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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
Sponsor:
Information provided by (Responsible Party):
Lucinda Grande, University of Washington

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: Ketamine Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
Drug Information available for: Ketamine

Arm Intervention/treatment
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
Drug: Ketamine
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



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Reduction in depression (PHQ-9 depression score) [ Time Frame: 2 weeks ]
    Reduction in depression, using the PHQ-9 depression score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Washington
Pioneer Family Practice
Lacey, Washington, United States, 98503
Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: Lucinda Grande, MD University of Washington Department of Family Medicine

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Responsible Party: Lucinda Grande, Primary Care Physician, University of Washington
ClinicalTrials.gov Identifier: NCT02303847     History of Changes
Other Study ID Numbers: 20141809
First Posted: December 1, 2014    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Ketamine
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action