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Ketamine Infusion for Comorbid PTSD and Chronic Pain

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ClinicalTrials.gov Identifier: NCT04322968
Recruitment Status : Completed
First Posted : March 26, 2020
Results First Posted : December 22, 2020
Last Update Posted : December 22, 2020
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
VA Ann Arbor Healthcare System

Tracking Information
First Submitted Date  ICMJE March 24, 2020
First Posted Date  ICMJE March 26, 2020
Results First Submitted Date  ICMJE October 12, 2020
Results First Posted Date  ICMJE December 22, 2020
Last Update Posted Date December 22, 2020
Actual Study Start Date  ICMJE January 9, 2018
Actual Primary Completion Date June 4, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2020)
  • Impact of Event Scale-Revised (IES-R) [ Time Frame: 24 hrs post-infusion ]
    Severity of PTSD symptoms; items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88); higher scores mean worse symptoms
  • Visual Analogue Scale (VAS) [ Time Frame: 24 hrs post-infusion ]
    Severity of chronic pain symptoms; using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100; a higher score indicates greater pain intensity.
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2020)
  • Impact of Event Scale-Revised (IES-R) [ Time Frame: 24 hrs post-infusion ]
    Severity of PTSD symptoms
  • Visual Analogue Scale (VAS) [ Time Frame: 24 hrs post-infusion ]
    Severity of chronic pain symptoms
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2020)
  • Impact of Event Scale-Revised (IES-R) [ Time Frame: 1 week post-infusion ]
    Severity of PTSD symptoms; items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88); higher scores mean worse symptoms
  • Visual Analogue Scale (VAS) [ Time Frame: 1 week post-infusion ]
    Severity of chronic pain symptoms; using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100; a higher score indicates greater pain intensity.
  • Brief Pain Inventory (Short Form) [ Time Frame: 1 week post-infusion ]
    Severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week; No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items can be used as measures of pain severity (a range of 0-10, with 10 being worse scores); the arithmetic mean of the seven interference items can be used as a measure of pain interference (a range of 0-10, with 10 being worse scores). The total score is reported for severity items and interference items, which range from 0-40 and 0-70, respectively. Higher values represent worse outcome.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2020)
  • Impact of Event Scale-Revised (IES-R) [ Time Frame: 1 week post-infusion ]
    Severity of PTSD symptoms
  • Visual Analogue Scale (VAS) [ Time Frame: 1 week post-infusion ]
    Severity of chronic pain symptoms
  • Brief Pain Inventory (Short Form) [ Time Frame: 1 week post-infusion ]
    Severity of chronic pain symptoms
Current Other Pre-specified Outcome Measures
 (submitted: March 30, 2020)
  • Patient-Rated Inventory of Side Effects (PRISE20) [ Time Frame: baseline-1 week post-infusion ]
    Patient self report used to qualify side effects by identifying and evaluating the tolerability of each symptoms; 20 items; higher scores mean worse side effects
  • Clinician-Administered Dissociative States Scale (CADSS) [ Time Frame: baseline-1 week post-infusion ]
    Dissociative, psychotomimetic, and manic symptoms; 27-item scale with 19 subject-rated items and 8 items scored by an observer; higher scores mean worse present-state dissociative symptomatology
Original Other Pre-specified Outcome Measures
 (submitted: March 24, 2020)
  • Patient-Rated Inventory of Side Effects (PRISE20) [ Time Frame: baseline-1 week post-infusion ]
    Side effects
  • Clinician-Administered Dissociative States Scale (CADSS) [ Time Frame: baseline-1 week post-infusion ]
    Dissociative, psychotomimetic, and manic symptoms
 
Descriptive Information
Brief Title  ICMJE Ketamine Infusion for Comorbid PTSD and Chronic Pain
Official Title  ICMJE Low Dose Ketamine Infusion for Comorbid Posttraumatic Stress Disorder and Chronic Pain Patients
Brief Summary

The purpose of the study is to investigate the effectiveness of low dose IV ketamine infusion in the treatment of patients with PTSD and comorbid chronic pain.

Hypothesis: A single ketamine infusion should be associated with significantly greater reduction in core PTSD symptom levels after the treatment and such an effect is not only due to its analgesic properties but also through unknown mechanism of action that maybe related to NMDA/AMPA receptor modulation.

Detailed Description To date, treatment options (i.e. psychotherapy, antidepressant medications) for patients with PTSD, are relatively few, and considering their limited efficacy, novel therapies have gained interest among researchers and treatment providers alike. Among patients with chronic pain about one third suffer from comorbid PTSD, which further complicates their already challenging pharmacological regimens. Low dose ketamine infusion has shown promise in PTSD, and in treatment of chronic pain, however they have not been studied in comorbid population and under rigorous control conditions. The investigators compared the effects of a single dose of either ketamine (0.5 mg/kg) or ketorolac (15 mg) over a 40-minute of IV infusion in chronic pain patients with and without PTSD, in double blind, randomized study. Measures were collected before, during, 1 day and 7 days after the infusion.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patient with and without PTSD were randomized to receive either ketamine or ketorolac. Single IV infusion of ketamine hydrochloride (0.5 mg/kg) was administered over 40 minutes. Ketorolac 15 mg was reconstituted in 500 cc of normal saline administered over 40 minutes.
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
All study personnel, including rater, patients, and data analysts, were blinded to randomization order. Only the anesthesiologist performing the infusion was not blinded in order to prepare for possible side effects of each medication.
Primary Purpose: Treatment
Condition  ICMJE
  • PTSD
  • Chronic Pain
Intervention  ICMJE Drug: A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.
Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
Study Arms  ICMJE
  • Experimental: Chronic pain with PTSD+IV ketamine infusion
    Intervention: Drug: A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.
  • Active Comparator: Chronic pain with PTSD+IV ketorolac infusion
    Intervention: Drug: A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.
  • Experimental: Chronic pain without PTSD+IV ketamine infusion
    Intervention: Drug: A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.
  • Active Comparator: Chronic pain without PTSD+IV ketorolac infusion
    Intervention: Drug: A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2020)
41
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 4, 2019
Actual Primary Completion Date June 4, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Veterans with chronic pain as defined by having any chronic pain beyond 6 months in duration with and without PTSD diagnoses (participants must meet DSM-V criteria for current post-traumatic stress disorder (PTSD) and have received a diagnosis of PTSD greater than or equal to 3 months prior to assessment); they also will be either free of concomitant use of psychotropic and/or pain medications for at least 6 weeks or on stable doses of those medications within the last 6 weeks prior to randomization and for the duration of the study; if applicable, current frequency and duration of psychotherapy sessions must remain stable for at least 6 weeks prior to beginning of the study.

Exclusion Criteria:

Inability to speak English, inability or unwillingness to provide written informed consent; moderate-to-severe cognitive impairment (Mini-Mental State Examination scores<20 administered by a trained clinician); current or lifetime history of psychotic or bipolar disorder; current bulimia or anorexia nervosa, alcohol abuse or dependence in the previous 3 months; serious unstable medical illness or sleep apnea; HTN, prolonged QT interval, peptic ulcer disease or recent history of GI-bleed, renal insufficiency, active substance use disorder, active suicidal or homicidal ideation on presentation; pregnancy (confirmed by baseline lab test), the initiation of female hormonal treatments within 3 months of screening, or inability or unwillingness to use a medically accepted contraceptive method for the duration of the study.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04322968
Other Study ID Numbers  ICMJE IRB-2017-1015
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Local IRB has conducted informed consent audit for the study and the investigators have been compliant with it.
Responsible Party VA Ann Arbor Healthcare System
Study Sponsor  ICMJE VA Ann Arbor Healthcare System
Collaborators  ICMJE University of Michigan
Investigators  ICMJE Not Provided
PRS Account VA Ann Arbor Healthcare System
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP