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

NCT ID: NCT02303847

Last Updated: 2015-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-06-30

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Ketamine

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

Ketamine

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Lucinda Grande

Primary Care Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucinda Grande, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington Department of Family Medicine

Locations

Pioneer Family Practice

Lacey, Washington, United States

Countries

United States

Other Identifiers

20141809

Identifier Type: -

Identifier Source: org_study_id