Clinical trial NCT06317636: Propofol-Enhanced Assessment of Ketamine for Chronic Pain and Depression
Official title: Randomized, Double-blind, Placebo-controlled, Single-center, Noninferiority Trial of Ketamine Given During Sedation to Patients With Chronic Pain and Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Chronic Pain
Depression
Keywords: Chronic Pain
Depression
Ketamine
Propofol
Sedation
Psychotropic Drugs
Hypnotics and Sedatives
Dissociative Anesthetics
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare ketamine to a placebo when given as a single infusion during IV sedation in adults with chronic pain and depression. We do not know whether ketamine will be more effective than placebo under these circumstances.

This study aims to:

* Evaluate whether placebo is non-inferior to ketamine in treating chronic pain and depression, when delivered under propofol sedation
* Confirm that propofol sedation is a safe way to keep participants blinded to treatment
* Assess patients' comfort with the sedation process to improve future studies
* Explore whether patient expectations affects their pain and depression

Participants will:

* Need to qualify for the study based on stringent medical criteria
* Undergo sedation with propofol
* Randomly receive either a ketamine or a placebo (saline) infusion during sedation
* Complete several study assessments over 5-7 weeks

Detailed description: Ketamine is a dissociative anesthetic that has been in clinical use for more than 50 years. In addition to its well-known anesthetic and pain-relieving properties, ketamine has been found to have fast-acting antidepressant effects in patients with depression. However, the mechanisms underlying ketamine's ability to treat chronic pain and depression are poorly understood. A most basic question regarding ketamine's therapeutic mechanism is still unresolved: do patients need to consciously experience and recall ketamine's acute dissociative effects to receive lasting analgesic and antidepressant benefits? In this clinical trial, participants will receive either ketamine or a placebo when they are under sedation with propofol. A n=6 pilot feasibility phase will precede the fully-powered n=34 randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 70 years old
* Comfortable speaking and writing in English
* Chronic pain present daily for at least 3 months
* Currently experiencing depression
* Able to comply with the study protocol and communicate with study personnel about adverse events and other clinically important information

Exclusion Criteria:

* Pregnant or breastfeeding
* One or more health conditions that makes study unsafe or unfeasible, determined by study physicians
* Regular use of medications that may have problematic interactions with the study drugs
* Participating in another clinical trial which may conflict with this one

Primary outcomes:
measure: Pain intensity in the past 24 hours
timeFrame: screening; 1, 7, 14, 21 and 28 days after treatment
Secondary outcomes:
measure: Depression severity
timeFrame: screening; day of infusion pre-treatment; 7, 14, 21 and 28 days after treatment
Other outcomes:
measure: Number and severity of adverse events related to sedation
timeFrame: during treatment; day of infusion post-treatment; 1, 7, 14, 21 and 28 days after treatment
measure: Side effects related to ketamine
timeFrame: day of infusion post-treatment; 1, 7, 14, 21 and 28 days after treatment
measure: Proportion of participants who accurately recall intra-sedation events
timeFrame: day of infusion post-treatment
measure: Treatment guess
timeFrame: day of infusion post-treatment, 1, 7, 14, 21, and 28 days after treatment
measure: Participant expectations
timeFrame: screening; day of infusion post-treatment; 1, 7, 14, 21 and 28 days after treatment
measure: Pressure pain threshold
timeFrame: day of infusion pre-treatment; day of infusion post-treatment
measure: Mechanical temporal summation
timeFrame: day of infusion pre-treatment; day of infusion post-treatment
measure: Conditioned pain modulation
timeFrame: day of infusion pre-treatment; day of infusion post-treatment
measure: Number of painful body regions
timeFrame: screening; day of infusion pre-treatment; day of infusion post-treatment; 1, 7, 14, 21 and 28 days after treatment
measure: Pain interference
timeFrame: screening; day of infusion pre-treatment; 7, 14, 21 and 28 days after treatment
measure: Change in pain medication utilization
timeFrame: 1, 7, 14, 21 and 28 days after treatment
measure: Physical function
timeFrame: screening; day of infusion pre-treatment; 7, 14, 21 and 28 days after treatment
measure: Sleep disturbance
timeFrame: screening; day of infusion pre-treatment; 7, 14, 21 and 28 days after treatment
measure: Anxiety symptom severity
timeFrame: screening; day of infusion pre-treatment; 14 and 28 days after treatment]
measure: Peace of mind
timeFrame: screening; day of infusion pre-treatment; 7 and 28 days after treatment
measure: Emotion regulation
timeFrame: screening; day of infusion pre-treatment; 7 and 28 days after treatment
measure: Anhedonia
timeFrame: screening; day of infusion pre-treatment; 14 and 28 days after treatment
measure: Enrollment rate
timeFrame: from date of opening enrollment to the date of consent from the last participant, assessed up to 60 months
measure: Consent fraction
timeFrame: from date of opening enrollment to the date of consent from the last participant, assessed up to 60 months
measure: Participant Experience Survey
timeFrame: through study completion, an average of 4 weeks
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Theresa Lii, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: