Every prospective participant undergoes a thorough and multi-step evaluation process before enrolling in a clinical trial.

The process begins with an introductory conversation with a member of our clinical evaluation team. The purpose of the call is to determine whether a current or future study may be appropriate. During the call, we prioritize answering questions and communicating our offerings and enrollment process transparently. We review medical and psychiatric history, treatment history, and ask about any contraindications to identify safety risks early on.

The process begins with an introductory conversation with a member of our clinical evaluation team. The purpose of the call is to determine whether a current or future study may be appropriate. During the call, we prioritize answering questions and communicating our offerings and enrollment process transparently. We review medical and psychiatric history, treatment history, and ask about any contraindications to identify safety risks early on. 

If appropriate, prospective participants visit our clinic for a comprehensive screening that may include, but is not limited to:

• Medical and psychiatric history
• Current medications
• Treatment history
• Family history
• Physical examination and vital signs
• Laboratory testing
• Diagnostic assessments and symptom questionnaires
• Review of relevant medical records

Our multidisciplinary team reviews the information to evaluate study eligibility by determining whether enrollment is safe and suitable for the prospective participant.

Clinical monitoring continues throughout the entirety of participation in each of our trials with check-ins at every interaction with our staff.

Dosing visits occur in safe, private, and intentionally designed treatment rooms in the presence of at least one clinical team member at all times. Our therapists and medical professionals assess physical and psychological safety before, during, and after the dosing experience. Vital signs are monitored at protocol-defined intervals, clinical events are documented, and participants are discharged only after the physician ensures they are ready to leave safely with an identified support person.

Safety assessments continue throughout follow-up visits for the duration of the study.

We view informed consent as an ongoing and iterative process.

Before screening, participants receive the study’s informed consent materials in advance so they have time to review and prepare questions.

During the screening visit, a member of the clinical team carefully reviews every element of the Informed Consent Form, including, but is not limited to:

• Study purpose and background
• Expectations of assessments and procedures
• Potential risks and benefits
• Participant rights and responsibilities
• Privacy and confidentiality of personal information 

Participants are encouraged to ask questions and raise concerns even after the document is signed and study staff continuously remind participants they may withdraw from the study at any time.

The unique nature of psychedelic clinical trials requires iterative consent discussions, a practice that reflects Sunstone’s commitment to empower participants and ensure their comfort and safety. For example, during preparation sessions, therapists collaborate with participants to discuss preferences and boundaries. A critical aspect of this conversation is determining the role of therapeutic physical touch, if any. These discussions create clear expectations which strengthens the therapeutic alliance and fosters a safe environment.

Consent is revisited throughout participation, even after dosing. At every study visit, our clinical team verifies understanding, comfort, and willingness before performing study procedures or providing therapeutic support.

At Sunstone, the dosing session is one part of the therapeutic process. Prior to every dosing experience, preparation sessions help participants understand the treatment process and establish therapeutic rapport with their therapist. Participants are encouraged to share their background and set intentions. 

Following each dosing, therapists meet with participants for integration sessions. Here, therapists facilitate conversations to help participants process their experience, explore emerging insights and meaning, and translate them into daily life. Sunstone goes beyond traditional integration protocols by offering additional sessions for participants who request or require extra support. 

Community is a core principle at Sunstone. We design clinical trials that incorporate group-based therapy among participants with shared experiences. To help build a strong support network, participants can access study-specific group integration for up to a year. We also offer resources to the individuals in our participants’ lives to promote an informed and supportive environment outside our clinic.

Beyond our clinical trials, we offer monthly virtual meetings for Sunstone alumni. These integration circles serve as a supportive space for past participants to engage in a community dedicated to continuous connection. 

Sunstone also offers traditional talk therapy. Our providers are our research therapists who deliver their care through precise expertise and trauma-informed approaches. This is available to both alumni and new patients.