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New treatment option for Opioid Use Disorder
Official title Exploration of Synaptotrophic Effects of Psilocybin in Opioid Use Disorder (OUD)
ClinicalTrials.gov ID: NCT06160284
What this study is testing
What is Psilocybin?
Psilocybin is an investigational medicine, given as an once-weekly, 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 study will examine the synaptotrophic effects of psilocybin among medically healthy, detoxified OUD subjects. Eligible OUD participants will undergo pre- and post- psilocybin administration PET scans with the [11C]-UCB-J radiotracer while inpatient.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 55
You may be able to join if
- Age between 25 and 55 years
- BMI between 19 and 35 kg/m2
- Voluntary, written, informed consent
- Physically healthy by medical history, physical, neurological, ECG, and laboratory examinations
- DSM-5 criteria for Opioid Use Disorder
You likely can't join if
- DSM-5 criteria for other substance use disorders (e.g., alcohol, cocaine, sedative hypnotics), except for nicotine (concurrent alcohol or drug use is...
- A primary DSM-5 Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression, as determined by psychiatric...
- Immediate (first-degree relative) family history of formally diagnosed schizophrenia or other psychotic disorders (e.g., delusional disorder...
- Individuals with a history or evidence of psychosis, including substance and nonsubstance related, as evaluated in assessments (MINI and Brief...
- History of Hallucinogen Use Disorder or Hallucinogen Persisting Perceptive Disorder
- A history of significant and/or uncontrolled medical or neurological illness
See the full eligibility criteria
- Age between 25 and 55 years
- BMI between 19 and 35 kg/m2
- Voluntary, written, informed consent
- Physically healthy by medical history, physical, neurological, ECG, and laboratory examinations
- DSM-5 criteria for Opioid Use Disorder
- Documented evidence (by urine toxicology) of opioid use (upon screening)
- Inpatient verified \> 1 week of abstinence from illicit opioids
- For females, a negative serum pregnancy (beta-HCG) test
- Participants are required to commit to employing dual contraceptive methods throughout the study and to abstain from sperm or egg donation during the study period and for 28 days following the final drug dose for ova...
- DSM-5 criteria for other substance use disorders (e.g., alcohol, cocaine, sedative hypnotics), except for nicotine (concurrent alcohol or drug use is allowed if it does not meet criteria for a substance use disorder and...
- A primary DSM-5 Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression, as determined by psychiatric history (Mini International Neuropsychiatric Interview, MINI) (Sheehan et...
- Immediate (first-degree relative) family history of formally diagnosed schizophrenia or other psychotic disorders (e.g., delusional disorder, schizoaffective disorder), or bipolar I/II disorder
- Individuals with a history or evidence of psychosis, including substance and nonsubstance related, as evaluated in assessments (MINI and Brief Psychiatric Rating Scale [BPRS]) before psilocybin administration
- History of Hallucinogen Use Disorder or Hallucinogen Persisting Perceptive Disorder
- A history of significant and/or uncontrolled medical or neurological illness
- Hypertension at screening defined as: systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg
- Heart rate outside the range of 60 to 100 beats per minute
- History of cardiovascular disease, including but not limited to clinically significant coronary artery disease, cardiac hypertrophy, cardiac ischemia, congestive heart failure, myocardial infarction, angina pectoris...
- Any clinically significant abnormal electrocardiogram (ECG) finding, such as findings suggestive of ischemia or infarct, complete bundle branch block, atrial fibrillation or other symptomatic arrhythmia, or...
- Resting QT interval with Fridericia's correction (QTcF) ≥ 450 msec at Screening, or inability to determine QTcF interval
- Presence of risk factors for torsades de pointes, including: long QT syndrome, uncontrolled hypokalemia or hypomagnesemia, history of cardiac failure, history of clinically significant/symptomatic bradycardia, family...
- Current use of psychotropic and/or potentially psychoactive prescription medications considered to the investigators are likely to interfere clinically with human subject's safety (i.e., contraindicated drug-drug...
- Current use of medications with serotonergic activity, as participants on these medications are at risk of serotonin syndrome or drug-drug interactions
- Medical contraindications to MRI procedures (e.g., ferromagnetic implants/foreign bodies, claustrophobia, etc.)
- Arterial Line Exclusion: Blood donation within eight weeks of the start of the study
- Arterial Line Exclusion: History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto)
- Participation in other research studies involving ionizing radiation within one year of the PET scans that would cause the subject to exceed the yearly dose limits followed by the Yale PET Center (21CFR361.1)
- Moderate to severe hepatic impairment (Child-Pugh B and C class)
- Use of enzyme inhibitors (UGT1A9, UGT1A10, MAO, and aldehyde or alcohol dehydrogenase).
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, 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 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, 25 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, 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.