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

NCT05242029 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: IRB00251861
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and 3-months after first experimental drug administration session

• 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.

  Baseline and 3-months after first experimental drug administration session

Study Arms (2)

Psilocybin

EXPERIMENTAL

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; Drug: Psilocybin

Placebo

PLACEBO COMPARATOR

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; Drug: Psilocybin

Interventions

Placebo DRUG

Participants will receive placebo in a clinical setting.

Placebo; Psilocybin

Psilocybin DRUG

Participants will receive 40mg psilocybin in a clinical setting.

Placebo; Psilocybin

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Related Publications (1)

• Nicholas CR, Horton DM, Malicki J, Baltes A, Hutson PR, Brown RT. Psilocybin for Opioid Use Disorder in Two Adults Stabilized on Buprenorphine: A Technical Report on Study Modifications and Preliminary Findings. Psychedelic Med (New Rochelle). 2023 Dec 13;1(4):253-261. doi: 10.1089/psymed.2023.0012. eCollection 2023 Dec.

  PMID: 40046866 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Matthew W Johnson, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, and outcomes assessors will be blinded for the duration of the trial.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 16, 2022
• Study Start: December 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share