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NMDA Receptor Antagonist

Ketamine for Opioid Addiction

Phase 2
Waitlist Available
Led By Jacques E Chelly, MD
Research Sponsored by Jacques E. Chelly
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening visit
Awards & highlights

Study Summary

This trial will test whether ketamine can help chronic back pain patients by reducing their postoperative pain and opioid consumption.

Eligible Conditions
  • Opioid Addiction
  • Chronic Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-week follow-up visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-week follow-up visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post-surgical Hydromorphone Patient Care Assistance (PCA) Opioid Utilization
Post-surgical Opioid Utilization Using Electronic Medication Review
Post-surgical Pain Rating Using the Visual Analog Scale (VAS)
+2 more
Secondary outcome measures
Post-surgical Emotional Distress Related to Anxiety
Post-surgical Emotional Distress Related to Depression
Post-surgical Opioid Analgesic Efficacy Using the Cold-Pressor Pain Sensitivity Test
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ketamine GroupExperimental Treatment1 Intervention
Participants will receive a 1 mg/kg dose of intravenous ketamine 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure).
Group II: Placebo GroupPlacebo Group1 Intervention
Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1090

Find a Location

Who is running the clinical trial?

Jacques E. ChellyLead Sponsor
8 Previous Clinical Trials
645 Total Patients Enrolled
Jacques E Chelly, MDPrincipal InvestigatorUniversity of Pittsburgh
5 Previous Clinical Trials
279 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the foremost aims of this inquiry?

"The primary measure of this clinical trial's efficacy over 72 hours post-dose is Post-surgical opioid utilization determined by electronic medication review. Secondary measures include a Pre-surgical emotional distress related to depression assessment using the PROMIS Emotional Distress-Depression Short Form questionnaire (scalable from 8, least severe, to 40 most severe), Pain Catastrophizing Scale (from 0 - 56) rating pre-surgery pain experienced in the past 14 days, and finally an evaluation of anxiety levels through the PROMIS Emotional Distress Anxiety Short Form questionnaire ranging from 7 - 35."

Answered by AI

Is the age limit for participation in this investigation lower than sixty years?

"This medical trial requires that prospective participants are aged between 18 and 70. Those younger than 18 can join 63 other studies, while those older than 65 have 649 clinical trials available to them."

Answered by AI

How extensive is the participant base for this experiment?

"Affirmative. Clinicaltrials.gov lists this medical trial as actively searching for test subjects, with the original posting date being December 17th 2019 and the most recent edit occurring on December 3rd 2021. 20 participants need to be recruited across a single site."

Answered by AI

To what degree is Ketamine hazardous for individuals?

"Taking all available evidence into account, our team has assigned Ketamine a rating of 2 due to the Phase 2 trial data that suggests safety but is lacking in efficacy."

Answered by AI

Is this research experiment currently enrolling participants?

"Affirmative. Clinicaltrials.gov documents show that this research initiative, which was originally launched on December 17th 2019, is actively seeking participants to join the trial. 20 individuals are required at a single location for successful completion of the study."

Answered by AI

Who meets the criteria to be eligible for enrollment in this clinical trial?

"This clinical trial is open to 20 volunteers in the 18-70 age range who suffer from chronic pain. Criteria for selection includes those undergoing lumbar, thoracic or cervical spine surgery of a maximum 6 levels and patients with backache that has persisted longer than three months."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Jacques E Chelly, MD
What portion of applicants met pre-screening criteria?
Did not meet criteria
~0 spots leftby Apr 2025