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

NCT02303847 | Unknown Phase 3

• 1 other identifier: 20141809
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Reduction in opioid use (self-reported average opioid dose)

  2 weeks

Other Outcomes (1)

• Reduction in depression (PHQ-9 depression score)

  2 weeks

Study Arms (2)

Active Drug

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

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

Flavored syrup (without ketamine) by mouth twice daily for 2 weeks

Interventions

Ketamine DRUG

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

Active Drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Pioneer Family Practice

Lacey, Washington, 98503, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Lucinda Grande, MD

  University of Washington Department of Family Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Care Physician

Study Record Dates

• First Submitted: November 25, 2014
• First Posted: December 1, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

US (1)