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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06160284




Registration number
NCT06160284
Ethics application status
Date submitted
28/11/2023
Date registered
7/12/2023

Titles & IDs
Public title
Exploration of Synaptotrophic Effects of Psilocybin in Opioid Use Disorder (OUD)
Scientific title
Exploration of Synaptotrophic Effects of Psilocybin in Opioid Use Disorder (OUD)
Secondary ID [1] 0 0
P30DA046345
Secondary ID [2] 0 0
2000036178
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid Use Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Psilocybin

Experimental: Current OUD diagnosis + psilocybin - All participants will receive a \[11C\]-UCB-J PET scan and fMRI with in 1-2 weeks pre and post treatment with one dose of Psilocybin. Intravenous lines will be used for phlebotomy and administration of the \[11C\]-UCB-J radiotracer. On the PET scanning day, a radial arterial catheter may be inserted.


Treatment: Drugs: Psilocybin
Participants will receive a single dose of psilocybin administered in 20 mg or 25 mg doses depending on the participant's weight: 20 mg (among participants \< 70 kg) or 25 mg (among participants \>70 kg). Participants will be administered psilocybin at CNRU, within 1-2 weeks of the baseline \[11C\]-UCB-J PET.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Synaptic Density
Timepoint [1] 0 0
baseline and 1-2 weeks post treatment
Primary outcome [2] 0 0
Association between VT and BPND
Timepoint [2] 0 0
up to 12 weeks
Primary outcome [3] 0 0
Time to relapse
Timepoint [3] 0 0
up to 12 weeks
Primary outcome [4] 0 0
Urine toxicology post treatment
Timepoint [4] 0 0
up to 12 weeks
Secondary outcome [1] 0 0
Change in vital signs- heart rate (HR)
Timepoint [1] 0 0
immediately prior to psilocybin treatment with and up to 5 hours+ post treatment
Secondary outcome [2] 0 0
Change in vital signs- respiratory rate (RR)
Timepoint [2] 0 0
immediately prior to psilocybin treatment with and up to 5 hours+ post treatment
Secondary outcome [3] 0 0
Change in vital signs- oxygen saturation
Timepoint [3] 0 0
immediately prior to psilocybin treatment with and up to 5 hours+ post treatment
Secondary outcome [4] 0 0
Change in vital signs- systolic blood pressure
Timepoint [4] 0 0
immediately prior to psilocybin treatment with and up to 5 hours+ post treatment
Secondary outcome [5] 0 0
Change in vital signs- diastolic blood pressure
Timepoint [5] 0 0
immediately prior to psilocybin treatment with and up to 5 hours+ post treatment
Secondary outcome [6] 0 0
Change in vital signs- body temperature
Timepoint [6] 0 0
immediately prior to psilocybin treatment with and up to 5 hours+ post treatment
Secondary outcome [7] 0 0
Total number of participants with treatment emergent adverse events
Timepoint [7] 0 0
up to 12 weeks
Secondary outcome [8] 0 0
Change in Profile of Mood States (POMS) Score
Timepoint [8] 0 0
approximately 30 and 150 minutes post Psilocybin treatment
Secondary outcome [9] 0 0
Change in Clinical Opioid Withdrawal Scale (COWS) Score
Timepoint [9] 0 0
approximately 30 and 150 minutes post Psilocybin treatment
Secondary outcome [10] 0 0
Change in Subjective Opioid Withdrawal Scale (SOWS) Score
Timepoint [10] 0 0
approximately 30 and 150 minutes post Psilocybin treatment
Secondary outcome [11] 0 0
Change in Opioid Symptom Checklist (OSC)
Timepoint [11] 0 0
approximately 30 and 150 minutes post Psilocybin treatment

Eligibility
Key inclusion criteria
* 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;
* For females, a negative serum pregnancy (beta-HCG) test.
Minimum age
21 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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), 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
* 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;
* 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 (male) or = 470 msec (female) 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)
* 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).

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2027
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut

Funding & Sponsors
Primary sponsor type
Other
Name
Yale University
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute on Drug Abuse (NIDA)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gustavo Angarita, MD, MHS
Address 0 0
Yale University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gustavo Angarita, MD, MHS
Address 0 0
Country 0 0
Phone 0 0
(203) 974-7536
Fax 0 0
Email 0 0
gustavo.angarita@yale.edu
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06160284