Psilocybin Brain Stimulation and Imaging Pilot Study (OPTE)

Johns Hopkins University

Status and phase

Begins enrollment this month

Phase 1

Conditions

Healthy Volunteers

Treatments

Device: TMS

Drug: Psilocybin 25 mgs

Study type

Interventional

Funder types

Other

Identifiers

NCT06835699

IRB00451481

Details and patient eligibility

About

This open-label pilot psilocybin administration study investigates the influence of psilocybin on brain function and cognitive control functions in clinically and psychiatrically healthy volunteers. Participants will undergo experimental drug administration sessions after careful screening and preparation. Participants will also have brain activity measured using electroencephalogram (EEG) also during non-invasive brain stimulation using Transcranial Magnetic Stimulation (TMS).

Enrollment

15 estimated patients

Sex

All

Ages

22 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Have given written informed consent
Right handed
Between the ages of 22 and 55 years old
Have a high school level of education
Be medically healthy and psychologically stable as determined by screening for medical problems via a personal interview, medical history and physical examination, psychiatric interview, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests
Fluent in English and capable of providing informed consent
Willing to remove any jewelry, hair clips, bobby pins, or any other potentially conducting or magnetic objects worn on or near the head
Have a minimum of 2 lifetime uses of a hallucinogen (e.g., Lysergic acid diethylamide (LSD), psilocybin mushrooms, N,N-dimethyltryptamine (DMT), ayahuasca, mescaline, Salvia divinorum, ketamine, dextromethorphan (DXM) , and phencyclidine (PCP). Only psychoactive and recreational use of the hallucinogenic drugs, including dextromethorphan and ketamine, will be factored into the calculation of lifetime use.
Cigarette smokers must agree to abstain from smoking on session days from 1 hour before drug administration
Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of each drug administration. Exceptions include daily use of caffeine and nicotine.
Agree that for one week before each session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except if 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
Agree not to take any "as-needed", pro re nata (PRN) prescription medications on the mornings of the sessions
Agree not to operate dangerous machinery or a motor vehicle for at least 12 hours after leaving the research unit
(for male participants) Agree to use contraception and refrain from sperm donation within two weeks of completing dosing sessions, as the reproductive safety for psilocybin is not yet established. Effective methods of contraception are barrier, hormonal and sterilization methods.
(for female participants) Agree to use highly effective birth control measure within two weeks of completing the dosing sessions. Effective methods of contraception are barrier, hormonal and sterilization methods.

Exclusion criteria

Weight greater than 350 lbs (the weight limit of the specialized TMS/EEG chair)
Weight less than 40 kg
Cardiovascular conditions: coronary artery disease, stroke, angina, hypertension with resting blood pressure systolic >139 or diastolic >89, a clinically significant ECG abnormality (e.g., atrial fibrillation), prolonged corrected QT (QTc) interval (i.e., QTc > 450 msec), artificial heart valve, or Transient Ischemic Attack (TIA) in the past year
Hallucinogen use within the past 6 months (preference given to volunteers who have maintained a longer period of abstinence).
Epilepsy with history of seizures
Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
Current or past history of meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for schizophrenia, psychotic disorder (including of substance-induced but excluding due to a medical condition), dissociative disorder, bipolar I or II disorder, or an eating disorder
Have tinnitus or other hearing problems
Have a first degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or bipolar I or II disorder
Have a first degree relative with a history seizures, epilepsy, or acute spells of unknown origin
Have an intracranial lesion
Have suffered ischemic or hemorrhagic stroke
Currently taking psychoactive prescription medication on a regular (e.g., daily) basis
Currently taking on a regular (e.g., daily) basis any medications having a primary centrally-acting pharmacological effect on serotonin neurons or medications that are monoamine Oxidase (MAO) inhibitors. For individuals who have intermittent or PRN use of such medications, sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose
Currently taking the antiviral drug, efavirenz
Acute intoxication with any drug of abuse, including alcohol or cannabis
Current or past-year substance use disorder
Pregnancy
History of neurological problems, including epilepsy, seizures, syncope, tinnitus, migraine, or frequent non-migraine (e.g. tension) headaches
History of head trauma associated with loss of consciousness
Language or hearing impairment that would undermine communication regarding consent, study procedures, and overall volunteer safety.
Irritable skin
TMS-contraindicated medical devices, including cochlear implants, pacemaker, neurosensory stimulator, implantable defibrillator, insulin pump, clips, stents, or shunts that may be disrupted by or interact with TMS coil operation
Taking medications that lower seizure threshold
MRI contraindications (e.g. claustrophobia incompatible with MRI scanning, medical device or implant incompatible with MRI, prior history as a metal worker and/or certain metallic objects in the body -- must complete MRI screening form and be approved by MRI technologist before the scan