Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
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 : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE February 7, 2022
First Posted Date  ICMJE February 16, 2022
Last Update Posted Date June 30, 2022
Estimated Study Start Date  ICMJE July 2022
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2022)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psilocybin for Opioid Use Disorder in Patients on Methadone Maintenance With Ongoing Opioid Use
Official Title  ICMJE A Randomized, Double-Blind Study of Psilocybin for Opioid Use Disorder in Patients on Methadone Maintenance With Ongoing Opioid Use
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Opioid Use Disorder
Intervention  ICMJE
  • Drug: Placebo
    Participants will receive placebo in a clinical setting.
  • Drug: Psilocybin
    Participants will receive 40mg psilocybin in a clinical setting.
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: Placebo
    • Drug: Psilocybin
  • 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.

    Interventions:
    • Drug: Placebo
    • Drug: Psilocybin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 7, 2022)
92
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sandeep Nayak, MD 410-550-0048 smn@jhmi.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05242029
Other Study ID Numbers  ICMJE IRB00251861
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Johns Hopkins University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Johns Hopkins University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthew W Johnson, PhD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP