Connectivity Changes Associated With Ketamine Assisted Psychotherapy for PTSD
This single-arm, open-label trial (n=14) will investigate the effects of Ketamine Assisted Psychotherapy (KAP) on individuals with Post Traumatic Stress Disorder (PTSD).
Detailed Description
This prospective, single-group study will enrol 14 adults with PTSD to evaluate clinical and resting-state fMRI connectivity changes associated with Ketamine Assisted Psychotherapy (KAP). Each participant receives two full KAP cycles, each comprising a preparatory session, an intramuscular ketamine administration, and an integration session.
Participants undergo baseline rsfMRI and behavioral assessment, rsfMRI within ~24 hours after each KAP treatment and again ~2 weeks after the second KAP; clinical measures of PTSD symptoms will be correlated with connectivity changes.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
KAP
experimentalKetamine Assisted Psychotherapy: preparatory session, IM ketamine treatment, integration session; two complete KAP cycles per participant.
Interventions
- Ketaminevia IM• single dose• 2 doses total
IM ketamine administered during each of two KAP treatment sessions; paired with preparatory and integration psychotherapy.
Participants
Inclusion Criteria
- Inclusion Criteria:
- Between the ages of 18 to 65 years old.
- Meet DSM-5 criteria for Post-Traumatic Stress Disorder (PTSD) based on clinical interview.
- Able to provide informed consent.
- Are proficient in reading and speaking English.
- Agree to refrain from using stimulants during the day of the medication session.
- Agree to refrain from alcohol and cannabis for 24 hours before and the day of medication session.
- Subjects taking other psychotropic medications must be maintained on a stable dose for at least four weeks before study initiation.
- Agree to not operate a car or any other heavy equipment for the rest of the day after the ketamine administration.
- If necessary, are willing to be contacted via telephone on a daily basis by the therapist or team after each experiential session.
- Able to identify one or two caregiver support persons who can drive participant home, stay with them overnight, be reached by the team, and provide collateral information as needed.
- Willing to inform the investigator within 48 hours if any medical conditions occur or procedures are planned.
Exclusion Criteria
- Exclusion Criteria:
- Considered an immediate suicide risk by clinician assessment or felt to be likely to require hospitalization during the study.
- Psychiatric or medical hospitalization, or an Emergency Department visit, within four weeks of study entry.
- Meet DSM-5 criteria for current bipolar disorder based on clinical interview.
- Meet DSM-5 criteria for current or history of psychotic spectrum disorders based on clinical interview.
- Meeting DSM-5 criteria for current substance use disorder (not in early or sustained remission) other than tobacco use disorder.
- Report use of ketamine >20 times in the past or meet DSM-5 criteria for Other Hallucinogen Use Disorder due to ketamine use, including current early or sustained remission.
- Women who are pregnant or nursing, and women who do not consent to use methods of highly effective birth control during the study.
- Hypertension defined as baseline SBP >140 mmHg or DBP >90 mmHg.
- History of allergic or other adverse reaction to ketamine (or its excipients).
- Clinically significant physical exam findings or medical conditions for which a transient increase in blood pressure could be significantly detrimental (e.g., glaucoma, aneurysmal disease, cardiovascular disease, end-stage renal disease).
- QTc 450 ms or longer on screening.
- High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support).
- Documented significant renal or hepatic dysfunction at screening per protocol-defined thresholds.
- Blood pressure must be ≤140/90 mmHg at safety screening on day of drug administration sessions.