Ketamine Assisted Psychotherapy for Treating... — Clinical Trial Details

This pilot randomised parallel-group trial (n=30) will assess feasibility and tolerability of combining brief intravenous ketamine treatment with mindfulness-based cognitive therapy (MBCT) versus MBCT alone in adults with chronic pain and PTSD.

The active arm receives four 40-minute IV ketamine infusions (0.5 mg/kg) administered twice weekly over two weeks alongside an 8-week MBCT programme; the comparator arm receives MBCT alone (8 weekly 2-hour online sessions and daily home practice).

Primary objectives are feasibility of trial procedures and tolerability of ketamine; outcomes include quality of life, pain, disability, depressive and PTSD symptoms, and safety signals to inform a future full trial.

Participants

Ages

18 – 64

Sexes

Male & Female

BMI

Psychosis History

Inclusion Criteria

Inclusion Criteria:
i) A current DSM-5 diagnosis of PTSD (confirmed by the Mini International Neuropsychiatric Interview)
ii) Chronic pain (> 4/10 average pain reported for longer than 3 months).
iii) 18-65 years of age.
iv) Capacity to consent.

Exclusion Criteria

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.
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.
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.

Company

Product

Legal

Ketamine Assisted Psychotherapy for Treating Comorbid Chronic Pain and PTSD

Detailed Description

Study Protocol

Preparation

Dosing

Integration

Therapeutic Protocol

Study Arms & Interventions

KAP

Interventions

MT

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators