Is NCT06786325 recruiting in Philadelphia, PA?

Yes, NCT06786325 is currently recruiting participants at its Philadelphia, PA location. This opioid use disorder clinical trial is actively enrolling qualified participants.

How do I join the opioid use disorder clinical trial in Philadelphia?

To join this clinical trial in Philadelphia, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Philadelphia clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Opioid Use Disorder Clinical Trial in Philadelphia, PA

About This Opioid Use Disorder Study in Philadelphia

Investigators will recruit 36 individuals on MAT for OUD for a double-blind, placebo-controlled design to determine whether PEX010 (25-mg/d) shows preliminary efficacy on neural correlates of neurocognition and on clinical outcomes. Participants will be randomized to either (single dose) 25-mg (PEX010-25 group) or 1-mg (PPEX010-1 group) PEX010 in a 2:1 ratio. Brain and behavioral testing sessions will precede Psilocybin (PSI) dosing day by 24-48 hours and will follow PSI dosing by 1 week. After an initial 6 phases, participants will come into the lab to submit a urine screen 2x/week and to complete a short survey in order to collect data on drug use, MAT adherence, and mental health symptoms. The investigators hypothesize the PEX010-25 (vs. PEX010-1) group will have better clinical outcomes (e.g., lower average percent positive urine drug screens, more late relapses, higher MAT adherence). There are research follow ups every three months out to one year post dose.

Sponsor: Anna Rose Childress, Ph.D.

Who Can Participate

Inclusion Criteria

An informed consent document voluntarily signed and dated by the subject.

Voluntary enrollment in the residential addiction treatment facility

Intention on residing within residential addiction treatment facility for the duration of the Pre/Post PSI dosing period.

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 received an injection of Sublocade® within the past month, or 3) are currently on methadone maintenance therapy and on a consistent dose for at least a week. Subject must provide a urine that is buprenorphine-positive (for subjects taking buprenorphine) or methadone-positive (for subjects taking methadone), during screening.

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 least 1 year post-menopausal) participants must agree to use an acceptable form of contraception (e.g. abstinence, intrauterine device, hormonal injection, hormonal implant, hormonal patch/ring/pill, condoms (male or female), etc.) during study participation and to continue its use for the duration of the study

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.

Exclusion Criteria

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. Patients with comorbid Alcohol Use Disorder will be accepted if their alcohol use disorder is not severe enough to require a medicated alcohol detoxiﬁcation.

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

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 antidepressant therapy).

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 a history of signiﬁcant active hepatitis, signiﬁcant hepatocellular injury as evidenced by elevated bilirubin levels (greater than 1.3), or, pulmonary, endocrine, cardiovascular, renal (creatinine clearance less than or equal to 60ml/min) or gastrointestinal disease, or current HIV infection, and/or clinically signiﬁcant levels (over 3.5x upper limit of normal) of aspartate aminotransferase (AST), and serumalanine aminotransferase (ALT).

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). An x-ray may be obtained to determine eligibility.

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).

\*Have the following cardiovascular conditions:

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.

\*At Screening or Baseline have elevated blood pressure as deﬁned as:

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

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 Philadelphia?

Yes, this clinical trial (NCT06786325) has an active research site in Philadelphia, PA 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 Philadelphia, PA

If you're searching for opioid use disorder treatment options in Philadelphia, PA, this clinical trial (NCT06786325) 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 Philadelphia research site is actively enrolling participants for this 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.

Opioid Use Disorder Clinical Trial in Philadelphia, PA

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