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New treatment option for Opioid Use Disorder
Official title Psilocybin for Opioid Use Disorder (OUD)
ClinicalTrials.gov ID: NCT06796062
What this study is testing
What is Psilocybin?
Psilocybin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for opioid use disorder.
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
- This is a double-blind, adaptive, 2-stage, multi-site, phase 2 randomized controlled clinical trial designed to evaluate effects of moderate and high dose psilocybin, relative to low-dose psilocybin control, in OUD patients who continue to use illicit opioids in spite of adherence to standard-of-care treatment with methadone. Up to 480 participations will be consented to yield 240 randomized participants.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 weeks
- Which group you join is decided by chance.
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 65
You may be able to join if
- Are able to provide voluntary informed consent.
- Have a breath alcohol concentration ≤ 0.01% at Screening Part 2, as determined by a breath alcohol reading from a calibrated breath alcohol sensor...
- Are able to read, speak, and understand English, as documented during the informed consent process. a. Non-English speaking people will be excluded...
- Are 18 to 65 years old, inclusive, at Screening Part 2.
- Have Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM 5) diagnosis of OUD, based on an evaluation performed by trained...
You likely can't join if
- Have any medical condition that would preclude safe participation in the study, including the following, as determined by medical history review...
- Seizure disorder
- Significantly impaired liver function, defined as 1) alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 5 × upper limit of...
- Cardiovascular disease including coronary artery disease, angina, history of arrhythmia (unless a successful ablation has been performed), heart...
- Uncontrolled hypertension with systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg. (Note: people who otherwise qualify at...
- Serious ECG abnormalities present on the ECG obtained on Day -65 (e.g., evidence of ischemia, myocardial infarction, QT interval corrected for heart...
See the full eligibility criteria
Who can join
- Are able to provide voluntary informed consent.
- Have a breath alcohol concentration ≤ 0.01% at Screening Part 2, as determined by a breath alcohol reading from a calibrated breath alcohol sensor. (Note: this criterion may be re-evaluated within the 30-day screening...
- Are able to read, speak, and understand English, as documented during the informed consent process. a. Non-English speaking people will be excluded because the study is using only validated English-language versions of...
- Are 18 to 65 years old, inclusive, at Screening Part 2.
- Have Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM 5) diagnosis of OUD, based on an evaluation performed by trained study staff using the Mini-International Neuropsychiatric Interview (MINI).
- Want to stop their use of illicit opioids.
- Are in treatment at one of participating Opioid Treatment Programs (OTPs) for at least 6 months at the time of Screening Part 2.
- Are currently prescribed a methadone dose of at least 60 mg per day.
- Methadone dosage has changed by no more than 20 mg in the past month
- Have taken methadone at least 25 out of the last 30 days
- Have had at least one urine drug screen positive for non-prescribed opioids in the past 30 days at the time of Screening Part 2
- Report using opioids by insufflation, injection, or smoking
- Are able and willing to adhere to all study requirements, including attending all study visits and treatment sessions, and completing all assessments.
- Are able to provide at least one drug screen negative for illicit opioids, cocaine, and amphetamine-type stimulants during the screening period. (Note: this criterion may be re-evaluated within the 30-day screening...
- Agree to refrain from any non-prescribed psychotropic substance or illicit drug use for at least 72 hours prior to IP administration, with the exceptions of alcohol, cannabis, nicotine, and caffeine. Regarding alcohol...
- Agree to refrain from taking all non-prescription medications and supplements (nutritional and herbal) for at least 1 week prior to the IP administration session unless approved by the Investigator.
- Are able to swallow capsules.
- Agree to practice effective contraception as described below.
- people are considered able to become pregnant unless they:
- Do not have a uterus
- Are postmenopausal (has had 12 months of natural amenorrhea with a matching clinical profile [age, history of vasomotor symptoms]) prior to Screening Part 2, or
- Are surgically sterile (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)
- people who are able to become pregnant must:
- Have a negative pregnancy test at Screening Part 2 (Reassessed at Day 0 (pre-IP administration);
- Not be currently breastfeeding;
- Not intend to become pregnant during participation in this study;
- Agree to use a highly effective form of contraception from the time of the Screening Part 2 until 7 days after the IP Administration Session. Highly effective forms of contraception include: 1) Consistent and correct...
- Agree not to donate or bank eggs from the time of Screening Part 2 until 7 days after the IP Administration Session.
- people who can emit sperm are defined as those who:
- Have one or more testes and
- Have not had a documented effective surgical sterilization procedure (e.g., vasectomy, radical prostatectomy).
- people who can emit sperm must:
- Practice effective contraception from Screening Part 2 until 7 days after the IP Administration Session. Effective means forms of contraception include:
- use condoms with spermicide if engaging in penile/vaginal intercourse;
- abstain from penile/vaginal intercourse, if the Investigator determines that the subject can reliably adhere to the plan, based on evaluation of the social circumstances of the subject
- Agree not to donate or bank sperm from the time of the Screening Part 2 until 7 days after the IP Administration Session
- Have a family member or friend who can assist with transportation and activities of daily living after the IP Administration Session, as determined by self-report at Screening Part 2 and confirmed by direct...
- Are able to provide adequate locator information. This criterion may be re-evaluated within the 30-day screening period.
What rules you out
- Have any medical condition that would preclude safe participation in the study, including the following, as determined by medical history review, physical examination, electrocardiogram (ECG), and clinical laboratory...
- Seizure disorder
- Significantly impaired liver function, defined as 1) alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 5 × upper limit of normal (ULN); 2) ALT or AST \> 3 × ULN with concomitant total bilirubin...
- Cardiovascular disease including coronary artery disease, angina, history of arrhythmia (unless a successful ablation has been performed), heart failure, history of heart valve replacement, and history of...
- Uncontrolled hypertension with systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg. (Note: people who otherwise qualify at Screening Part 2 will have 3 opportunities to produce 1 blood pressure...
- Serious ECG abnormalities present on the ECG obtained on Day -65 (e.g., evidence of ischemia, myocardial infarction, QT interval corrected for heart rate [QTc] prolongation (QTc \> 0.45 seconds), arrhythmia, or...
- Hyperthyroidism
- Insulin-dependent diabetes
- Any other medical condition which precludes safe participation in the study in the medical opinion of the Investigator. (Note: medical history will be updated and ECG will be repeated on Day 0, prior to dosing. Those...
- Have any of the following DSM-5 psychiatric disorders, as determined by the MINI, Psychiatric History and Psychosis Screening Questionnaire at Screening Part 2: (Note: psychiatric history will be re-evaluated on Day 0...
- Lifetime history of schizophrenia spectrum or other psychotic disorder.
- Lifetime history of bipolar disorder.
- Current severe major depression (based on a MINI diagnosis of major depression, current, and a MADRS score \>34 at Screening)
- Alcohol use disorder including alcohol withdrawal.
- More than mild opioid withdrawal (COWS score \>12). (This criterion may be re-evaluated within the 30-day screening period. This criterion will be reassessed on Day 0. Those not meeting the criterion may be rescheduled...
- Have active suicidal ideation with intent, based on Columbia - Suicide Severity Rating Scale (C-SSRS) assessment (severity score \>3) at Screening Part 2, confirmed by the Investigator. (Note: this criterion will be...
- Have made a suicide attempt within the past 12 months, based on C-SSRS assessment at Screening Part 2 and confirmation by the Investigator. (Note: this criterion will be reassessed at each visit that occurs prior to Day...
- Have a family history (first degree relatives) of schizophrenia, schizoaffective disorder, or bipolar disorder type 1.
- Have a history of hallucinogen use disorder or hallucinogen persisting perception disorder (HPPD).
- Have any hallucinogen use in the past 1 year.
- Have \> 25 lifetime uses of classic psychedelics.
- Are currently in jail, prison, or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities.
- Are taking any protocol-prohibited medications and supplements (See Section 6.5.3). Any prohibited medications and supplements must have been stopped for at least 5 elimination half-lives or 14 days, whichever is...
- Have a known allergy or hypersensitivity to psilocybin or any of the materials contained in the IP used in the study.
- Have an allergy, hypersensitivity, or other contraindication that would preclude safe treatment of acute hypertension, anxiety, or psychotic symptoms if necessary during or immediately after the IP Administration...
- Have any other medical, psychiatric, or psychosocial disorder, symptom, condition, or situation that is likely to interfere with the establishment of rapport, adherence to study requirements, or safe administration of...
The study team makes the final eligibility decision.
Where it's taking place
- Albuquerque, New Mexico, United States
- Brooklyn, New York, United States
- New York, New York, United States
- The Bronx, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Albuquerque, New Mexico, United States; Brooklyn, New York, United States; New York, New York, United States; The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.