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Protocol Details

The Neurobiological Mechanisms of Psilocybin as an Aid in Smoking Cessation

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute on Drug Abuse (NIDA)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 21 Years
Max Age: 65 Years

Referral Letter Required


Population Exclusion(s)

Non-English Speaking;
Adults who are or may become unable to consent;
Pregnant Women


Smoking Cessation;

Recruitment Keyword(s)



Nicotine Dependence

Investigational Drug(s)


Investigational Device(s)



Drug: Transdermal Nicotine Patch
Drug: Psilocybin

Supporting Site

National Institute on Drug Abuse


- Nicotine is the substance in cigarettes that makes smoking so addictive. A natural substance called psilocybin might improve the success of smoking cessation treatment compared to the same treatment without psilocybin. Psilocybin is thought to work by enhancing the treatment experience with personal meaning and spiritual significance which is thought to give people the motivation to remain abstinent. Researchers want to learn more about how psilocybin interacts with brain activity so they can develop better treatments for quitting smoking.


- To study whether psilocybin helps people stop cigarette smoking.


- Smokers ages 21 65 who are right-handed and in good physical and mental health.


- Participants must be enrolled in another protocol. These study visits will be scheduled through that protocol.

- Participants will get training on numbers games and thinking tasks. They will try a mock magnetic resonance imaging (MRI) scanner. This looks, sounds, and feels like a real scanner but doesn t take pictures.

- Participants will have 3 MRI scans. They should not have any alcohol for 24 hours before each scan.

- Before each session, participants will practice the tasks. They may be asked questions about their health, smoking, medicines, and habits. Weight, blood pressure, and pulse may be measured. Participants will be tested for recent smoking and alcohol use by blowing into a machine. They will give a urine sample.

- The MRI scanner is a metal cylinder with a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder and wear a special headset. Participants will see the task information on a computer screen inside the scanner. Participants will get earplugs or headphones for loud knocking noises.

- After each scan, participants will meet with a counselor to assess their nicotine craving and, if they have quit smoking, their risk of relapse. Participants may answer other questions.

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Eligibility to participate in the NIDA protocol requires concurrent enrollment in JHU_NA_00016166. All inclusion/exclusion criteria for JHU_NA_00016166 will be assessed by JHU BPRU staff. The NIDA MAI will approve eligibility for MRI scanning under the NIDA protocol based on the MRI Safety form and other materials collected by JHU BPRU staff during study screening. These documents will be put into CDW.


-21 to 65 years old.

-Be right-handed.

-Have given written informed consent.

-Have a high school level of education.

-Be a daily smoker with multiple unsuccessful previous quit attempts, and report a continued desire to quit smoking.

-Agree to abstain from smoking, caffeine, and alcohol for 24-hours prior to MRI scanning.

-Agree to abstain from smoking for the psilocybin session from 1 hour before psilocybin administration until at least 2 hours after completing the next day s MRI scanning session.

-Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the morning of drug session day. If the volunteer does not routinely consume caffeinated beverages, he or she must agree not to do so on session day.

-Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of psilocybin administration. Exceptions include caffeine and nicotine.

-Agree to participate in a paid sub-study protocol at NIDA IRP that will take approximately 4-6 hours to complete.

-Be healthy as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests.


-Women who are pregnant (positive pregnancy test) or nursing, or are not practicing an effective means of birth control

-Cardiovascular conditions: uncontrolled hypertension, angina, a clinically significant ECG abnormality (e.g., atrial fibrilation), TIA in the last 6 months stroke, peripheral or pulmonary vascular disease

-Epilepsy with history of seizures

-Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia

-Currently taking psychoactive prescription medication on a regular 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 MAO inhibitors. For individuals who have intermittent or PRN 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.

-Have HIV or Syphilis.

-Have any current neurological illnesses including, but not limited to, seizure disorders, frequent migraines or on prophylaxis, multiple sclerosis, movement disorders, history of significant head trauma, or CNS tumor.

-More than 20% outside the upper or lower range of ideal body weight according to Metropolitan Life height and weight table

-Not suitable to undergo an MRI session due to certain implanted devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts), body morphology, or claustrophobia.


-Current or past history of meeting DSM-IV criteria for 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 meeting DSM-IV criteria for alcohol or drug dependence (excluding caffeine and nicotine) or severe major depression.

-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.

-Currently meets DSM-IV criteria for Dissociative Disorder, Anorexia Nervosa, Bulimia Nervosa, or other psychiatric conditions judged to be incompatible with establishment of rapport or safe exposure to psilocybin

Individuals who do not pass screening or choose not to participate will be asked whether they want us to keep their personal contact information using HIPAA-IRB Form 3. Identifiers for those individuals who do not want us to retain their information will be destroyed. We will retain information because we want to be able to summarize the reasons that individuals failed screening or choose not to participate in this study. Also, because the inclusion/exclusion criteria may be changed in our future studies with psilocybin and related compounds, it is possible that excluded volunteers may be eligible for studies in the future.

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Amy Janes, Ph.D.
National Institute on Drug Abuse (NIDA)
NIDA IRP Office of Human Subjects Research
251 Bayview Blvd, Suite 200
Baltimore, Maryland 21224
(667) 312-5164

NIDA IRP Screening Team
National Institute on Drug Abuse (NIDA)

(800) 535-8254

NIDA IRP Screening Team

(800) 535-8254

Clinical Trials Number:


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