AnxietyPhase 1/2NCT00302744
Effects of Psilocybin in Advanced-Stage Cancer Patients With Anxiety
A Phase 1/2 study testing Psilocybin (drug), Niacin and MRI in people with Anxiety, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
Trial summary
Psychiatric Research Study For Cancer Patients The Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center is conducting a study designed to measure the effectiveness of the novel psychoactive medication psilocybin on the reduction of anxiety, depression, and physical pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Psilocybin (drug), Niacin and MRI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Dec 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have advanced-stage cancer and anxiety.
- Be between the ages of 18 - 70.
- Note: The location for the two treatment sessions is Los Angeles, California. Treatment sessions are scheduled three to six weeks apart, and they include one overnight hospital stay both times.
Who cannot join
- Not have cancer that affects the central nervous system or brain function.
- Have no history of major psychiatric disorder.
- Have no kidney disease, abnormal liver functions, epilepsy, or cardiovascular disease, including untreated hypertension.
- Not be taking insulin, oral hypoglycemic, anti-seizure, or cardiovascular medications (except anti-hypertensive drugs).
- May take PRN benzodiazepines up to 3 days before the session.
- No Prozac for the previous 5 weeks.
Show all 9Show fewer
- No medications the day of and the day after treatment sessions, except may take ongoing adjuvant chemotherapy as prescribed, prescribed or over-the-counter non-narcotic pain medication at any time, and narcotic pain medications up to eight hours before administration of psilocybin and six hours after administration.
- No alcohol consumption the day before, the day of, and the day after a session.
- Female subjects of childbearing potential must have a negative pregnancy test and agree to use an effective form of birth control.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harbor-UCLA Medical Center
Torrance, California, 90509
About this study
Psychiatric Research Study For Cancer Patients
The Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center is conducting a study designed to measure the effectiveness of the novel psychoactive medication psilocybin on the reduction of anxiety, depression, and physical pain.
Read the detailed description
The significance of this study is that it is addressing the important issues of psychological and spiritual well being of people who have advanced cancer. In 2001, the National Cancer Policy Board of the Institute of Medicine and National Research Council issued a report (Improving Palliative Care for Cancer: Summary and Recommendations) that specifically recommended research be conducted using novel agents and methods. Psilocybin is a novel agent which produces a profound alteration in your state of consciousness. It is the main active ingredient found in "magic mushrooms".
Our specific aim is to learn whether this psychoactive drug, psilocybin, might be effective in reducing anxiety, depression and physical pain, and therefore improving your quality of life. This pilot study will start with 12 people ages 18-70. For each participant there will be two overnight admissions to the hospital. In one session you will be given a placebo and in the other you will get the active medication, but no one will know which drug is administered when. This is called a double blind study. You will be asked to fill out questionnaires about how you feel, your pain levels and your moods. There will also be at least two psychotherapy meetings before the study sessions, so that you are fully aware of what to expect and to have all your questions answered.
We cannot take you in the study if you have central nervous system (CNS) cancers, kidney disease, diabetes, abnormal liver function tests, epilepsy, cardiovascular disease including untreated high blood pressure (BP greater than 140/90), and pregnancy. The psychiatric exclusions are: you or an immediate family member with a history of a major psychiatric disorder, a current substance abuse problem, or an anxiety or a mood disorder within 1 year prior to the onset of symptoms of your current illness.
We also cannot take you in the study if you are taking certain medications, such as: anti-seizure, insulin and oral hypoglycemics, and cardiovascular drugs (except anti-hypertensive medications). Some antidepressant (SSRIs) medications cannot be taken within the two weeks prior to the session (except for Prozac, which cannot be taken in the last 5 weeks prior to the session).
You will get a MRI of the brain prior to admission (if you haven't had one in the prior two months), at the study's expense, to be sure there is no CNS involvement. You can provide us, or the study will pay for, lab work from the prior 2 weeks (CBC, liver function and renal function). The history and physical, neurological exam, EKG, and a urine pregnancy test (if you are a woman with child-bearing potential), will be done on admission by the house staff doctors.
You will be allowed to take your own medications while in the hospital, and will be encouraged to bring to the hospital personal photos, small memorabilia, and some of your favorite music that can be played during the sessions.
- Conditions
- Anxiety
- Being tested
- Psilocybin (drug), Niacin, MRI
- Keywords
- Anxiety, Depression, Mood, Cancer, Quality of Life, Psychiatric, Psilocybin, Alternative, Los Angeles
- Medical subject headings
- Anxiety Disorders, Depression, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin (drug)Drug
Also called 4-phosphoryloxy-N,N-dimethyltryptamine
Capsule (.2 mg/kg).
NiacinOther
Also called nicotinamide, vitamin B3
Active Placebo
MRIDiagnostic test
MRI required for study inclusion for purpose of ruling out metasteses to brain
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin | Experimental | Single, 6-hour treatment with 0.2 mg/kg active psilocybin capsule. Receives: Drug: Psilocybin (drug); Diagnostic Test: MRI |
| Active Niacin Placebo | Active comparator | Each subject functioned as their own control, receiving niacin placebo capsule in a single 6-hour session. Receives: Other: Niacin; Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
State-Trait Anxiety Inventory for Adults - Form Y-2
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startApr 2004
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Within-subject cross-over study. Each participant received active drug and active placebo on separate dates.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Heffter Research Institute
- Responsible party
- Principal investigator, Charles S. Grob, M.D., Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Investigators
- Charles S. Grob, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302744
- Sponsor's protocol ID
- HEFFTER11287-01
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2006
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Grob CS, Danforth AL, Chopra GS, Hagerty M, McKay CR, Halberstadt AL, Greer GR. Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer. Arch Gen Psychiatry. 2011 Jan;68(1):71-8. doi: 10.1001/archgenpsychiatry.2010.116. Epub 2010 Sep 6.
PubMed 20819978
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Psilocybin in Advanced-Stage Cancer Patients With Anxiety
- ClinicalTrials.gov ID
- NCT00302744
- Acronym / sponsor ID
- HEFFTER11287-01
- Conditions
- Anxiety
- Keywords
- Anxiety, Depression, Mood, Cancer, Quality of Life, Psychiatric, Psilocybin, Alternative
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Collaborators
- Heffter Research Institute
- Study start
- Apr 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 14 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Psychiatric Research Study For Cancer Patients
The Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center is conducting a study designed to measure the effectiveness of the novel psychoactive medication psilocybin on the reduction of anxiety, depression, and physical pain.
Detailed description
The significance of this study is that it is addressing the important issues of psychological and spiritual well being of people who have advanced cancer. In 2001, the National Cancer Policy Board of the Institute of Medicine and National Research Council issued a report (Improving Palliative Care for Cancer: Summary and Recommendations) that specifically recommended research be conducted using novel agents and methods. Psilocybin is a novel agent which produces a profound alteration in your state of consciousness. It is the main active ingredient found in "magic mushrooms".
Our specific aim is to learn whether this psychoactive drug, psilocybin, might be effective in reducing anxiety, depression and physical pain, and therefore improving your quality of life. This pilot study will start with 12 people ages 18-70. For each participant there will be two overnight admissions to the hospital. In one session you will be given a placebo and in the other you will get the active medication, but no one will know which drug is administered when. This is called a double blind study. You will be asked to fill out questionnaires about how you feel, your pain levels and your moods. There will also be at least two psychotherapy meetings before the study sessions, so that you are fully aware of what to expect and to have all your questions answered.
We cannot take you in the study if you have central nervous system (CNS) cancers, kidney disease, diabetes, abnormal liver function tests, epilepsy, cardiovascular disease including untreated high blood pressure (BP greater than 140/90), and pregnancy. The psychiatric exclusions are: you or an immediate family member with a history of a major psychiatric disorder, a current substance abuse problem, or an anxiety or a mood disorder within 1 year prior to the onset of symptoms of your current illness.
We also cannot take you in the study if you are taking certain medications, such as: anti-seizure, insulin and oral hypoglycemics, and cardiovascular drugs (except anti-hypertensive medications). Some antidepressant (SSRIs) medications cannot be taken within the two weeks prior to the session (except for Prozac, which cannot be taken in the last 5 weeks prior to the session).
You will get a MRI of the brain prior to admission (if you haven't had one in the prior two months), at the study's expense, to be sure there is no CNS involvement. You can provide us, or the study will pay for, lab work from the prior 2 weeks (CBC, liver function and renal function). The history and physical, neurological exam, EKG, and a urine pregnancy test (if you are a woman with child-bearing potential), will be done on admission by the house staff doctors.
You will be allowed to take your own medications while in the hospital, and will be encouraged to bring to the hospital personal photos, small memorabilia, and some of your favorite music that can be played during the sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Within-subject cross-over study. Each participant received active drug and active placebo on separate dates.
| Arm | Type | Receives |
|---|---|---|
| Psilocybin | Experimental | Drug: Psilocybin (drug), Diagnostic Test: MRISingle, 6-hour treatment with 0.2 mg/kg active psilocybin capsule. |
| Active Niacin Placebo | Active comparator | Other: Niacin, Diagnostic Test: MRIEach subject functioned as their own control, receiving niacin placebo capsule in a single 6-hour session. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have advanced-stage cancer and anxiety.
- Be between the ages of 18 - 70.
- Note: The location for the two treatment sessions is Los Angeles, California. Treatment sessions are scheduled three to six weeks apart, and they include one overnight hospital stay both times.
Key exclusion criteria (9 listed)
- Not have cancer that affects the central nervous system or brain function.
- Have no history of major psychiatric disorder.
- Have no kidney disease, abnormal liver functions, epilepsy, or cardiovascular disease, including untreated hypertension.
- Not be taking insulin, oral hypoglycemic, anti-seizure, or cardiovascular medications (except anti-hypertensive drugs).
- May take PRN benzodiazepines up to 3 days before the session.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin (drug)Also: 4-phosphoryloxy-N,N-dimethyltryptamineCapsule (.2 mg/kg). | Drug | Psilocybin |
| NiacinAlso: nicotinamide, vitamin B3Active Placebo | Other | Active Niacin Placebo |
| MRIMRI required for study inclusion for purpose of ruling out metasteses to brain | Diagnostic test | Active Niacin Placebo, Psilocybin |
Primary outcome
Anxiety
Time frame: 6 months
State-Trait Anxiety Inventory for Adults - Form Y-2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Results publication: PubMed 20819978Grob CS, Danforth AL, Chopra GS, Hagerty M, McKay CR, Halberstadt AL, Greer GR. Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer. Arch Gen Psychiatry. 2011 Jan;68(1):71-8. doi: 10.1001/archgenpsychiatry.2010.116. Epub 2010 Sep 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles S. Grob, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Psilocybin (drug), Niacin and MRI in people with Anxiety, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00302744, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.