Open-label Study to Assess the Safety and Efficacy of TRP-8802 With Psychotherapy in Adult Participants With Fibromyalgia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05128162|
Recruitment Status : Not yet recruiting
First Posted : November 19, 2021
Last Update Posted : November 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Drug: TRP-8802 Behavioral: Psychotherapy||Phase 2|
Fibromyalgia is a chronic syndrome of widespread musculoskeletal pain that often manifests with a cluster of co-occurring symptoms, including sleep disturbances, fatigue, cognitive dysfunction, and mood problems including anxiety and depression. Recent studies have provided evidence of altered central pain pathways. Current management of FM typically takes a multidimensional approach including behavioral therapy, exercise, and medication. However, current medications provide only modest benefit and carry significant side effect burden, leading many people with FM to seek other alternatives.
Psilocybin therapy (psilocybin delivered in concert with psychotherapy) may be a potentially safe and effective treatment for symptoms associated with FM. Indeed, psilocybin therapy has shown positive effects in treating cancer-related psychiatric distress, depression and anxiety, treatment-resistant depression, and nicotine or alcohol addiction. The United States Food and Drug Administration (FDA) has granted a Breakthrough Therapy designation for psilocybin in treatment-resistant depression and major depressive disorder. Psilocybin therapy is generally safe and well-tolerated when conducted under controlled conditions. While no clinical studies have explored psychedelic effects among people with FM, a recent review outlined potential mechanisms through which psychedelics could alleviate chronic pain symptoms.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2a, Open-label, Pilot Study to Assess the Safety and Efficacy of Psilocybin (TRP-8802) Administration in Concert With Psychotherapy Among Adult Patients With Fibromyalgia|
|Estimated Study Start Date :||March 2022|
|Estimated Primary Completion Date :||November 2023|
|Estimated Study Completion Date :||May 2024|
Experimental: Open Label Oral Psilocybin
This is an open-label study, and participants who meet the inclusion and exclusion criteria will be eligible and invited to enroll. Enrolled participants are planned to receive 2 doses of TRP-8802: a 15 mg dose followed 2 weeks later by a 25 mg dose. The total planned duration of the study for an individual participant from screening to last follow-up is approximately 8 months.
Two oral doses of TRP-8802 in a capsule formulation taken approximately 2 weeks apart.
Other Name: Psilocybin
1. Pre-dose preparatory sessions; 2. Dosing day monitoring; and, 3. Post-dose integration sessions.
- To assess the safety of TRP-8802 under the conditions of this trial measuring vital signs [ Time Frame: 4 weeks following the second dose ]Measuring Heart Rate (HR) beats per minute (BPM)
- To assess the safety of TRP-8802 under the conditions of this trial measuring vital signs [ Time Frame: 4 weeks following the second dose ]Measuring Blood Pressure (BP) millimeters of mercury (mm Hg)
- To assess the safety of TRP-8802 under the conditions of this trial measuring Adverse Events [ Time Frame: 4 weeks following the second dose ]Adverse Events (AE) Incidence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05128162
|Contact: Jim Gilligan, PhDfirstname.lastname@example.org|
|United States, Michigan|
|University of Michigan - Functional MRI laboratory|
|Ann Arbor, Michigan, United States, 48105|
|Contact: Kevin F Boehnke, PhD|