Adjunctive Effects of Psilocybin and Buprenorphine

• Status: Recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Aim: In participants with OUD in early or sustained full recovery on buprenorphine/naloxone therapy, to characterize adverse events associated with adding two psilocybin doses to a stable buprenorphine/naloxone regimen.

Secondary Aim: To evaluate the effect of psilocybin treatment on the effectiveness of 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: Heffter Research Institute
• Treatments: Buprenorphine; Psilocybin

Criteria

Inclusion Criteria:

• Aged 21 to 65 years.

• Able to read, speak, and understand spoken and written English.

• Diagnosis of opioid use disorder, with daily sublingual buprenorphine/naloxone. Stability will be verified by direct communication with the participant's community-based prescriber.

• Females 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 of the 24-hour treatment and observation periods, and willing to provide the participant transportation from the site after each treatment and observation period.

Exclusion Criteria:

• Current participation in a drug treatment court program or other legal supervision.

• 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.

• Current use of neuroleptic medications.

• Current use of intramuscular naltrexone.

• 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.