Opioid Use Disorder study: Psilocybin
Official title Psilocybin on Brain Mechanisms of Motivation in OUD
ClinicalTrials.gov ID: NCT06810310
What this study is testing
What is PEX010 (psilocybin)?
An investigational oral psilocybin drug being studied as a potential treatment for opioid use disorder. It is designed to act as a serotonin 5‑HT2A receptor agonist, which may modulate brain circuits involved in motivation, reward, and cognitive flexibility.
Also referred to as psilocybin, magic mushrooms.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how psilocybin changes brain activity related to motivation, reward, and self‑control, and how these changes might influence drug relapse and thinking flexibility.
- Who it's for
- Adults aged 18 to 60 with opioid use disorder living in the greater Philadelphia area.
- What's involved
- Participants will attend about seven visits that include medical screening, interviews, blood tests, brain scans (fMRI), therapy sessions before and after the psilocybin dose, and cognitive tests.
- Time commitment
- The study lasts about 7 visits over several weeks, with each visit lasting a few hours at the research office in Philadelphia.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- An informed consent document voluntarily signed and dated by the subject.
- Either 1) have a confirmed prescription for BUP-NX in a drug monitoring program database, have been on a stable dose of BUP-NX for at least one week...
- Physically healthy males and females, aged 18-60 years old, who meet criteria for opioid use disorder (based on DSM-5 criteria) as their primary...
- Females must be non-pregnant and non-lactating. Additionally, for females with childbearing potential (i.e., have not undergone sterilization via...
- Subject must read at or above eighth grade level and speak, understand, and write in English.
You likely can't join if
- Participation in clinical trial and receipt of investigational drug(s) during 30 days prior to the research study, except as explicitly approved by...
- Currently meets DSM-5 criteria for moderate to severe substance use disorder for any substance other than cocaine, alcohol, marijuana or nicotine as...
- Meets current or lifetime DSM-5 criteria for schizophrenia or any psychotic disorder, or organic mental disorder or has a first-degree family history...
- Meets current DSM-5 criteria for bipolar disorder --Meets current DSM-5 criteria for severe Major Depressive Disorder (mild and moderate MDD as well...
- Current or past significant trauma exposure with elevated Post-Traumatic Stress symptoms at the discretion of the PI.
- Presence of any another psychiatric disorder that in the opinion of the PI will interfere with completion of the study or place the patient at...
See the full eligibility criteria
- An informed consent document voluntarily signed and dated by the subject.
- Either 1) have a confirmed prescription for BUP-NX in a drug monitoring program database, have been on a stable dose of BUP-NX for at least one week, and plan to continue taking BUP-NX for at least 12 weeks or 2) have...
- Physically healthy males and females, aged 18-60 years old, who meet criteria for opioid use disorder (based on DSM-5 criteria) as their primary diagnosis and are voluntarily seeking treatment.
- Females must be non-pregnant and non-lactating. Additionally, for females with childbearing potential (i.e., have not undergone sterilization via hysterectomy, bilateral tubal ligation, or bilateral oophorectomy, or at...
- Subject must read at or above eighth grade level and speak, understand, and write in English.
- IQ score of greater than or equal to 80.
- Participation in clinical trial and receipt of investigational drug(s) during 30 days prior to the research study, except as explicitly approved by the Principal Investigator.
- Currently meets DSM-5 criteria for moderate to severe substance use disorder for any substance other than cocaine, alcohol, marijuana or nicotine as determined by the semi-structured interview.
- Meets current or lifetime DSM-5 criteria for schizophrenia or any psychotic disorder, or organic mental disorder or has a first-degree family history of these disorders, this includes a history of...
- Meets current DSM-5 criteria for bipolar disorder --Meets current DSM-5 criteria for severe Major Depressive Disorder (mild and moderate MDD as well as in stable remission are allowed if no suicidal risk and no ongoing...
- Current or past significant trauma exposure with elevated Post-Traumatic Stress symptoms at the discretion of the PI.
- Presence of any another psychiatric disorder that in the opinion of the PI will interfere with completion of the study or place the patient at heightened risk through participation in the study.
- Current or past month active suicidal ideations or lifetime history of serious suicidal attempt.
- Has evidence of significant hepatocellular injury as evidenced by elevated bilirubin levels (greater than 1.3), or, pulmonary (e.g., COPD), endocrine, cardiovascular, renal (creatinine clearance less than or equal to...
- History of serious head trauma or injury causing loss of consciousness that lasted more than 3 minutes and/or associated with skull fracture or intracranial bleeding or abnormal MRI.
- Seizure disorder or history of seizures not related to drug or alcohol withdrawal (excluding childhood febrile seizure).
- Presence of magnetically active prosthetics, plates, pins, broken needles, permanent retainer, bullets, etc. in patient's body (unless a radiologist confirms that its presence is unproblematic).
- Claustrophobia or other medical condition that disables the participant from lying in the MRI for approximately 60 minutes.
- Non-removable skin patches, at discretion of PI.
- Has received medication that could interact adversely with psilocybin within the time of administration of study agent based on the Medical Director's guidance.
- Needs treatment with any psychoactive (e.g., anti-depressants) medications (with the exception of Benadryl used sparingly, if necessary, for sleep).
- coronary artery disease, congenital long QT syndrome (prior diagnosis), cardiac hypertrophy, cardiac ischemia, congestive heart failure, myocardial infarction (prior diagnosis);
- tachycardia (defined as heart rate greater than 100 beats per minute);
- a clinically significant Screening ECG abnormality (e.g., atrial fibrillation); Note: A QTcF interval greater than 450 milliseconds is considered a clinically significant ECG abnormality
- artificial heart valve;
- any other significant current or history of cardiovascular condition, based on the clinical judgment of Medical Director, that would make a participant unsuitable for the study.
- Screening blood pressure SBP greater than135 mmHg or DBP greater than 85 mmHg on three separate readings; or
- Baseline blood pressure SBP greater than140 mmHg or DBP greater than 90 mmHg on three separate readings
The study team makes the final eligibility decision.
Where it is enrolling
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.