Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Nicotine Addiction
• Age: Between 21 Year(s) - 150 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. 21 years old or older
  2. Be a daily smoker (minimum of 5 cigarettes/day on a typical day) with multiple unsuccessful previous quit attempts, and report a continued desire to quit smoking
  3. Read, write, and speak English
  4. Agree to abstain from smoking for the psilocybin/niacin session from 1 hour before psilocybin/niacin administration until at least 8 hours afterward
  5. Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of psilocybin/niacin administration
  6. Be willing to be screened for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis lab tests

  
  

You may not be eligible for this study if the following are true:

• 1. The use of e-cigarettes or tobacco products other than machine-manufactured combustible cigarettes (e.g., cigarillos) on more than 5 of the previous 30 days
  2. Women who are pregnant (positive pregnancy test) or nursing, or are not practicing an effective means of birth control
  3. Positive urine drug screen for illicit drugs (excluding cannabis)
  4. Positive breath test for alcohol. Participants with positive tests will be rescheduled
  5. Currently taking on a regular basis (e.g., daily) antidepressants of any drug class, antipsychotics, or MAO inhibitors, or serotonin-acting dietary supplements (e.g., 5-hydroxy- tryptophan, St. John’s wort). Currently taking efavirenz, Acetaldehyde dehydrogenase inhibitors such as disulfiram (Antabuse), Alcohol dehydrogenase inhibitors, or UGT1A9 inhibitors or UGT1A10 inhibitors such as phenytoin, regorafenib, eltrombopag. For individuals who have intermittent or “as needed” use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose
  6. Current use of medications for smoking cessation (i.e., varenicline, nicotine replacement products, bupropion)
  7. Current neurological illnesses including, but not limited to, seizure disorders, frequent migraines or on prophylaxis, multiple sclerosis, movement disorders, history of significant head trauma (loss of consciousness > 24 hours), or CNS tumor.
  8. Recent (within the past 12 months) or an extensive history of psychedelic use (>20 lifetime uses)
  9. Current or past history of Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I or II Disorder. Current or past history within the last 5 years of alcohol or drug use disorder (excluding caffeine and nicotine) or severe major depression
  10. Recent (past year) history of suicidal behavior or attempt or current suicidal ideation
  11. Have a first- or second-degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or bipolar I or II disorder
  12. Dissociative Disorder, Anorexia Nervosa, Bulimia Nervosa, Major Depression, or Post-traumatic Stress Disorder
  13. Current weight < 50 kg