Propofol-Enhanced Assessment of Ketamine for Chronic Pain and Depression (PEAK)

Stanford University

Status and phase: Active, not recruiting; Phase 4

Conditions: Chronic Pain; Depression

Treatments: Drug: Normal saline; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT06317636

73487

Details and patient eligibility

About

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

Full 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.

Enrollment for the n=6 pilot phase is complete as of 6/19/2025.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

40 participants in 2 patient groups, including a placebo group

Ketamine

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine

Saline

Placebo Comparator group

Description:

A one-time intravenous infusion of normal saline

Treatment:

Drug: Normal saline