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High-dose psilocybin + buprenorphine for Opioid Use Disorder (BIPOD-Out Trial)
BIPOD-Out Trial Summary
This trial will look at the impact of a high dose (30 mg) and a very low dose (1 mg) of psilocybin therapy in addition to standard buprenorphine treatment
BIPOD-Out Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBIPOD-Out Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 trial • 95 Patients • NCT02061293BIPOD-Out Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
Are there any vacancies available for patients to participate in this trial?
"Information available on clinicaltrials.gov shows that patient enrollment is ongoing for this trial. The study was first listed on 2/8/2024 and most recently revised on 2/19/2024."
What is the upper limit of participants allowed to take part in this medical study?
"Indeed, information available on clinicaltrials.gov shows that this medical research investigation is actively seeking eligible individuals. The trial was initially published on February 8th, 2024 and most recently revised on February 19th, 2024. Enrollment of approximately 90 participants will take place at a single designated site."
May individuals younger than 20 years old participate in this research study?
"To be eligible for inclusion in this study, candidates must be at least 21 years old but no older than 70."
Is it possible for me to participate in this clinical trial?
"This clinical study is currently accepting 90 individuals aged between 21 and 70 who are grappling with opioid use disorder. Essential prerequisites include being proficient in English language skills, readiness to undergo or having already completed buprenorphine induction within the past three weeks, deemed low risk for suicidal tendencies by clinicians on the research team, providing written consent, meeting DSM-5 criteria for OUD diagnosis, abstaining from antidepressants for around five half-lives before enrollment, a history of prior buprenorphine maintenance therapy, testing positive for opioids through urine toxicology screening and ensuring access to secure housing arrangements."
Has the combination of high-dose psilocybin and buprenorphine received official approval from the FDA?
"Our research team at Power has evaluated the safety of High-dose psilocybin + buprenorphine to be a 2 on our scale. This rating is based on the fact that this trial is in Phase 2, indicating some existing safety data but no evidence yet supporting efficacy."
What are the specific objectives of this research study?
"The primary aim of this clinical investigation, which will span about 8 weeks, is to assess treatment adherence. Secondary aims involve monitoring the number of participants refraining from other substances apart from those being studied through a combination of TLFB and urine toxicology results; gauging anxiety levels using the State-Trait Anxiety Inventory (STAI), where higher scores indicate more severe mental states like apprehension and worry; and evaluating quality of life with the World Health Organization Quality of Life Brief Version (WHOQOL-BREF) questionnaire, which covers six domains and 24 subdomains reflecting various aspects affecting quality of life on a scale ranging from "
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