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Psilocybin for Opioid Use Disorder in Patients on Methadone Maintenance With Ongoing Opioid Use

Primary Purpose

Opioid Use Disorder

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Placebo

Psilocybin

About this trial

This is an interventional treatment trial for Opioid Use Disorder

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 21-70 years
Have OUD
Enrolled in a methadone maintenance program for at least 3 months
Urine toxicology positive for methadone
Urine toxicology positive for an additional opioid
Access to stable housing
Read, write, and speak English
Be judged by study team clinicians to be at low risk for suicidality
Have limited lifetime use of classic psychedelics (no use in the past 5 years; total classic psychedelic use less than 20 times)
Are local to the Baltimore area

Exclusion Criteria:

Women who are pregnant, nursing, or not practicing an effective means of birth control
Cardiovascular conditions: hypertension with resting blood pressure systolic >140 or diastolic >90, angina, a clinically significant ECG abnormality (e.g., atrial fibrillation, corrected QT interval > 450), transient ischemic attack in the last 6 months stroke, peripheral or pulmonary vascular disease
Epilepsy
Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
Currently taking a prescribed psychoactive medication on a daily basis (except methadone)
Currently taking on a daily basis any medications (including herbal substances and supplements) with a central nervous system effect on serotonin, including serotonin-reuptake inhibitors and monoamine oxidase inhibitors.
o For individuals who have intermittent or as needed use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.
Currently taking efavirenz, Acetaldehyde dehydrogenase inhibitors such as disulfiram (Antabuse), Alcohol dehydrogenase inhibitors, or Uridine 5'-diphospho-glucuronosyltransferase Family 1 Member A9 (UGT1A9) inhibitors or UGT1A10 inhibitors such as phenytoin, regorafenib, eltrombopag.
Have a seizure disorder, multiple sclerosis, history of significant head trauma, central nervous system tumor, movement disorders or any neurodegenerative condition.
Morbidly obese (>100 lbs above idea body weight, or BMI >=40, or BMI >=35 with high blood pressure or diabetes)
Body weight < 45kg
Recent (within past 12 months) or extensive history of classic psychedelic use (>19 lifetime uses).
Physiological dependence on benzodiazepines or alcohol
Abnormal screening labs: values for hemoglobin, white blood count, creatinine, potassium, and bilirubin outside of the normal lab reference rage. Transaminases greater than x2 the upper limit of normal lab reference range.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Psilocybin

Placebo

Arm Description

Participants will be administered 40mg of psilocybin in a clinical setting. Psilocybin is administered orally as a capsule and taken with water. At 3 months, half will be randomized to receive a blinded dose of psilocybin 40mg and half a blinded dose of placebo.

Participants will be administered placebo in a clinical setting. Placebo is administered orally as a capsule taken with water. At 3 months, participants will receive a blinded dose of psilocybin 40mg.

Outcomes

Primary Outcome Measures

Change in non-methadone opioid use as assessed by urine toxicology

The primary outcome variable will be change in non-methadone opioid use as verified by urine toxicology at each visit.

Change in non-methadone opioid use as assessed by the Timeline Follow Back self report

The primary outcome variable will be change in non-methadone opioid use as verified by Timeline Follow Back (TLFB) of mean number of days of non-methadone opioid use. The TLFB is a widely used, standardized, calendar-based retrospective self-report assessment to quantify daily opioid use.

Secondary Outcome Measures

Full Information

NCT ID

NCT05242029

First Posted

February 7, 2022

Last Updated

June 16, 2023

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT05242029

Brief Title

Psilocybin for Opioid Use Disorder in Patients on Methadone Maintenance With Ongoing Opioid Use

Official Title

A Randomized, Double-Blind Study of Psilocybin for Opioid Use Disorder in Patients on Methadone Maintenance With Ongoing Opioid Use

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2023 (Anticipated)

Primary Completion Date

February 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study will investigate whether psilocybin administered under supportive conditions can reduce illicit opioid use and improve quality of life in individuals with Opioid Use Disorder (OUD) in Methadone Maintenance Treatment (MMT) who are concurrently using other opioids illicitly.

Detailed Description

This randomized double-blind placebo-controlled trial will investigate whether 2 doses of psilocybin administered under supportive conditions can reduce illicit opioid use (assessed by self-report and urine toxicology) and improve quality of life as measured by World Health Organization Quality of Life (WHOQOL-BREF) in individuals with OUD in MMT who are concurrently using other opioids illicitly. In addition, the investigators will investigate secondary outcomes including whether psilocybin under supportive conditions improves mood, reduces use of tobacco and other non-opioid drugs, improves chronic pain and sleep. Ninety-two participants aged 21-70 who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for OUD, are enrolled in a MMT program for at least 3 months, and have urine toxicology positive for methadone and another opioid will be recruited from the community and complete all study procedures. Participants will be randomized to an active group or control group (46 per group). Participants will undergo a total of 2 dosing sessions (whether psilocybin or placebo). The active group will receive 40mg psilocybin first. All participants will receive a second dosing session at three months. The active group will be further randomized, with half receiving 40mg psilocybin, and half receiving placebo at three months to test a secondary hypothesis that two doses of psilocybin are more effective in treating OUD than a single dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid Use Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Model Description

Participants will be randomized to an active group or control group (46 per group). Participants will undergo a total of 2 dosing sessions (whether psilocybin or placebo). The active group will receive 40mg psilocybin first. All participants will receive a second dosing session at three months. The active group will be further randomized, with half receiving 40mg psilocybin, and half receiving placebo at three months.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Participants, care providers, investigators, and outcomes assessors will be blinded for the duration of the trial.

Allocation

Randomized

Enrollment

92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Psilocybin

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants will receive placebo in a clinical setting.

Intervention Type

Drug

Intervention Name(s)

Psilocybin

Intervention Description

Participants will receive 40mg psilocybin in a clinical setting.

Primary Outcome Measure Information:

Title

Change in non-methadone opioid use as assessed by urine toxicology

Description

The primary outcome variable will be change in non-methadone opioid use as verified by urine toxicology at each visit.

Time Frame

Baseline and 3-months after first experimental drug administration session

Title

Change in non-methadone opioid use as assessed by the Timeline Follow Back self report

Description

Time Frame

Baseline and 3-months after first experimental drug administration session

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 21-70 years Have OUD Enrolled in a methadone maintenance program for at least 3 months Urine toxicology positive for methadone Urine toxicology positive for an additional opioid Access to stable housing Read, write, and speak English Be judged by study team clinicians to be at low risk for suicidality Have limited lifetime use of classic psychedelics (no use in the past 5 years; total classic psychedelic use less than 20 times) Are local to the Baltimore area Exclusion Criteria: Women who are pregnant, nursing, or not practicing an effective means of birth control Cardiovascular conditions: hypertension with resting blood pressure systolic >140 or diastolic >90, angina, a clinically significant ECG abnormality (e.g., atrial fibrillation, corrected QT interval > 450), transient ischemic attack in the last 6 months stroke, peripheral or pulmonary vascular disease Epilepsy Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia Currently taking a prescribed psychoactive medication on a daily basis (except methadone) Currently taking on a daily basis any medications (including herbal substances and supplements) with a central nervous system effect on serotonin, including serotonin-reuptake inhibitors and monoamine oxidase inhibitors. o For individuals who have intermittent or as needed use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose. Currently taking efavirenz, Acetaldehyde dehydrogenase inhibitors such as disulfiram (Antabuse), Alcohol dehydrogenase inhibitors, or Uridine 5'-diphospho-glucuronosyltransferase Family 1 Member A9 (UGT1A9) inhibitors or UGT1A10 inhibitors such as phenytoin, regorafenib, eltrombopag. Have a seizure disorder, multiple sclerosis, history of significant head trauma, central nervous system tumor, movement disorders or any neurodegenerative condition. Morbidly obese (>100 lbs above idea body weight, or BMI >=40, or BMI >=35 with high blood pressure or diabetes) Body weight < 45kg Recent (within past 12 months) or extensive history of classic psychedelic use (>19 lifetime uses). Physiological dependence on benzodiazepines or alcohol Abnormal screening labs: values for hemoglobin, white blood count, creatinine, potassium, and bilirubin outside of the normal lab reference rage. Transaminases greater than x2 the upper limit of normal lab reference range.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Matthew W Johnson, PhD

Phone

4105500056

mwj@jhu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Gideon Naude, PhD

Phone

4105502774

gnaude1@jhmi.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew W Johnson, PhD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Psilocybin for Opioid Use Disorder in Patients on Methadone Maintenance With Ongoing Opioid Use

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