Is NCT05269459 recruiting in Omaha, NE?

Yes, NCT05269459 is currently recruiting participants at its Omaha, NE location. This ptsd clinical trial is actively enrolling qualified participants.

How do I join the ptsd clinical trial in Omaha?

To join this clinical trial in Omaha, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Omaha clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

PTSD Clinical Trial in Omaha, NE

About This PTSD Study in Omaha

Post-traumatic stress disorder (PTSD) is a psychiatric disorder than may develop following a traumatic event including serious incidents, natural or human-caused disasters, violence, death of a loved one, receipt of traumatic news, or serious illness/hospitalization. While half of US adults experience trauma in their lifetime, most do not develop PTSD. However, those who do develop the disorder may have significant impairments and risk for functional dysfunction across multiple domains. While short term symptoms are the most common, some individuals develop chronic PTSD. These individuals may experience frightening and intrusive thoughts and memories of the event (flashbacks), have sleep disturbances, feel numb or detached, and be easily startled (hypervigilance). This trial is a double-blind placebo controlled study of cannabidiol (CBD) for symptoms of PTSD in adults using liquid structure Formulation (Nantheia ATL5). Participants complete three weeks of baseline data collection including assessments of activity and sleep. Intervention is Nantheia ATL5 or placebo. Dose is initiated at 400mg BID and maintained over 8 weeks. Standardized symptom profile measurements, clinician assessments, laboratory testing, collection of inflammatory biomarkers, and suicide screening is completed throughout. Age- and gender-matched healthy population participants are enrolled and complete baseline data collection only. All participants may complete optional functional magnetic resonance imaging (fMRI).

Sponsor: University of Nebraska

Who Can Participate

Inclusion Criteria

All Participants

Ability and willingness to provide informed consent

Stated willingness to comply with all study procedures and availability for duration of the study

Aged 21-65 years

Able to read and communicate in English

Tetrahydrocannabinol (THC) use less than 3 days per week PTSD Participants

Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for a current diagnosis of Post-Traumatic Stress Disorder (PTSD) on the Mini-Mental State examination (MMS), with symptoms present for at least 1 month

Clinician administered Clinical Assessment of Pragmatics (CAPs) score ≥27 at study enrollment and start of Cannabidiol (CBD) observation

Stable psychopharmacologic and/or psychotherapeutic intervention for 4 weeks prior to enrollment

Exclusion Criteria

All Participants

Current use of prescribed or commercially available CBD products, including Epidiolex®

Suicidal ideation (as defined by answer of "yes" to item 4 or 5 on the baseline Columbia Suicide Severity Rating Scale (C-SSRS) or attempt within 6 months prior to enrollment)

Cognitive impairment in the clinical judgment of the investigator that would impact ability to complete study assessments or confound study results (e.g., neurodegenerative condition or other)

Meets criteria for substance or alcohol use disorder of moderate or greater severity within 6 months prior to study enrollment based on the Mini-Mental State examination (MMS); nicotine dependence permitted

Self-reported cannabis use on \> 3 days/week starting 4 weeks prior to enrollment

Positive urine drug screen for illicit substances other than cannabis

Pregnant \[confirmed by serum human chorionic gonadotropin (hCG) test\], or breastfeeding

Co-morbid medical conditions or concomitant treatments that may adversely impact ability to participate in the trial in the clinical judgment of the investigator \[e.g., significant immunosuppression due to active chemotherapy, recent organ transplant, uncontrolled diabetes, glomerular filtration rate (GFR) \< 25ml/min or on dialysis, recent acute myocardial infarction (MI), Class IV heart failure, or taking any high-risk drugs for drug-drug interactions\]

Treatment with another investigational drug or other intervention within 3 months prior to enrollment

History of psychosis (schizophrenia, schizophreniform disorder, schizoaffective disorder, or substance induced psychosis), active bipolar disorder, or borderline personality disorder diagnosed by a mental health professional

History of open head injury

Self-report of exposure to trauma within 30 days prior to enrollment

Active military service in the 30 days prior to enrollment

Inpatient psychiatric hospitalization within 6 months prior to enrollment

Seizure in the last 6 months

Use of concomitant anti-viral human immunodeficiency virus (HIV) medications (PrEP permitted) Control Participants

History of diagnosed PTSD

Pregnant (self-reported) or breastfeeding Participants who consent to functional magnetic resonance imaging (fMRI) procedures

Claustrophobia, pregnancy, or any condition (e.g., significant hearing difficulties) that would preclude MRI scanning, in the clinical judgment of the investigator

Presence of metal objects in or on the body (e.g., pacemakers, aneurysm clips, metallic prostheses, bone plates, braces, orthodontic devices, cochlear implants/hearing aids, non-removable piercings/implants or metallic-ink tattoos, or shrapnel fragments)

Other confounding medical conditions (e.g., Tourette's or Tic Disorder) that would preclude MRI scanning, in the clinical judgement of the investigator PTSD Participants

Index trauma before age 18 and no other traumatic experiences which could relate/identify as part of PTSD

History of allergic reaction or significant adverse events (AE) related to cannabis, CBD, or THC

Currently involved in events giving rise to PTSD

Alanine transaminase (ALT)/Aspartate transaminase (AST)/Bilirubin \> 2 x upper limit of normal (ULN) at screening (abnormalities on the comprehensive metabolic panel or complete blood count deemed to be of clinical significance in the judgement of the investigator and clinical team will be evaluated in the clinical context of the participant's history and physical examination to determine eligibility and testing may be repeated if clinically appropriate at the discretion of the investigator)

Refusal to use at least one form of birth control throughout study participation \[including, but are not limited to, male or female condoms, diaphragm, or cervical cap (all with or without spermicide) abstinence, or hormonal/implanted birth control, e.g., pill, injection, intra-uterine device (IUD), implant\] by participants who can become pregnant

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Omaha?

Yes, this clinical trial (NCT05269459) has an active research site in Omaha, NE that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

PTSD Treatment Options in Omaha, NE

If you're searching for ptsd treatment options in Omaha, NE, this clinical trial (NCT05269459) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Omaha research site is actively enrolling participants for this clinical trial. You'll receive care from experienced ptsd specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all ptsd clinical trials near you to find additional studies recruiting in your area.

PTSD Clinical Trial in Omaha, NE

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