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Phase 3 Completed N=41 Randomized Double-blind Treatment

Ketamine Infusion for Comorbid PTSD and Chronic Pain

Source: ClinicalTrials.gov NCT04322968 ↗
Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Impact of Event Scale-Revised (IES-R) — 36.33333333; 37; 10.44444444; 15.64705882 units on a scale
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Impact of Event Scale-Revised (IES-R)
28.22; 33.66666667; 11.44; 13.41
PRIMARY
Visual Analogue Scale (VAS)
48.22; 52.88; 43.33; 48.23
SECONDARY
Impact of Event Scale-Revised (IES-R)
28.22; 33.66666667; 11.44; 13.41
SECONDARY
Visual Analogue Scale (VAS)
48.22; 52.88; 43.33; 48.23
SECONDARY
Brief Pain Inventory (Short Form)
38.62; 25.66; 9.62; 28.33; 20.75; 14.66

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04322968). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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