A guide for providers referring their patients to Sunstone Therapies for psychedelic-assisted therapy.
For many patients, participation in a clinical trial offers access to psychedelic-assisted therapy while contributing to the advancement of mental health research.
Providers can expand access by identifying potential candidates in their practice who might benefit from this investigational treatment as part of a broader, long-term treatment plan. Providers can protect patients and optimize outcomes by developing realistic expectations about the clinical trial process.
Here we provide a quick-reference framework for identifying prospective trial participants within a practice.
Indications we work with
What mental health conditions are being studied in psychedelic-assisted therapy trials?
Sunstone conducts clinical trials on investigational compounds for complex mood, trauma, and related conditions. As the field evolves, our psychedelic studies align with patient needs. We offer studies focusing on individuals with treatment-resistant depression, anxiety, and PTSD who haven’t found relief through traditional therapies.
The following indications are currently under study at our clinic:
- Major Depressive Disorder (MDD)
- Treatment-Resistant Depression (TRD)
- Post-Traumatic Stress Disorder (PTSD)
- Generalized Anxiety Disorder (GAD)
- Serious / Advanced Illness-Related Distress
- Examples: Adjustment disorder, demoralization, existential distress, and end-of-life anxiety associated with cancer or other life-threatening illnesses.
See below the current compounds we study:
- Methylone
- Psilocybin and analogues
- MDMA
- 5-MeO-DMT
Common contraindications + risks
What should providers review before referring?
Participant safety is of utmost importance. We adhere to rigorous guidelines and screening procedures to ensure the physical and psychological safety of each individual.
Study criteria evolve with the field, and requirements vary by study. Below is a guide to understand the current standard of contraindications for investigational psychedelic-assisted therapy in clinical trials. Trials may have criteria that are not listed below. Likewise, some studies may not exclude certain indications.
| Category | Contraindication |
| Psychiatric history/comorbidity | Schizophrenia, schizoaffective disorder, forms of psychotic disorder, major depressive disorder with psychotic features, bipolar type I, personality disorders, significant suicide risk |
| First degree family history | Schizophrenia, schizoaffective disorder, bipolar type I |
| Medical history | Recent stroke, myocardial infarction, clinically significant arrhythmia, uncontrolled hypertension, significant hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, neurological disease, seizure disorder, organic brain disorders, liver disease, uncontrolled hyper/hypothyroidism, uncontrolled diabetes |
| Concomitant medications or treatment history | Monoamine oxidase inhibitors, tricyclic antidepressants, supplements such as 5-HTP or St. John’s Wort, potential restrictions on stimulant use (for ADHD), recent changes to psychotherapy/inability to sustain consistency during trial, restrictions of time since last ketamine treatment, ECT, and TMS, restrictions on recreational drug use and previous psychedelics use |
Psychedelic-assisted therapy as a tool and not a cure
Framing expectations about the clinical trial experience
Participation in a clinical trial differs from traditional, standard-of-care treatment. As a referring provider, setting realistic expectations is critical because the patient’s mindset can shape their experience. For example, it is important to prepare patients for the possibility of dissatisfaction or disappointment that may occur due to: Being disqualified due to eligibility criteria, having a low intensity experience, or not obtaining their desired treatment outcome. There may be a worsening of symptoms or the development of other symptoms.
Psychedelic-assisted therapy is not a singular healing event, nor does it promise to live up to a patient’s hopes. Rather, it can be a step in the ongoing and long-term journey of wellbeing and self-discovery. Psychedelic-assisted therapy is an emerging and investigational tool in the evolving toolbox of mental healthcare options.
If you are a provider who has identified a prospective candidate in your practice who you would like to refer to us, please click here. For questions, please contact us at: info@sunstonetherapies.com.
Sources:
- Psychedelic Drug Development Tracker
- Psychedelic Therapy for PTSD, Depression & Trauma at Sunstone
- Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD (SUN004)
- NCT06564818 | “A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder” | ClinicalTrials.gov
- The Paradox of Expectations in Psychedelic Clinical Research | Psychology Today
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