Enhancing Week-long Psychological Treatment for PTSD With Ketamine

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05737693
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketamine — DRUG
    Week-long exposure therapy with ketamine infusion on day 2 and 4 of the psychotherapy
  • Midazolam — DRUG
    Week-long exposure therapy with midazolam infusion on day 2 and 4 of the psychotherapy

Study Details

The purpose of this study is to test if the combination of ketamine, vs midazolam, with an intensive trauma-focused psychotherapy will be more effective in relieving post-traumatic stress disorder (PTSD). This week-long treatment has the potential to produce a significant therapeutic effect that otherwise would take months to occur. The study will also focus on learning about the neurophysiological changes produced by the proposed clinical trial.

Key Dates

Start date
Aug 21, 2023
Status verified
May 2025
Primary completion
Aug 1, 2030
Completion
Aug 1, 2031

Study Design

Enrollment
162 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 0.2mg/kg ketamine with psychotherapy
    Two infusions of low dose Ketamine combined with trauma-focused psychotherapy. Low dose ketamine infusion will take place on day 2 and day 4, of the psychotherapy intervention. A physician will oversee and administer the ketamine infusions. A nurse will accompany the subject throughout the study sessions, from the insertion of bilateral cannula for drug infusion and blood sampling, to the recovery following ketamine infusion. Whilst subjects undergo the infusion, their heart rate and blood pressure will be constantly monitored. The participant will receive a steady state of ketamine infusion of 0.2 mg/kg for 40 minutes.
  • Experimental: 0.5mg/kg ketamine with psychotherapy
    2\. Two infusions of Ketamine combined with trauma-focused psychotherapy. Low dose ketamine infusion will take place on day 2 and day 4, of the psychotherapy intervention. A physician will oversee and administer the ketamine infusions. A nurse will accompany the subject throughout the study sessions, from the insertion of bilateral cannula for drug infusion and blood sampling, to the recovery following ketamine infusion. Whilst subjects undergo the infusion, their heart rate and blood pressure will be constantly monitored. The participant will receive a steady state of ketamine infusion of 0.5 mg/kg for 40 minutes.
  • Active Comparator: Midazolam with psychotherapy
    Midazolam combined with trauma-focused psychotherapy. Midazolam infusion procedure will take place on day 2 and day 4, of the psychotherapy intervention. A physician will oversee administer the Midazolam infusions. A nurse will accompany the subject throughout the study sessions, from the insertion of bilateral cannula for drug infusion and blood sampling, to the recovery following midazolam infusion. Whilst subjects undergo the infusion, their heart rate and blood pressure will be constantly monitored. The participant will receive a steady midazolam infusion at a rate 0.045 mg/kg for 40 minutes.

Primary Outcome Measure

Amygdala activation to trauma memory (Phase 1; R61) [ Time Frame: Changes from baseline to 30-day post-treatment in amygdala activation to the trauma memory ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale University School of MedicineNew HavenConnecticut06510
Ilan Harpaz-Rotem, PhD
[email protected]
203-937-4760
Charles Gordon, MA
[email protected]
203-932-5711

Find similar trials in New Haven, CT

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Yale University School of Medicine· New Haven, CT

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