~0 spots leftby Jul 2025

Psilocybin + Counseling for Opioid Use Disorder

AB
DH
DH
PR
Overseen ByPROTEA Research
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: University of Wisconsin, Madison
Must be taking: Buprenorphine-naloxone
Must not be taking: Methadone
Disqualifiers: Hypertension, Heart disease, Diabetes, others
No Placebo Group
Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on a stable dose of buprenorphine-naloxone. If you are currently on methadone or have been on buprenorphine for over four weeks before the study, you cannot participate.

What data supports the effectiveness of psilocybin as a drug for treating Opioid Use Disorder?

Research suggests that psilocybin, a component of 'magic mushrooms', may help reduce the odds of Opioid Use Disorder. A study found that people who had used psilocybin had lower chances of having this disorder, indicating potential benefits of psilocybin in treating substance use issues.12345

Is the combination of psilocybin and counseling safe for treating opioid use disorder?

Buprenorphine, often used in combination with naloxone, is considered safe and effective for treating opioid dependence, with a low potential for abuse. However, there is no specific safety data available for the combination of psilocybin and counseling for opioid use disorder in the provided research.678910

How is the drug Psilocybin + Counseling for Opioid Use Disorder different from other treatments?

This treatment is unique because it combines psilocybin, a psychedelic compound, with counseling, offering a novel approach compared to traditional medications like buprenorphine, which is typically used alone to reduce opioid cravings and prevent overdose.1112131415

Research Team

RB

Randall Brown, MD PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

Adults aged 21-65 with opioid use disorder (OUD) who are on a stable buprenorphine-naloxone treatment. Participants must have healthy kidneys, be able to understand English, and agree to use effective contraception. They should not be on methadone, under legal supervision that prohibits study participation, or have certain heart conditions or insulin-dependent diabetes.

Inclusion Criteria

I am between 21 and 65 years old.
I can provide a contact for someone who will support me during and after my treatment.
My kidneys are functioning well.
See 9 more

Exclusion Criteria

I am currently experiencing heart-related chest pain.
Urine drug test containing non-prescribed drugs of abuse
I am currently dependent on insulin for my diabetes.
See 7 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Preparatory Counseling

Participants undergo at least 6 hours of preparatory counseling and preparation for psilocybin dosing

1 week
Multiple sessions (in-person)

Treatment

Participants receive two oral doses of psilocybin, approximately 4 weeks apart, with observation and integration sessions

5 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and changes in opioid craving

4 weeks
1 visit (in-person), ongoing monitoring

Treatment Details

Interventions

  • Buprenorphine (Opioid)
  • Psilocybin (Psychedelic)
Trial OverviewThe trial is testing the safety and effects of adding two doses of psilocybin to ongoing buprenorphine-naloxone therapy for OUD. It aims to see if psilocybin can improve self-efficacy, quality of life, and pain while maintaining the effectiveness of buprenorphine-naloxone.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Open-labelExperimental Treatment1 Intervention
Psilocybin with facilitated counseling: Psilocybin will be administered in the form of capsules, taken orally with water. Each participant will receive 2 doses, approximately 4 weeks apart.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

Heffter Research Institute

Collaborator

Trials
15
Recruited
520+

Etheridge Foundation

Collaborator

Trials
3
Recruited
50+

Findings from Research

In a pilot study involving 15 participants, those who underwent psilocybin-facilitated smoking cessation reported significant insights into their self-identity and reasons for smoking, which contributed to their ability to quit smoking.
Participants experienced lasting positive changes beyond smoking cessation, such as increased altruism and pro-social behavior, suggesting that the therapeutic effects of psilocybin may extend beyond the immediate treatment context.
Psychedelic therapy for smoking cessation: Qualitative analysis of participant accounts.Noorani, T., Garcia-Romeu, A., Swift, TC., et al.[2019]
A study involving 28 Black individuals with Opioid Use Disorder revealed that while most had heard of psilocybin, only a small number had actually used it, indicating limited exposure to this potential treatment.
Despite a willingness to consider psilocybin therapy, over 80% of participants perceived significant risks associated with its use, highlighting the need for culturally informed education and outreach to improve understanding and acceptance of psilocybin as a treatment option.
Psilocybin use patterns and perception of risk among a cohort of Black individuals with Opioid Use Disorder.Clifton, JM., Belcher, AM., Greenblatt, AD., et al.[2023]
Lifetime use of psilocybin is associated with significantly lower odds of developing opioid use disorder (OUD), with an adjusted odds ratio of 0.70 based on a large sample of 214,505 participants from the National Survey on Drug Use and Health.
Psilocybin use was linked to reduced odds of meeting seven out of eleven DSM-IV criteria for OUD, suggesting its potential as a therapeutic option, although further clinical trials are necessary to establish a causal relationship.
Associations between classic psychedelics and opioid use disorder in a nationally-representative U.S. adult sample.Jones, G., Ricard, JA., Lipson, J., et al.[2022]

References

Psychedelic therapy for smoking cessation: Qualitative analysis of participant accounts. [2019]
Psilocybin use patterns and perception of risk among a cohort of Black individuals with Opioid Use Disorder. [2023]
Psilocybin Therapeutic Research: The Present and Future Paradigm. [2021]
Associations between classic psychedelics and opioid use disorder in a nationally-representative U.S. adult sample. [2022]
Psychedelic Treatments for Substance Use Disorder and Substance Misuse: A Mixed Methods Systematic Review. [2023]
Buprenorphine maintenance: a new treatment for opioid dependence. [2019]
I heard about it from a friend: assessing interest in buprenorphine treatment. [2021]
Groin tissue necrosis requiring skin graft following parenteral abuse of buprenorphine tablets. [2013]
Abuse liability of buprenorphine-naloxone tablets in untreated IV drug users. [2015]
The Naloxone Component of Buprenorphine/Naloxone: Discouraging Misuse, but at What Cost? [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Initial strategies for integrating buprenorphine into HIV care settings in the United States. [2019]
Use of a sequential multiple assignment randomized trial to test contingency management and an integrated behavioral economic and mindfulness intervention for buprenorphine-naloxone medication adherence for opioid use disorder. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
A Call to Action: Integration of Buprenorphine Prescribing Into the Care of Persons With Human Immunodeficiency Virus and Opioid Use Disorder. [2022]
14.United Statespubmed.ncbi.nlm.nih.gov
Training in office-based opioid treatment with buprenorphine in US residency programs: A national survey of residency program directors. [2019]
15.United Statespubmed.ncbi.nlm.nih.gov
Increasing Access to Medications for Opioid Use Disorder in Primary Care: Removing the Training Requirement May Not Be Enough. [2021]