New Haven, CTNCT06160284Now EnrollingIRB Ready

Opioid Use Disorder Clinical Trial in New Haven, CT

Access cutting-edge opioid use disorder treatment through this phase 1 clinical trial at a research site in New Haven. Study-provided care at no cost to qualified participants.

Sponsored by Yale University

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Expert Care in New Haven

Access opioid use disorder specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related opioid use disorder treatment provided free

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Check if you qualify for this opioid use disorder clinical trial in New Haven, CT

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to New Haven

    Convenient for CT residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New Haven site if eligible
  4. 4Begin participation

About This Opioid Use Disorder Study in New Haven

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.

Sponsor: Yale University

Who Can Participate

Inclusion 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, and for 90 days following the final drug dose for sperm. Dual contraceptive methods encompass the use of a barrier contraceptive, such as condoms, coupled with another effective method capable of preventing pregnancy, such as oral or parenteral contraceptives, intrauterine devices, spermicide, and the like.

Exclusion Criteria

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 does not take place during inpatient stay)
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 al., 1998), or another disorder that may interfere with the study's primary outcomes in the view of PI
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, coronary artery bypass graft or artificial heart valve, stroke, transient ischemic attack, or any clinically significant arrhythmia
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 predominantly non-sinus rhythm, at screening
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 history of idiopathic sudden death or congenital long QT syndrome, or concomitant use of a torsadogenic medication
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 interactions with psilocybin) or scientifically (i.e., likely to influence or alter outcomes of the study)
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).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New Haven?

Yes, this clinical trial (NCT06160284) has an active research site in New Haven, CT that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Opioid Use Disorder Treatment Options in New Haven, CT

If you're searching for opioid use disorder treatment options in New Haven, CT, this clinical trial (NCT06160284) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New Haven research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced opioid use disorder specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all opioid use disorder clinical trials near you to find additional studies recruiting in your area.

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