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1
Study Matches
Adjunctive Effects of Psilocybin and a Formulation of Buprenorphine
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.
Randall Brown, MD
All
21 Years to 65 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT04161066
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Inclusion Criteria:
• Aged 21 to 65 years
• Able to read, speak, and understand spoken and written English
• Diagnosis of moderate or severe opioid use disorder (OUD)
• Current opioid misuse, with misuse occurring on at least 10 of the last 30 days.
Misuse will be defined as either:
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
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.
• Able to achieve stable daily dose of a buprenorphine-naloxone formulation that
controls opioid withdrawal symptoms
• 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
• Ability and willingness to adhere to study requirements, including attending all study
visits, preparatory and follow-up sessions, and evaluations
• Healthy kidney function
• 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.
Exclusion Criteria:
• Currently prescribed and has taken buprenorphine or buprenorphine formulation (e.g.,
Suboxone®) for over four weeks immediately prior to initial study contact
• Currently receiving pharmacotherapy of any duration with methadone
• 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
• Inadequately treated hypertension
• Current acute coronary syndrome or angina
• Evidence of ischemic disease, cardiac conduction defects, and/or ventricular
arrhythmias on screening ECG
• History of heart transplant
• Current insulin dependence, due to Type I or Type II diabetes
• Urine drug test containing non-prescribed drugs of abuse
• Any finding(s), based on the screening process, that the PI feels makes the study
unsuitable for the participant
Opioid Use Disorder, Opioid abuse, Other, Addiction & SubstanceAbuse
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