Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT06608459
Brief Summary:
The goal of this clinical trial is to learn if it is feasible to use PEX010 for the treatment of opioid use disorder in adults. The study will also assess the safety of PEX010. The main questions it aims to answer are:
Can we successfully recruit participants, provide the drug and retain participants for the duration of the study?
What medical problems do participants experience when taking PEX010?
Participants will:
Take PEX010 twice during the study Engage in cognitive behavioural therapy Visit the clinic once or twice per week for study intervention and followup visits
Detailed Description:
In this open-label study participants will receive PEX010, standardized to contain 25mg or 35 mg psilocybin, in conjunction with therapy. An open-label design was chosen given the novelty of this approach in treating OUD and high risk associated with opioid use.
Following screening and baseline visits, participants will receive 3 preparation sessions with psychotherapy, 2 PEX010 sessions, 2 integration sessions with psychotherapy, and 3 follow-up visits.
Study:
NCT06608459
Study Brief:
Protocol Section:
NCT06608459