Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT07009158
Eligibility Criteria:
Inclusion Criteria:
i) A current DSM-5 diagnosis of PTSD (confirmed by the Mini International Neuropsychiatric Interview (66)) ii) Chronic pain (\> 4/10 average pain reported for longer than 3 months (per (67)).
iii) 18-65 years of age. iv) Capacity to consent
Exclusion Criteria:
i) Currently receiving or received ketamine or psychotherapy to treat PTSD in previous 8 weeks.
ii) Meeting DSM-5 criteria for substance abuse disorder within the past month or lifetime history of ketamine abuse.
iii) Concomitant unstable major medical or neurological conditions, or laboratory/imaging results as considered by the study treating physician to interfere with trial participation (e.g. poorly controlled blood pressure, BMI \>35).
iv) Pregnancy or the intention to become pregnant and breastfeeding during the study as confirmed by self-report. Participants must be willing to use a medically acceptable method of birth control which include abstinence, hormonal (birth control pills, patch, hormone injections or implants), diaphragm with spermicide or cervical cap, IUD, condom used together with spermicide, surgical sterilization (hysterectomy or partner's vasectomy) and post-menopausal more than 2 years.
v) DSM-5 diagnosis of bipolar disorder, psychotic disorder, or a severe personality disorder which may interfere with the trial. Patients with lifelong diagnosis of Bipolar Disorder, Schizophrenia or Schizoaffective disorder will be excluded. Patients with primary Obsessive Compulsive Disorder, Substance Use Disorder (dependence and abuse), Seasonal Affective Disorder, or Generalized Anxiety Disorder at time of assessment will be excluded. Primary severe borderline personality disorder and any other personality disorders that potentially may interfere with treatment administration will also be excluded.
vi) Deemed to be high suicidal risk during the baseline assessment as per treating physician. Chronic persistent suicidality is not an exclusion.
vii) Use of medications that might interfere with ketamine efficacy such as benzodiazepines with a dose equivalent to lorazepam 2mg/day or higher, and anti-convulsant (except for pregabalin and gabapentin).
viii) Deemed not appropriate to engage in group psychotherapy. ix) Inability to communicate in spoken and written English fluently enough to complete the required study assessments or a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete clinical assessments).
x) Cognitive or physical impairment severe enough to interfere with IV ketamine administration and the subject's ability to stay in the same place for a 2-hr monitoring supervision.
xi) Inability to secure a responsible adult to accompany them back home after ketamine sessions.
xii) Inability to take part in virtual care, no valid email address. xiii) Inability to safely secure IV access.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT07009158
Study Brief:
Protocol Section:
NCT07009158