Overview

This trial is active, not recruiting.

Condition chronic pain
Treatment ketamine
Phase phase 3
Sponsor University of Washington
Start date November 2014
End date June 2015
Trial size 32 participants
Trial identifier NCT02303847, 20141809

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(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
ketamine
ultra-low dose oral ketamine twice daily in two different doses over a 2 week period.
(Placebo Comparator)
Flavored syrup (without ketamine) by mouth twice daily for 2 weeks

Primary Outcomes

Measure
Pain improvement (Brief Pain Inventory (BPI) Mean Pain Severity Scale)
time frame: 2 weeks
Function improvement (BPI Mean Interference Scale)
time frame: 2 weeks

Secondary Outcomes

Measure
Reduction in opioid use (self-reported average opioid dose)
time frame: 2 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Ultra-low Dose Oral Ketamine for Treatment of Chronic Non-cancer Pain in the Primary Care Setting
Principal investigator Lucinda Grande, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Washington.