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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

Tracking Information
First Submitted Date  ICMJE November 25, 2014
First Posted Date  ICMJE December 1, 2014
Last Update Posted Date May 27, 2015
Study Start Date  ICMJE November 2014
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2014)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 28, 2014)
Reduction in depression (PHQ-9 depression score) [ Time Frame: 2 weeks ]
Reduction in depression, using the PHQ-9 depression score
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Ultra-low Dose Oral Ketamine for Chronic Pain in the Primary Care Setting
Official Title  ICMJE Ultra-low Dose Oral Ketamine for Treatment of Chronic Non-cancer Pain in the Primary Care Setting
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE Drug: Ketamine
ultra-low dose oral ketamine twice daily in two different doses over a 2 week period.
Study Arms  ICMJE
  • 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
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo
    Flavored syrup (without ketamine) by mouth twice daily for 2 weeks
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 28, 2014)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2015
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02303847
Other Study ID Numbers  ICMJE 20141809
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lucinda Grande, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lucinda Grande, MD University of Washington Department of Family Medicine
PRS Account University of Washington
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP