Ketamine Infusion for Comorbid PTSD and Chronic Pain
Condition: PTSD; Chronic Pain
MeSH terms: Chronic Pain
Intervention: A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.
Intervention description: 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.
Intervention MeSH terms: Ketorolac; Ketamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
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.
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: PTSD; chronic pain; ketamine infusion

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.
    

Eligibility criteria:

        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.