Baltimore, MDNCT06656702Now EnrollingIRB Ready

Amyotrophic Lateral Sclerosis Clinical Trial in Baltimore, MD

Access cutting-edge amyotrophic lateral sclerosis treatment through this early phase 1 clinical trial at a research site in Baltimore. Study-provided care at no cost to qualified participants.

Sponsored by Johns Hopkins University

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Expert Care in Baltimore

Access amyotrophic lateral sclerosis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related amyotrophic lateral sclerosis treatment provided free

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Check if you qualify for this amyotrophic lateral sclerosis clinical trial in Baltimore, MD

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Why Participate?

  • No-Cost Study Care

  • Local to Baltimore

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Baltimore site if eligible
  4. 4Begin participation

About This Amyotrophic Lateral Sclerosis Study in Baltimore

This study aims to study the feasibility of psilocybin therapy for patients with Amyotropic Lateral Sclerosis (ALS) with depressed mood. The secondary objective is to assess its impact on depression, quality of life, hopelessness, and functional status in this patient population.

Sponsor: Johns Hopkins University

Who Can Participate

Inclusion Criteria

Patients aged 18 years and older.
Patients must fulfill ALS El Escorial criteria for possible, probable, laboratory supported probable or definite ALS.
Patients with a pulmonary forced vital capacity (FVC) \>60%. The investigators have chosen this measure of function to account for respiratory decompensation during the 6-month longitudinal portion of the study.
Patients with ability to swallow tablets by mouth. Participants may have a feeding tube, but must be able to swallow by mouth and cannot use the feeding tube to administer the psilocybin tablet.
Clinically significant depressive symptoms as evidenced by an Assessment of Depression Inventory (ADI)-12 score \>22.

Exclusion Criteria

Patients with severe speech impairments, including those who are nonverbal, require assisted speech devices, and those who can only communicate by writing or texting.
Patients who are unable to consent for themselves.
Patients with tracheostomy or continuous continuous positive airway pressure (CPAP) or BiPAP.
Known clinical evidence of frontotemporal dementia.
Cardiovascular conditions: corrected QT interval (QTc) \>450 msec, uncontrolled hypertension (i.e., systolic blood pressure (SBP)\> 139 mm Hg, diastolic blood pressure (DBP)\> 89 mm Hg), resting heart rate (HR)\> 90 beats per minute, angina, a clinically significant ECG abnormality (e.g., atrial fibrillation), transient ischemic attack (TIA) in the last 6 months, stroke, peripheral or pulmonary vascular disease (no active claudication).
Epilepsy with history of seizures
Renal disease (creatinine clearance \<40 ml/min using the Cockraft and Gault equation)
Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
Females who are pregnant (positive pregnancy test) or nursing, or are not practicing an effective means of birth control (i.e., intrauterine systems/devices, hormonal methods including implant, shot, patch, ring, or oral contraceptive, condom, diaphragm, sterilization, and abstinence).
Currently taking medications that interact with psilocybin on a regular (e.g., daily) basis: Atypical antidepressants, such as mirtazapine (Remeron), trazodone (Oleptro), vortioxetine (Brintellix), and vilazodone (Viibryd); Tricyclic antidepressants, such as amitriptyline, imipramine (Tofranil), nortriptyline (Pamelor), desipramine (Norpramin), doxepin, trimipramine (Surmontil), and protriptyline (Vivactil); and Monoamine oxidase inhibitors (MAOIs), such as Selegiline (Emsam), tranylcypromine (Parnate), phenelzine (Nardil) and isocarboxazid (Marplan).
Currently taking Nuedexta (dextromethorphan/quinidine combination), efavirenz, Acetaldehyde dehydrogenase inhibitors such as disulfiram (Antabuse), Alcohol dehydrogenase inhibitors, or UGT1A9 inhibitors or UGT1A10 inhibitors such as phenytoin, regorafenib, eltrombopag.
Current or history of meeting Diagnostic and Statistical Manual (DSM)-5 criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I Disorder
Have a first degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a 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 Baltimore?

Yes, this clinical trial (NCT06656702) has an active research site in Baltimore, MD 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.

Amyotrophic Lateral Sclerosis Treatment Options in Baltimore, MD

If you're searching for amyotrophic lateral sclerosis treatment options in Baltimore, MD, this clinical trial (NCT06656702) 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 Baltimore research site is actively enrolling participants for this early phase 1 clinical trial. You'll receive care from experienced amyotrophic lateral sclerosis 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 amyotrophic lateral sclerosis clinical trials near you to find additional studies recruiting in your area.

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