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

Chronic Pain Clinical Trial

— Ketamine  

Official title:

Ultra-low Dose Oral Ketamine for Treatment of Chronic Non-cancer Pain in the Primary Care Setting

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02303847
• Other study ID #: 20141809
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 25, 2014
• Last updated: May 24, 2015
• Start date: November 2014
• Est. completion date: June 2015

Study information

• Verified date: May 2015
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• Ketamine
ultra-low dose oral ketamine twice daily in two different doses over a 2 week period.

Locations

Country	Name	City	State
United States	Pioneer Family Practice	Lacey	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reduction in depression (PHQ-9 depression score)	Reduction in depression, using the PHQ-9 depression score	2 weeks	No
Primary	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	No
Primary	Function improvement (BPI Mean Interference Scale)	Improvement after 2 weeks in functional status as measured by the BPI Mean Interference Scale	2 weeks	No
Secondary	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	Yes