We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05242029
Recruitment Status : Not yet recruiting
First Posted : February 16, 2022
Last Update Posted : August 24, 2022
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Opioid Use Disorder Drug: Placebo Drug: Psilocybin Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participants, care providers, investigators, and outcomes assessors will be blinded for the duration of the trial.
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study of Psilocybin for Opioid Use Disorder in Patients on Methadone Maintenance With Ongoing Opioid Use
Estimated Study Start Date : October 2022
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : December 2024

Arm Intervention/treatment
Experimental: Psilocybin

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.

Drug: Placebo
Participants will receive placebo in a clinical setting.

Drug: Psilocybin
Participants will receive 40mg psilocybin in a clinical setting.

Placebo Comparator: 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.

Drug: Placebo
Participants will receive placebo in a clinical setting.

Drug: Psilocybin
Participants will receive 40mg psilocybin in a clinical setting.




Primary Outcome Measures :
  1. Change in non-methadone opioid use as assessed by urine toxicology [ Time Frame: Baseline and 3-months after first experimental drug administration session ]
    The primary outcome variable will be change in non-methadone opioid use as verified by urine toxicology at each visit.

  2. Change in non-methadone opioid use as assessed by the Timeline Follow Back self report [ Time Frame: Baseline and 3-months after first experimental drug administration session ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05242029


Contacts
Layout table for location contacts
Contact: Sandeep Nayak, MD 410-550-0048 smn@jhmi.edu

Sponsors and Collaborators
Johns Hopkins University
Investigators
Layout table for investigator information
Principal Investigator: Matthew W Johnson, PhD Johns Hopkins University
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT05242029    
Other Study ID Numbers: IRB00251861
First Posted: February 16, 2022    Key Record Dates
Last Update Posted: August 24, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Opioid-Related Disorders
Substance-Related Disorders
Narcotic-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Psilocybin
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs