about 100 million adults in the United States. Opioid pain medications are commonly used for treatment of chronic pain, but their use is fraught with consequences including an increasing prevalence of misuse, abuse, and overdose death, and side effects which lead to a reduced quality of life. An effective and safe medication that would improve control of chronic pain while reducing reliance on opioid medications would be valuable for patients, medical providers and society at large.
Ketamine, commonly used as an intravenous anesthetic agent, has been shown to have analgesic and opioid-sparing effects in the peri-operative period and in the palliative care setting. Based on promising preliminary data from an open-label treatment trial, 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 the primary care outpatient setting.
The design of the proposed study is a randomized controlled two week parallel-group trial, with 32 patients receiving either the active treatment or placebo twice daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Drug | Active comparator | Drug: Ketamineketamine 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 |
| Placebo | Placebo comparator | –Flavored syrup (without ketamine) by mouth twice daily for 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Uncontrolled hypertension, cardiac arrhythmia or other known cardiac disease,
- elevated intracranial pressure,
- severe glaucoma,
- schizophrenia,
- diagnosed substance use disorder, or
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 |
|---|---|---|
| Ketamineultra-low dose oral ketamine twice daily in two different doses over a 2 week period. | Drug | Active Drug |
Primary outcome
Pain improvement (Brief Pain Inventory (BPI) Mean Pain Severity Scale)
Time frame: 2 weeks
Improvement after 2 weeks in pain as measured by the Brief Pain Inventory (BPI) Mean Pain Severity Scale
Function improvement (BPI Mean Interference Scale)
Time frame: 2 weeks
Improvement after 2 weeks in functional status as measured by the BPI Mean Interference Scale
1 secondary outcome
Reduction in opioid use (self-reported average opioid dose)
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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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.
Lucinda Grande, MD principal investigator
University of Washington Department of Family Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketamine in people with Chronic Pain, run by University of Washington at 1 site in United States.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 May 2015. 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 United States. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Pain improvement (Brief Pain Inventory (BPI) Mean Pain Severity Scale) (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2015.