Is NCT06724289 recruiting in Charlottesville, VA?

Yes, NCT06724289 is currently recruiting participants at its Charlottesville, VA location. This prolonged grief disorder clinical trial is actively enrolling qualified participants.

How do I join the prolonged grief disorder clinical trial in Charlottesville?

To join this clinical trial in Charlottesville, 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 Charlottesville 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.

Prolonged Grief Disorder Clinical Trial in Charlottesville, VA

Who Can Participate

Inclusion Criteria

Ages 18 years old up to and including 65 years of age

Negative UDS results for illicit drugs at screening and prior to each drug administration session

Consent to all study procedures

Have an existing diagnosis of Prolonged Grief Disorder. May also be determined to have Complicated Grief Disorder without official diagnosis as determined by PI or designate based on DSM V criteria

Score of greater than 25 on the Inventory of Complicated Grief

Agree to abstain from any psychoactive drugs on the day prior to and the day of the drug administration session

People of childbearing potential that are sexually active must agree to continue or initiate practice of a highly effective means of birth control, alone or in combination with another, throughout the study. Highly effective options are: implants, intrauterine devices (IUD), and sterilization. Exclusive use of condoms is not effective.

Be judged by study team clinicians to be at low risk for suicidality as determined by MINI, Columbia Suicide Severity Scale, and the Patient Health Questionnaire-9.

Concurrent psychotherapy or pharmacotherapy with SSRIs, SNRIs, and/or bupropion (\< 300 mg bupropion) is allowed if the type and frequency of the therapy has been stable for at least two months prior to screening and is expected to remain stable during participation in the study

Be otherwise medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), urine beta-HCG, and urine toxicology screen

Participant must agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that they consume on a usual morning, before arriving at the research unit on the mornings of drug session days. If the participant does not routinely consume caffeinated beverages, they must agree not to do so on session days

Agree not to take any PRN medications on the mornings of drug sessions

Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration

Agree that for one week before each drug session, participant will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals

Willingness and ability to remain within the observation room for the duration of the study visits up to 10 hours

Willingness and ability to follow study protocol as directed by research staff

Willing and able to attend all sessions in the study and complete follow up assessments

Fluent in English

Ability to provide one photo of a deceased loved one and one photo of a living loved one, as required for the grief elicitation task.

Exclusion Criteria

General medical exclusion criteria:

Previous use of a psychedelic drug may be exclusionary depending on frequency, context, and participant safety as determined by the PI or designate.

Person who is pregnant, nursing, or planning to get pregnant determined at screening and before drug session by urine test or self-report

People of childbearing potential that are sexually active who are not practicing an effective means of birth control

Cardiovascular conditions: coronary artery disease, stroke, angina, a clinically significant ECG abnormality (e.g., atrial fibrillation), prolonged QTc interval (i.e., QTc \> 450 msec), heart valve, or TIA in the past year.

History of head trauma with neurological deficit; seizures, or neurologic disorders including cerebrovascular disease, epilepsy, or neurogenerative diseases

Type 1 diabetes

Currently taking on a regular (e.g., daily) basis any antidepressant medications other than SSRIs, SNRIs, or bupropion, or any other medications that have a primary centrally-acting serotonergic effect, including MAOIs. Bupropion dosage must be \< 300 mg in order to be included

Nicotine dependence that would be incompatible with remaining in study area for the entirety of the visit

Prescribed or illicit use of benzodiazepines or opioids within 4 weeks prior to screening

Baseline blood pressure greater than 139/79 (after repeat measures) unless stable with medication as determined by PI or PI designate

Taking any muscle relaxers, antihistamines, or other medications known to cause lethargy or impair cognitive ability within one day prior to psilocybin session

Serious medical comorbidity requiring medical intervention or close supervision

History of claustrophobia

Any court mandated or legal restrictions that would impair the participant from attending all visits

Inability to follow and comply with all study procedures

Deemed unable to meaningfully or safely participate in the study

Any legal judgement toward subject determined to interfere with study attendance or jeopardize compliance with study protocol determined by PI or designate

Individuals who are unable to undergo MRI as determined by MRI pre-screening. General psychiatric exclusion criteria:

Score of less than 25 on the Inventory of Complicated Grief

Severe psychiatric disorder (other than depression) within 6 months or lifetime history of serious psychiatric or neurological disorders, including bipolar disorder, or active psychosis

Clinically significant suicidal ideation (e.g., with strong intent or means) within past 6 months or lifetime history of suicide attempt based on the MINI, Patient Health Questionnaire-9 or Columbia-Suicide Severity Scale. At any point during the study, a participant may be withdrawn from the study for concerns of suicidality and provided follow-up care by our team or a referral to care if needed.

Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders, or bipolar I disorder

Current or previous history within one year of meeting DSM-5 criteria for a moderate or severe alcohol, or other drug use disorder (excluding tobacco, caffeine, and cannabis)

Nicotine dependence that would be incompatible with an individual to be nicotine free for 8-10 hours on a psilocybin session day

Have a first degree relative with schizophrenia or other psychotic disorders (except substance/medication-induced or due to another medical condition), or bipolar I disorder

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 Charlottesville?

Yes, this clinical trial (NCT06724289) has an active research site in Charlottesville, VA 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.

Prolonged Grief Disorder Treatment Options in Charlottesville, VA

If you're searching for prolonged grief disorder treatment options in Charlottesville, VA, this clinical trial (NCT06724289) 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 Charlottesville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced prolonged grief disorder 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 prolonged grief disorder clinical trials near you to find additional studies recruiting in your area.

Prolonged Grief Disorder Clinical Trial in Charlottesville, VA

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About This Prolonged Grief Disorder Study in Charlottesville