Psilocybin + Counseling for Opioid Use Disorder

Overseen By PROTEA 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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{11 12 13 14 15}

Research Team

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.

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.

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 Overview The 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

Group I: Open-label Experimental Treatment 1 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Psychedelic treatments, including psilocybin, ibogaine, and ayahuasca, show promise for improving psychological and psychosocial outcomes in individuals with substance use disorder (SUD) and substance misuse, but the evidence is limited and varied across different substances.

Currently, there is insufficient research to definitively establish the effectiveness of psychedelics for specific SUDs, highlighting the need for more rigorous studies with larger sample sizes and longer follow-up periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychedelic Treatments for Substance Use Disorder and Substance Misuse: A Mixed Methods Systematic Review. Sharma, R., Batchelor, R., Sin, J.[2023]

Buprenorphine is a safe and effective treatment for opioid dependence, particularly when combined with naloxone, which reduces its potential for abuse.

New regulations enable certified physicians to prescribe buprenorphine in their offices, significantly improving patient access to this important treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine maintenance: a new treatment for opioid dependence. Collins, GB., McAllister, MS.[2019]

A study involving 158 opioid users in New York City found that while 70% were aware of buprenorphine treatment, only 12% had actually been prescribed it, indicating a significant gap in treatment utilization.

Indirect exposure to buprenorphine, such as knowing someone who has used it, was linked to a higher interest in treatment (adjusted odds ratio of 2.65), suggesting that peer mentorship could be an effective strategy to increase buprenorphine uptake among opioid users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

I heard about it from a friend: assessing interest in buprenorphine treatment. Fox, AD., Shah, PA., Sohler, NL., et al.[2021]

Buprenorphine (Subutex) is recognized for its improved safety profile in treating opioid dependence, particularly by reducing the risk of overdose compared to other opioids.

Despite its safety advantages, there are still risks associated with the diversion of buprenorphine for misuse, as evidenced by cases of attempted intravenous injection, highlighting the need for strict dispensing protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Groin tissue necrosis requiring skin graft following parenteral abuse of buprenorphine tablets. Feeney, GF., Fairweather, P.[2013]

A survey of intravenous drug users in Helsinki revealed that 73% used buprenorphine as their primary drug, primarily for self-treating addiction or withdrawal symptoms.

The combination of buprenorphine and naloxone (Suboxone) was tried by 68% of respondents, but 80% reported negative experiences, suggesting that while it may help reduce buprenorphine abuse, its acceptance among users is low.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abuse liability of buprenorphine-naloxone tablets in untreated IV drug users. Alho, H., Sinclair, D., Vuori, E., et al.[2015]

Integrating buprenorphine treatment for opioid dependence with HIV primary care can optimize health outcomes for patients dealing with both issues, as supported by the CDC's strategic plan.

The review outlines four effective models for this integration: on-site addiction/HIV specialist treatment, HIV primary care physician model, nonphysician health professional model, and community outreach model, which can help facilitate better care for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial strategies for integrating buprenorphine into HIV care settings in the United States. Sullivan, LE., Bruce, RD., Haltiwanger, D., et al.[2019]

The study will involve 280 adults with opioid use disorder and aims to improve adherence to buprenorphine-naloxone treatment through two psychological interventions: contingency management (CM) and brief motivational interviewing plus substance-free activities and mindfulness (BSM).

The primary goal is to assess which intervention is more effective in promoting medication adherence, measured by attendance at physician appointments and the presence of buprenorphine in urine toxicology, with follow-up occurring 8 months after randomization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Peter, SC., Murphy, JG., Witkiewitz, K., et al.[2023]

Buprenorphine is a safe and effective medication for treating opioid use disorder (OUD) in individuals with HIV, helping to reduce cravings and overdose risks while improving HIV care outcomes.

Despite its proven benefits, there is a significant gap in the implementation of buprenorphine prescribing in HIV care settings, highlighting the need for HIV clinicians to obtain waivers and integrate OUD education into their training.

NCBI (Pubmed)

pubmed.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. Fujita, AW., Wilson, JD., Kennedy, AJ.[2022]

A survey of 476 residency program directors revealed that while 76.9% of residents frequently manage patients with opioid use disorder (OUD), only 23.5% of programs dedicate significant curricular time (12+ hours) to addiction medicine, and only 35.9% encourage training in office-based opioid treatment (OBOT).

Despite the majority of program directors believing that increased training in OBOT would improve access to treatment for OUD, barriers such as a lack of qualified preceptors and competing curricular priorities hinder the implementation of OBOT training in residency programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training in office-based opioid treatment with buprenorphine in US residency programs: A national survey of residency program directors. Tesema, L., Marshall, J., Hathaway, R., et al.[2019]

Over 400 clinicians participated in free buprenorphine training, but only 30 out of 101 attending physicians applied for the necessary x-waiver to prescribe it, highlighting a significant gap between training and actual prescribing.

Despite the removal of training requirements for prescribing buprenorphine, the low number of physicians who went on to prescribe it suggests that additional cultural and systemic changes are needed to improve access to treatment for opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Access to Medications for Opioid Use Disorder in Primary Care: Removing the Training Requirement May Not Be Enough. Russell, HA., Sanders, M., Meyer, JKV., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Psychedelic therapy for smoking cessation: Qualitative analysis of participant accounts. [2019]

2. Hungary pubmed.ncbi.nlm.nih.gov

Psilocybin use patterns and perception of risk among a cohort of Black individuals with Opioid Use Disorder. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Psilocybin Therapeutic Research: The Present and Future Paradigm. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Associations between classic psychedelics and opioid use disorder in a nationally-representative U.S. adult sample. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Psychedelic Treatments for Substance Use Disorder and Substance Misuse: A Mixed Methods Systematic Review. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Buprenorphine maintenance: a new treatment for opioid dependence. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

I heard about it from a friend: assessing interest in buprenorphine treatment. [2021]

8. Australia pubmed.ncbi.nlm.nih.gov

Groin tissue necrosis requiring skin graft following parenteral abuse of buprenorphine tablets. [2013]

9. Ireland pubmed.ncbi.nlm.nih.gov

Abuse liability of buprenorphine-naloxone tablets in untreated IV drug users. [2015]

10. Netherlands pubmed.ncbi.nlm.nih.gov

The Naloxone Component of Buprenorphine/Naloxone: Discouraging Misuse, but at What Cost? [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Initial strategies for integrating buprenorphine into HIV care settings in the United States. [2019]

12. England pubmed.ncbi.nlm.nih.gov

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 States pubmed.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 States pubmed.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 States pubmed.ncbi.nlm.nih.gov

Increasing Access to Medications for Opioid Use Disorder in Primary Care: Removing the Training Requirement May Not Be Enough. [2021]