Propofol-Enhanced Assessment of Ketamine for Chronic Pain and Depression

NCT06317636 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 73487
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Pain; Depression

Keywords

Chronic Pain; Depression; Ketamine; Propofol; Sedation; Psychotropic Drugs; Hypnotics and Sedatives; Dissociative Anesthetics

Outcome Measures

Primary Outcomes (1)

• Pain intensity in the past 24 hours

  A numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain) over the past 24 hours will be used to assess pain intensity.

  screening; 1, 7, 14, 21 and 28 days after treatment

Secondary Outcomes (1)

• Depression Severity and Blinding

  screening; day of infusion pre-treatment; 7, 14, 21 and 28 days after treatment

Other Outcomes (19)

• Number and severity of adverse events related to sedation

  during treatment; day of infusion post-treatment; 1, 7, 14, 21 and 28 days after treatment

• Side effects related to ketamine

  day of infusion post-treatment; 1, 7, 14, 21 and 28 days after treatment

• Proportion of participants who accurately recall intra-sedation events

  day of infusion post-treatment

Study Arms (2)

Ketamine

ACTIVE COMPARATOR

A one-time intravenous infusion of ketamine (0.5 mg/kg)

Drug: Ketamine

Saline

PLACEBO COMPARATOR

A one-time intravenous infusion of normal saline

Drug: Normal saline

Interventions

Ketamine DRUG

0.5 mg/kg ketamine infused intravenously over 40 minutes

Also known as: Ketalar

Ketamine

Normal saline DRUG

0.9% normal saline infused intravenously over 40 minutes

Also known as: 0.9% NaCl

Saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Chronic Pain; Depression

Interventions

Ketamine; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Theresa Lii, MD, MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 19, 2024
• Study Start: January 28, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Available upon request after publication of the trial's primary findings for up to 5 years.
• Access Criteria: Researchers must submit a brief proposal and statistical analysis plan for review and approval by the investigators and execute a data sharing agreement.

Locations

US (1)