To better understand the potential benefits of psychedelics in overeating disorders, Tryp Therapeutics will conduct a safety and feasibility clinical trial using TRP 8802 among individuals with Binge Eating Disorder. This is a single-center phase 2a open-label study to assess the safety and feasibility of a single dose of TRP 8802 in subjects with BED. Subjects will undergo screening, preparation therapy sessions, dosing, integration therapy sessions, and follow-up for 12 weeks following the dose of TRP 8802. The total participation in the study will be up to approximately 5 months.
Binge eating disorder is the most common eating disorder and is associated with obesity and psychiatric comorbidities, including depression, and impulsive and compulsive disorders. Binge eating disorder is marked by severe disturbance to a person's control over their eating behaviors and high anxiety around food. Various programs using psilocybin paired with psychotherapy have shown positive effects in treating a variety of psychiatric and behavioral conditions, including cancer-related psychiatric distress, anxiety, treatment-resistant depression, and nicotine and alcohol addiction. Based on clinical precedents, relevant neuropharmacology, and mechanistic similarities, psilocybin is theorized to have the potential to be part of the treatment of overeating disorders. TRP-8802 could accomplish this by moderating overall anxiety, anxiety around food, perseveration, and repetitive and intrusive thoughts about food in people with BED. The primary objective of this study is to: 1\. Assess the safety of a single dose of TRP 8802 in participants with binge eating disorder (BED) during the TRP 8802 dosing session, and through 12 weeks following dosing (i.e., Week 14).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
A single (1) 25 mg oral dose of TRP 8802 will be administered in a carefully monitored setting following 6 to 8 hours of preparatory psychotherapy. Subjects will be in the study for 12 weeks following the dose of TRP 8802 (until Week 14), approximately 5 months from initiation of screening through the last follow-up.
A single (1) 25 mg oral dose of TRP 8802 will be administered in a carefully monitored setting following 6 to 8 hours of preparatory psychotherapy. Subjects will be in the study for 12 weeks following the dose of TRP 8802 (until Week 14), approximately 5 months from initiation of screening through the last follow-up.
University of Florida
Gainesville, Florida, United States
Assess the safety of a single dose of TRP 8802 in participants with BED during the TRP 8802 dosing session, and through 12 weeks following dosing
Safety assessments will be conducted to monitor AEs, including SAEs, protocol specific safety laboratory assessments, protocol specific vital signs and other tests/questionnaires that are deemed crucial to the safety evaluation of the study. Planned timing for all safety assessments is provided in the SOA.
Time frame: 12 weeks following dosing
Evaluate the feasibility of inducing the psychedelic state with TRP 8802 in a BED population.
Magnitude and duration of TRP 8802-induced dissociative effects in participants with BED using the MEQ30 and MRS
Time frame: 12 weeks following dosing
Determine the preliminary clinical activity and the effects of TRP 8802 in conjunction with psychotherapy on the frequency of binge eating episodes in a BED population through 4 weeks following dosing (i.e., Week 6)
Frequency of binge eating episodes as measured by a modified Eating Questionnaire
Time frame: 6 Weeks
Determine the preliminary clinical activity and the effects of TRP 8802 in conjunction with psychotherapy on weight-related indicators in a BED population through 4 weeks following dosing (i.e., Week 6)
Waist Circumference and BMI
Time frame: 6 Weeks
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