Is NCT06430541 recruiting in Aurora, CO?

Yes, NCT06430541 is currently recruiting participants at its Aurora, CO location. This breast cancer clinical trial is actively enrolling qualified participants.

How do I join the breast cancer clinical trial in Aurora?

To join this clinical trial in Aurora, 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 Aurora 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.

Breast Cancer Clinical Trial in Aurora, CO

About This Breast Cancer Study in Aurora

The goal of this clinical trial is to test whether psilocybin along with therapy in women with early breast cancer and ovarian cancer in remission can improve their fear of recurrence. The main question\[s\] it aims to answer \[is/are\]: Does psilocybin assisted therapy improve fear of cancer recurrence? Does psilocybin assisted therapy improve anxiety, depression, and quality of life? Participants will complete a series of survey measures, participate in preparatory therapy. After prep therapy is complete, they will receive a moderately high dose of psilocybin in a monitored and supportive environment. After the dosing day, they will complete 4 sessions of integrative therapy and complete survey measures.

Sponsor: University of Colorado, Denver

Who Can Participate

Inclusion Criteria

1, Aged ≥ 21 2. Diagnosis of:

early-stage breast cancer at low risk of recurrence

defined as clinical stage 1 or 2

completed primary treatment (surgery, chemotherapy \[adjuvant, patients may continue to be treated with neoadjuvant\], and/or radiation) \> 6 months ago

oncologist reported risk of recurrence at 10 years \< 20%

late-stage ovarian cancer at high risk of recurrence

defined as Clinical stage 3 or 4

currently in remission

oncologist reported risk of recurrence at 10 years \> 80% 2. Functional Status defined as:

Eastern Cooperative Oncology Group (ECOG) ≤1

Palliative Performance Scale (PPS) ≥60%

Ability to tolerate PO medication administration 4. Fear of recurrence at screening and baseline 5. Have an identified support person

Agree to be accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing 6. Participants of childbearing potential must agree to practice an effective means of birth control throughout the duration of the study.

Exclusion Criteria

Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or EKG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include:

Congestive heart failure

Valvular heart disease

Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant EKG abnormality (i.e., QTC interval \> 450)

Recent acute myocardial infarction or evidence of ischemia

Malignant hypertension

Congenital long QT syndrome

Acute renal failure

Severe hepatic impairment

Respiratory failure

eGFR \< 50 mL/min/1.73m2

LFTs \> 1.5 x ULN

WBC \< 5 x 10\*9/L

Hemoglobin \< 8.0 g/dL

Platelets \< 150 x 10\*9/L

Risk for hypertensive crisis defined as: Screening and Baseline blood pressure \>140/90 mmHg

Significant central nervous system (CNS) pathology Examples include:

Primary or secondary cerebral neoplasm

History of stroke

Cerebral aneurysm

Primary psychotic or affective psychotic disorders Examples include current or past DSM-5 criteria for:

Schizophrenia spectrum disorders

Schizoaffective disorder

Bipolar I or bipolar II disorder

Major Depressive Disorder with psychotic features

Prior history of psychosis due to medical condition or substance use

Family history of psychotic or serious bipolar spectrum illnesses. Examples include first-degree relative with:

Schizophrenia spectrum disorders

Schizoaffective disorder

Bipolar I disorder with psychotic features

High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation and judgement. Examples include:

Violent behavior

Active substance use disorders (SUDs) defined as:

DSM-5 criteria for moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine) within the past year

DAST-10 score of 3 or higher

Two or more "yes" responses to CAGE screening questionnaire

Extensive use of serotonergic hallucinogens (e.g., LSD, psilocybin) defined as:

Any use in the last 12 months

\>25 lifetime uses

Clinically significant suicidality or high risk of completed suicide defined as:

'Yes' to C-SSRS Suicidal Ideation items 4 or 5 within the last 2 months at Screening or 'since last visit' at Baseline

Any C-SSRS Suicidal Behavior item within the past 12 months at Screening or 'since last visit' at Baseline, as defined by 'Yes' to any of the following on the C-SSRS: actual attempt, interrupted attempt, aborted attempt, or preparatory acts

Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self-injurious behavior

History of hallucinogen persisting perception disorder (HPPD)

Pregnancy/lactation

Cognitive impairment as defined by: • Montreal Cognitive Assessment Test (MoCA) \< 23

Concurrent Medications

Antidepressants

Centrally-acting serotonergic agents (e.g., MAO inhibitors)

Serotonin-acting dietary supplements (such as 5-hydroxy-tryptophan or St. John's wort)

Antipsychotics (e.g., first and second generation)

Mood stabilizers (e.g., lithium, valproic acid)

Aldehyde dehydrogenase inhibitors (e.g., disulfiram)

Significant inhibitors of UGT 1A0 or UGT 1A10

Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone) unless prescribed, and Phencyclidine (PCP).

Have a psychiatric condition judged to be incompatible with establishment of rapport with the study therapists or safe exposure to psilocybin

Have any psychological or physical symptom, medication, or other relevant finding , based on the clinical judgment of the PI or relevant clinical study staff that would make a participant unsuitable for the study.

Have an allergy or intolerance to any of the materials contained in the drug product

Non-English speaking individual

Be enrolled in another clinical trial assessing intervention(s) for anxiety, depression, and/or existential distress (e.g., pharmacologic or psychotherapeutic interventions)

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 Aurora?

Yes, this clinical trial (NCT06430541) has an active research site in Aurora, CO 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.

Breast Cancer Treatment Options in Aurora, CO

If you're searching for breast cancer treatment options in Aurora, CO, this clinical trial (NCT06430541) 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 Aurora research site is actively enrolling participants for this clinical trial. You'll receive care from experienced breast cancer 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 breast cancer clinical trials near you to find additional studies recruiting in your area.

Breast Cancer Clinical Trial in Aurora, CO

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