ACTIVE_NOT_RECRUITING

Propofol-Enhanced Assessment of Ketamine for Chronic Pain and Depression

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Randomized, Double-blind, Placebo-controlled, Single-center, Noninferiority Trial of Ketamine Given During Sedation to Patients With Chronic Pain and Depression

Quick Facts

Study Start:2025-01-28
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06317636

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 to 70 years old
  2. * Comfortable speaking and writing in English
  3. * Chronic pain present daily for at least 3 months
  4. * Currently experiencing depression
  5. * Able to comply with the study protocol and communicate with study personnel about adverse events and other clinically important information
  1. * Pregnant or breastfeeding
  2. * One or more health conditions that makes study unsafe or unfeasible, determined by study physicians
  3. * Regular use of medications that may have problematic interactions with the study drugs
  4. * Participating in another clinical trial which may conflict with this one

Contacts and Locations

Principal Investigator

Theresa Lii, MD, MS
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

Stanford University
Stanford, California, 94305
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Theresa Lii, MD, MS, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-28
Study Completion Date2026-12

Study Record Updates

Study Start Date2025-01-28
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Chronic Pain
  • Depression