RECRUITING

Adjunctive Effects of Psilocybin and a Formulation of Buprenorphine

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Conditions

Opioid Use DisorderPsilocybinBuprenorphineNaloxoneBuprenorphine-NaloxonePsilocybin-Assisted TherapyOpioidSubstance Use DisorderPsychedelic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Primary Aim: In participants with OUD, to characterize adverse events associated with adding two psilocybin doses to a stable buprenorphine-naloxone formulation. Secondary Aim: To evaluate the effect of psilocybin treatment on the effectiveness of a buprenorphine-naloxone maintenance therapy. Secondary Aim: To evaluate the effect of concurrent buprenorphine-naloxone use on the effects of psilocybin therapy. Descriptive Aim: To describe any changes in self-efficacy, quality of life, pain.

Official Title

Phase I Study of the Safety and Adjunctive Effects of Psilocybin in Adults With Opioid Use Disorder Maintained on a Buprenorphine/Naloxone Formulation

Quick Facts

Study Start:2021-01-13
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04161066

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 21 to 65 years
  2. * Able to read, speak, and understand spoken and written English
  3. * Diagnosis of moderate or severe opioid use disorder (OUD)
  4. * Current opioid misuse, with misuse occurring on at least 10 of the last 30 days. Misuse will be defined as either:
  5. 1. Use of illicit opioids, such as heroin or non-prescribed fentanyl; or use of an outpatient prescription opioid (such as oxycodone, morphine, or hydrocodone) through a route other than FDA approved (e.g. nasal, injected), and/or
  6. 2. Use of a prescription opioid via a route (e.g. nasal, injected, chewed) or for a purpose (e.g. intoxication, anxiety relief) other than that for which it was prescribed.
  7. * Able to achieve stable daily dose of a buprenorphine-naloxone formulation that controls opioid withdrawal symptoms
  8. * Persons of childbearing potential must agree to practice an effective means of contraception throughout their participation in the study, beginning at screening and throughout follow-up
  9. * Ability and willingness to adhere to study requirements, including attending all study visits, preparatory and follow-up sessions, and evaluations
  10. * Healthy kidney function
  11. * Able to provide contact information for a local support person. This person must be available during both 24-hour treatment and observation periods, and willing to provide the participant social/emotional support the day after each treatment and as needed during the dosing day and/or overnight observation period.
  1. * Currently prescribed and has taken buprenorphine or buprenorphine formulation (e.g., Suboxone®) for over four weeks immediately prior to initial study contact
  2. * Currently receiving pharmacotherapy of any duration with methadone
  3. * Current participation in a drug treatment court program or other legal supervision. Individuals who are under legal supervision will be advised that participating in this study could potentially violate terms of probation, parole, or extended supervision. Contact information for the individual's community supervision officer must be collected to confirm whether study participation may impact the potential participant's status on probation or parole
  4. * Inadequately treated hypertension
  5. * Current acute coronary syndrome or angina
  6. * Evidence of ischemic disease, cardiac conduction defects, and/or ventricular arrhythmias on screening ECG
  7. * History of heart transplant
  8. * Current insulin dependence, due to Type I or Type II diabetes
  9. * Urine drug test containing non-prescribed drugs of abuse
  10. * Any finding(s), based on the screening process, that the PI feels makes the study unsuitable for the participant

Contacts and Locations

Study Contact

PROTEA Research
CONTACT
608-444-2397
protea.research@mailplus.wisc.edu

Principal Investigator

Randall Brown, MD PhD
PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison

Study Locations (Sites)

University of Wisconsin
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

  • Randall Brown, MD PhD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-13
Study Completion Date2025-07

Study Record Updates

Study Start Date2021-01-13
Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

  • Psilocybin
  • Buprenorphine
  • Naloxone
  • Buprenorphine-Naloxone
  • Psilocybin-Assisted Therapy
  • Opioid
  • Substance Use Disorder
  • Psychedelic

Additional Relevant MeSH Terms

  • Opioid Use Disorder