Ultra-low Dose Oral Ketamine for Chronic Pain in the Primary Care Setting (Ketamine)
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|ClinicalTrials.gov Identifier: NCT02303847|
Recruitment Status : Unknown
Verified May 2015 by Lucinda Grande, University of Washington.
Recruitment status was: Active, not recruiting
First Posted : December 1, 2014
Last Update Posted : May 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Drug: Ketamine||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Ultra-low Dose Oral Ketamine for Treatment of Chronic Non-cancer Pain in the Primary Care Setting|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||June 2015|
Active Comparator: Active Drug
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
ultra-low dose oral ketamine twice daily in two different doses over a 2 week period.
Placebo Comparator: Placebo
Flavored syrup (without ketamine) by mouth twice daily for 2 weeks
- 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
- Reduction in opioid use (self-reported average opioid dose) [ Time Frame: 2 weeks ]Reduction after two weeks in self-reported average opioid dose, converted to morphine equivalents.
- Reduction in depression (PHQ-9 depression score) [ Time Frame: 2 weeks ]Reduction in depression, using the PHQ-9 depression score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303847
|United States, Washington|
|Pioneer Family Practice|
|Lacey, Washington, United States, 98503|
|Principal Investigator:||Lucinda Grande, MD||University of Washington Department of Family Medicine|