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Ketamine Therapy for PTSD (CONCHKAP Trial)

Phase 1 & 2

Waitlist Available

Led By Snehal Bhatt, MD

Research Sponsored by University of New Mexico

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between the ages of 18 to 65 years old.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28-35 days

Awards & highlights

CONCHKAP Trial Summary

This trial will investigate how Ketamine Assisted Psychotherapy affects people with PTSD to see if it improves their symptoms and alters brain activity.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Ketamine may cause side effects such as increased blood pressure during administration which is why individuals with cardiovascular conditions are excluded from the trial. Other potential side effects include dissociation (feeling disconnected from reality), nausea or vomiting.

CONCHKAP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

CONCHKAP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28-35 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28-35 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28-35 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical outcome: PTSD severity

Imaging Outcome: Changes in functional connectivity

Secondary outcome measures

Correlation of clinical and imaging outcomes

Depression severity

Persisting MDD effect

+1 more

Side effects data

From 2020 Phase 4 trial • 75 Patients • NCT03156504

Lightheadedness with low blood pressure

Pump Malfunction

PTSD

100%

80%

60%

40%

20%

Study treatment Arm

Ketamine

CONCHKAP Trial Design

1Treatment groups

Experimental Treatment

Group I: Ketamine Assisted Psychotherapy [KAP]Experimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketamine Hydrochloride

2018

Completed Phase 4

~910

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of New MexicoLead Sponsor

372 Previous Clinical Trials

3,528,789 Total Patients Enrolled

The Mind Research NetworkOTHER

26 Previous Clinical Trials

2,500 Total Patients Enrolled

Snehal Bhatt, MDPrincipal InvestigatorUNM

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment to this clinical trial still open?

"The data stored on clinicaltrials.gov specifies that this trial, which was initially posted October 1st 2023 and last updated September 6th 2023 is no longer seeking participants. Nevertheless, 403 other trials are actively recruiting at the present time."

Answered by AI

Am I eligible to partake in this research study?

"In order to qualify for this trial, potential participants must have a diagnosis of post-traumatic stress disorder and be aged between 18 and 65. There are 14 vacancies available at the moment."

Answered by AI

Does this trial accept individuals aged fifty or older?

"Adults aged 18 to 65 are the only individuals accepted for this clinical trial. Separate medical studies exist that cater to those under and over these age limits, with 39 trials involving minors and 323 devoted to elderly patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Connectivity Changes Associated With Ketamine Assisted Psychotherapy for PTSD

Snehal Bhatt, MD 2023. "Connectivity Changes Associated With Ketamine Assisted Psychotherapy for PTSD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06036511.