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

University of Washington

Status and phase: Unknown; Phase 3

Conditions: Chronic Pain

Treatments: Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT02303847

20141809

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 2 patient groups, including a placebo group

Active Drug

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine

Placebo

Placebo Comparator group

Description:

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