Ketamine Therapy for PTSD

(CONCHKAP Trial)

Overseen by Snehal Bhatt, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of New Mexico

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn about the effects of Ketamine Assisted Psychotherapy \[KAP\] on individuals with Post Traumatic Stress Disorder \[PTSD\]. The main questions it aims to answer are: 1. Does KAP improve symptoms of PTSD? 2. What changes in brain network connectivity are seen with KAP?

Research Team

Snehal Bhatt, MD

Principal Investigator

UNM

Eligibility Criteria

This trial is for adults aged 18-65 with PTSD who can consent and communicate in English. They must avoid alcohol, cannabis, and stimulants on session days, have stable psychotropic medication doses if applicable, not drive post-session, and have a support person available. Excluded are those at suicide risk, recent hospital visits, substance use disorders (except tobacco), pregnant/nursing women without birth control agreement, high blood pressure or heart issues, liver/renal dysfunction, bipolar or psychotic spectrum disorders history.

Inclusion Criteria

Are proficient in reading and speaking English.

Willing to inform the investigator within 48 hours if any medical conditions occur or procedures are planned.

You have been diagnosed with Post-Traumatic Stress Disorder (PTSD) by a doctor after a clinical interview.

Exclusion Criteria

They are considered an immediate suicide risk by clinician assessment or felt to be likely to require hospitalization during the study.

High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support).

I have a condition like glaucoma or heart disease where high blood pressure could be harmful.

Treatment Details

Interventions

• Ketamine Assisted Psychotherapy (Other)

Trial Overview The study examines Ketamine Assisted Psychotherapy's impact on PTSD symptoms and brain connectivity changes. Participants will undergo sessions where they receive ketamine hydrochloride while engaging in psychotherapy to determine its effectiveness in treating their condition.

Participant Groups

Group I: Ketamine Assisted Psychotherapy [KAP] Experimental Treatment 1 Intervention

A total of 14 adult patients with PTSD will be recruited from UNM outpatient clinics and undergo rsfMRI and behavioral assessment prior to ketamine treatment. They will complete baseline scan at day one, a preparatory session (initial part of KAP), IM ketamine treatment, then within 24 hours, an integration session to take advantage of neuroplasticity for optimal therapeutic progress. Each participant will have two complete KAP sessions (preparation, treatment, and integration) followed by rsfMRI within approximately 24 hours, and again approximately two weeks after the completion of the second KAP session. Patients will also have repeat clinical assessments after each treatment. Changes in PTSD symptoms will be correlated with changes in connectivity at each rsfMRI.

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

Lisa Kuuttila

University of New Mexico

Chief Executive Officer since 2013

PhD in Pharmaceutical Sciences

David L. Perkins

University of New Mexico

Chief Medical Officer since 2015

MD, PhD

The Mind Research Network

Collaborator

Trials

27

Recruited

2,300+