UCSF Seeks Participants for Four Psilocybin Clinical Trials

The University of California San Francisco (UCSF) is seeking participants for four clinical trials exploring the effects of psilocybin on mental health conditions and chronic low back pain.

The university is currently conducted eight clinical trial related to psilocybin, with two “in progress, not accepting new patients”, two that are “not yet accepting patients”, and four that are currently “open to eligible people”.

Below is a summary of the four trials that are currently seeking participants, with links for those interested in contacting the university to apply or to seek further information.

Study of Psilocybin for Anorexia in Young Adults

Summary

This is a single site trial of psilocybin therapy for the treatment of refractory Anorexia Nervosa in young adults. The psilocybin therapy will include three preparatory sessions, psilocybin dosing session one (20mg), two integration sessions, psilocybin dosing session two (30mg), and four final integration sessions. Eating disorder symptoms will be measured pre and post treatment. Two family members of each young adult participant will be enrolled in the study. One of which will be required to attend a portion of two preparatory sessions and a portion of two integration sessions and receive psychoeducation about supporting the young adult participant through preparation and integration for psilocybin therapy. Investigators hypothesize that psilocybin will increase cognitive flexibility and that this increase will predict long-term changes in cognitive rigidity, habitual eating, and exercise behaviors in patients with Anorexia Nervosa.

Open to people ages 18-25. You can join if:

  • Able to understand and provide informed consent.
  • Between 18 and 25 years old at time of screening.
  • Meets Diagnostic and Statistical Manual (DSM-5) criteria for any type of Anorexia Nervosa
  • Currently experiencing symptoms of Anorexia Nervosa
  • Persistence of Anorexia Nervosa diagnosis after at least one attempt of eating disorder focused treatment or higher level of care
  • Comfortable reading and writing in English
  • Have no anticipated changes in medication or surgical procedures for trial duration
  • Commit to attend all in-person and remote study visits and participate in all data collection procedures
  • Able to identify two family members or close friends to co-enroll in the study, who will be required to participate in select therapy sessions, pick them up and stay with them overnight on dosing days.
  • Agree to use a highly effective form of contraception for two weeks prior to starting the study and one month after finishing the study.
  • Agree that for one week preceding each psilocybin session, they will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the research team. Exceptions will be evaluated by the research team and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.
  • Agree to consume approximately the same amount of caffeine-containing beverages (e.g., coffee, tea) that they usually consume before arriving at the research unit on the mornings of psilocybin administration sessions. If the young adult participant does not routinely consume caffeinated beverages, they must agree not to do so prior to psilocybin administration sessions.

To contact the university about this trial, click here.

Psilocybin Therapy for Depression in Parkinson’s Disease

Summary

The purpose of this study is to understand whether people with Parkinson’s Disease and depression have improvement in their symptoms after psilocybin therapy.

This is a randomized controlled trial of oral psilocybin therapy for depression in people with Parkinson’s disease (PD). The primary goal is to examine efficacy of psilocybin therapy in this patient population. We will enroll 60 people ages 40 to 80 with clinically diagnosed early to moderate stage Parkinson’s disease (Hoehn and Yahr Stage 1-3 during an “on” period), who meet criteria for moderate or greater depression severity and meet all other inclusion and exclusion criteria at screening. Participants will complete two drug administration sessions where they will each receive a dose of oral psilocybin ranging from low (“microdose”) to high in a medically monitored setting with psychotherapeutic support. Participants will also complete a series of psychotherapy sessions before and after each drug administration session. Clinical assessments, neuroimaging, non-invasive brain stimulation, and peripheral blood draws will be used to quantify changes in depression, other non-motor and motor symptoms of PD, quality of life, and selected neural and blood-based biomarkers at multiple time points. Follow-up will continue to 3 months after the second session. Primary endpoints will evaluate efficacy, safety, and tolerability of study procedures.

Open to people ages 40-80. You can join if:

  • Age 40 to 80
  • Comfortable speaking and writing in English
  • Have neurologist-diagnosed idiopathic Parkinson’s disease (PD), Hoehn and Yahr stages 1 to 3 during an “on” phase (time when medication/DBS for parkinsonian motor feature, including bradykinesia and rigidity is in effect)
  • Currently experiencing depressive symptoms
  • Able to attend all in-person visits at UCSF as well as virtual visits
  • Have a primary care provider, neurologist, or psychiatrist who is actively managing or coordinating

To contact the university about this trial, click here.

Psilocybin Therapy for Chronic Low Back Pain

Summary

This study evaluates whether psilocybin therapy helps patients cope with chronic low back pain more effectively. Patients may be recruited at Stanford and University of California San Francisco (UCSF), study procedures will occur at UCSF. Each participant will receive a dose of psilocybin with possibly one or more other drugs. Participants will undergo two preparation sessions, a dosing session, three integration sessions to discuss their psilocybin experience, and several follow up sessions.

Chronic pain is associated with higher levels of pain-related distress, depression, emotional dysfunction, helplessness, hopelessness, and suicidality. Psilocybin is a psychoactive drug that may be well-suited to easing the psychological and emotional symptoms of distress associated with chronic pain. Previous studies testing psilocybin therapy have shown improvements on multiple behavioral and psychiatric outcomes, but it is unknown whether psilocybin therapy similarly enables patients to cope with chronic pain more effectively. The investigators will determine whether psilocybin therapy improves patients’ ability to cope with chronic low back pain. If psilocybin therapy is an effective treatment in this population, its use could be incorporated into interventions for chronic low back pain and other psychological conditions.

Open to people ages 25-70. You can join if:

  • Age 25 to 70 years old
  • Comfortable speaking and writing in English
  • Diagnosed with chronic low back pain
  • Able to attend all in-person visits at UCSF as well as virtual visits
  • Has tried at least two previous medications/ procedures and physical therapy trials for low back pain

To contact the university about this trial, click here.

Neural and Physiological Correlates of Psychedelic Sub-states

Summary

The main purpose of this study is to gain a better understanding of the distinct mental states and physical reactions that can arise during a psychedelic experience. By repeatedly assessing the same participants in an MRI while under the effects of psilocybin, the investigators want to identify reliable brain and body reactions arising during these psychedelic experiences. It is hoped that this will provide an insight to inspire future research on psilocybin and related psychedelics as well as inform on their therapeutic action. This study will involve up to 12 healthy volunteers with previous psychedelic experience. Participants in this study will be given four doses of psilocybin, with breaks of at least seven days in between dosing visits. The first dosing visit will feature a 10 mg dose of psilocybin, which can be considerate a low to moderate dose, whereas the remaining three dosing visits will feature 25 mg psilocybin, a high dose that is consistent with the dosage chosen for several modern clinical trials with psilocybin. From the initial in-person screening visit to the final follow-up, participants will be in this study for approximately 6-12 weeks and visit the research site 5 times. The first visit will be an in-person screening visit, during which the investigators will assess participants’ eligibility to be enrolled. There will be 4 subsequent visits to the scan center for dosing and magnetic resonance imaging (MRI) scanning, and there will be a final remote follow up. Each of the four dosing visits will include four periods of lying within the MRI scanner for scanning, each of these ‘in-scanner’ sessions will last for ~ 45 minutes. Actual scans, which are also called ‘runs’ last for ~ 12 mins. During these ‘runs’, the investigators will ask participants two brief questions about how positive or negative their current experience is every 100 seconds. They will be able to record their answers using a button box which they will be operating with their hand. One day after each dosing visit, the investigators will schedule a phone call with the participant to check how they are doing and perform an informal interview focused on their experience while under the effects of psilocybin.

For people ages 21-70. You can join if:

Inclusion Criteria:

  • Have had previous experiences with psychedelic substances
  • Mentally and physically healthy
  • Have had prior experiences with MRI machines (optional but preferred)
  • Flexible schedule- able to commit to scans once or twice per week for 4 weeks in a row
  • Are between 21 and 70 years of age
  • Are fluent in speaking and reading English
  • Can swallow pills/capsules
  • If able to become pregnant, must be non-lactating, have a negative pregnancy test at study entry and prior to each Experimental Session and must agree to an adequate form of birth control and contraception over the course of the study. Adequate forms of birth control or contraception include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner, or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom). Not of childbearing potential is defined as documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, and/or tubal ligation), permanently sterile by medical device such as Essure, postmenopausal, or male by birth. Contraception applies to males as well as females and male participants must not be planning sperm donation within the study period.
  • Able and willing to provide informed consent
  • Able and willing to use computers and tablets or phones to enter electronic data
  • Agree to inform the investigators within 48 hours of any new or changed medical conditions.

To contact the university about this trial, click here.

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