TIMBER Therapy + Ketamine for PTSD

N/A

Waitlist Available

Led By Basant Pradhan, MD

Research Sponsored by The Cooper Health System

Eligibility Criteria Checklist

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

Must have

Women must be using a medically accepted reliable means of contraception (oral contraceptive medication etc.) or not be of childbearing potential (i.e., surgically sterile, postmenopausal for at least one year)

Men or women, 21-60 years of age

Must not have

Meet criteria for psychotic disorders, e.g. schizophrenia/schizoaffective disorder

History of one or more seizures without a clear and resolved etiology

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for pcl, change in scores at 25th hour post-infusion compared to the baseline were measured

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Summary

This trial is testing a combination of ketamine and TIMBER therapy to see if it's more effective than TIMBER therapy alone in treating PTSD.

Who is the study for?

Adults aged 21-60 with chronic PTSD, who understand the study and consent to participate. They must meet specific PTSD criteria, have stable medication dosages, and use reliable contraception if applicable. Excluded are those with certain mental or severe physical health issues, history of ketamine misuse, pregnancy or breastfeeding women, and recent substance abuse.

What is being tested?

The trial is testing a combination of TIMBER Psychotherapy with either a single low dose of Ketamine or placebo (saline). The goal is to see if this approach can effectively treat chronic PTSD symptoms by targeting trauma memories using both pharmacological and psychotherapeutic methods in a controlled setting.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects from ketamine may include disorientation, dizziness, nausea, increased blood pressure and heart rate. Psychological effects could be anxiety or changes in mood. Side effects from psychotherapy are generally minimal but can include emotional distress.

Eligibility Criteria

Inclusion Criteria

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

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I am either not able to have children or I am using reliable birth control.

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I am between 21 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a psychotic disorder, like schizophrenia.

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I have had seizures with no known cause.

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I have no major abnormal lab results or physical exam findings.

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My thyroid condition is not currently managed.

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I do not have any serious, unstable illnesses affecting major body systems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for pcl, change in scores at 25th hour post-infusion compared to the baseline were measured

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for pcl, change in scores at 25th hour post-infusion compared to the baseline were measured

This trial's timeline: 3 weeks for screening, Varies for treatment, and for pcl, change in scores at 25th hour post-infusion compared to the baseline were measured for reporting.