Ultra-low Dose Oral Ketamine for Chronic Pain in the Primary Care Setting (Ketamine)

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Pain
• Intervention / Treatment: Drug: Ketamine

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: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Washington
    • Lacey, Washington, United States, 98503
      • Pioneer Family Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 weeks
Function improvement (BPI Mean Interference Scale)	Improvement after 2 weeks in functional status as measured by the BPI Mean Interference Scale	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in opioid use (self-reported average opioid dose)	Reduction after two weeks in self-reported average opioid dose, converted to morphine equivalents.	2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in depression (PHQ-9 depression score)	Reduction in depression, using the PHQ-9 depression score	2 weeks

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Lucinda Grande, MD, University of Washington Department of Family Medicine

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: November 25, 2014
• First Submitted That Met QC Criteria: November 28, 2014
• First Posted (Estimate): December 1, 2014

Study Record Updates

• Last Update Posted (Estimate): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 24, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 20141809