Psilocybin + Counseling for Opioid Use Disorder
Recruiting in Palo Alto (17 mi)
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.
12345Is 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.
678910How 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.
1112131415Eligibility 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.
+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.
+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
Participant Groups
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.
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.
Buprenorphine is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Buprenorphine for:
- Moderate to severe opioid addiction (dependence)
🇪🇺 Approved in European Union as Buprenorphine for:
- Opioid dependence
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of WisconsinMadison, WI
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Who Is Running the Clinical Trial?
University of Wisconsin, MadisonLead Sponsor
Heffter Research InstituteCollaborator
Etheridge FoundationCollaborator
References
Psychedelic therapy for smoking cessation: Qualitative analysis of participant accounts. [2019]Recent pilot trials suggest feasibility and potential efficacy of psychedelic-facilitated addiction treatment interventions. Fifteen participants completed a psilocybin-facilitated smoking cessation pilot study between 2009 and 2015.
Psilocybin use patterns and perception of risk among a cohort of Black individuals with Opioid Use Disorder. [2023]There is growing evidence that psilocybin, a serotonergic psychedelic substance, may be useful in the treatment of substance use disorders. However, there is a lack of data on the beliefs and attitudes towards psilocybin amongst Black individuals diagnosed with Opioid Use Disorder (OUD). This study characterized psilocybin use patterns and perception of risk amongst a cohort of Black individuals diagnosed with OUD.
Psilocybin Therapeutic Research: The Present and Future Paradigm. [2021]Psilocybin, an active component in "magic mushroom", may have the potential to meet the therapeutic needs for a number of indications without the addictiveness and overdose risk of other mind-altering drugs, such as cocaine, heroin, alcohol, methamphetamine, and so forth. The need for new therapies is urgent because addiction, overdose, and suicide deaths have risen throughout the United States and around the world. Anecdotal and contemporary pharmacological reports have provided some indication about the therapeutic use of psilocybin for the treatment of mental health disorders such as major depressive disorder and addiction disorders. In this Viewpoint, I summarize the current state of psilocybin therapeutic research and attempt to provide some insight into future directions on which the scientific community may wish to focus.
Associations between classic psychedelics and opioid use disorder in a nationally-representative U.S. adult sample. [2022]Opioid use disorder (OUD) is a major source of morbidity and mortality in the U.S. and there is a pressing need to identify additional treatments for the disorder. Classic psychedelics (psilocybin, peyote, mescaline, LSD) have been linked to the alleviation of various substance use disorders and may hold promise as potential treatments for OUD. The aim of this study was to assess whether the aforementioned classic psychedelic substances conferred lowered odds of OUD. Furthermore, this study aimed to replicate and extend findings from Pisano et al. (2017) who found classic psychedelic use to be linked to lowered odds of OUD in a nationally representative sample. We used recent data from the National Survey on Drug Use and Health (2015-2019) (N = 214,505) and multivariable logistic regression to test whether lifetime use (yes/no) of classic psychedelics was associated with lowered odds of OUD. Lifetime psilocybin use was associated with lowered odds of OUD (aOR: 0.70; 95% CI [0.60, 0.83]). No other substances, including other classic psychedelics, were associated with lowered odds of OUD. Additionally, sensitivity analyses revealed psilocybin use to be associated with lowered odds of seven of the 11 DSM-IV criteria for OUD (aOR range: 0.66-0.83). Future clinical trials and longitudinal studies are needed to determine whether these associations are causal.
Psychedelic Treatments for Substance Use Disorder and Substance Misuse: A Mixed Methods Systematic Review. [2023]Renewed interest in psychedelic substances in the 21st century has seen the exploration of psychedelic treatments for various psychiatric disorders including substance use disorder (SUD). This review aimed to assess the effectiveness of psychedelic treatments for people with SUD and those falling below diagnostic thresholds (i.e. substance misuse). We systematically searched 11 databases, trial registries, and psychedelic organization websites for empirical studies examining adults undergoing psychedelic treatment for SUD or substance misuse, published in the English language, between 2000 and 2021. Seven studies investigating treatment using psilocybin, ibogaine, and ayahuasca, alone or adjunct with psychotherapy reported across 10 papers were included. Measures of abstinence, substance use, psychological and psychosocial outcomes, craving, and withdrawal reported positive results, however, this data was scarce among studies examining a wide range of addictions including opioid, nicotine, alcohol, cocaine and unspecified substance. The qualitative synthesis from three studies described subjective experience of psychedelic-assisted treatments enhanced self-awareness, insight, and confidence. At present, there is no sufficient research evidence to suggest effectiveness of any of the psychedelics on any specific substance use disorder or substance misuse. Further research using rigorous effectiveness evaluation methods with larger sample sizes and longer-term follow-up is required.
Buprenorphine maintenance: a new treatment for opioid dependence. [2019]Buprenorphine (Subutex) is a safe and effective treatment for opioid dependence, and has very low potential for abuse, especially when it is combined with naloxone (Narcan) in a single sublingual tablet (Suboxone). New regulations allow physicians who are certified in buprenorphine therapy to offer it in their offices, a development that can substantially increase patient access to treatment.
I heard about it from a friend: assessing interest in buprenorphine treatment. [2021]In the United States, opioid abuse and dependence continue to be a growing problem, whereas treatment for opioid abuse and dependence remains fairly static. Buprenorphine treatment for opioid dependence is safe and effective but underutilized. Prior research has demonstrated low awareness and use of buprenorphine among marginalized groups. This study investigates syringe exchange participants' awareness of, exposure to, and interest in buprenorphine treatment.
Groin tissue necrosis requiring skin graft following parenteral abuse of buprenorphine tablets. [2013]In May 2002 Buprenorphine (Subutex) was listed on the Australian Pharmaceutical Benefits Schedule for treatment in opioid dependence. In addition to broadening treatment options, buprenorphine has the advantage of an improved safety profile. The risk of overdose is lessened but other risks remain due to diversion. French experience reports widespread deviation of buprenorphine sublingual tablets to intravenous injection. We report a case of attempted parenteral administration of buprenorphine tablets. Stringent protocols for dispensing are appropriate.
Abuse liability of buprenorphine-naloxone tablets in untreated IV drug users. [2015]Buprenorphine (Subutex) is widely abused in Finland. A combination of buprenorphine plus naloxone (Suboxone) has been available since late 2004, permitting a comparison of the abuse of the two products among untreated intravenous (IV) users. A survey was distributed to attendees at a Helsinki needle exchange program over 2-weeks in April, 2005, At least 30% were returned anonymously. Survey variables included: years of prior IV opioid abuse, years of buprenorphine abuse, frequency, dosage, route of administration and reasons for use, concomitant IV abuse of other substances and amount paid on the street for both buprenorphine and buprenorphine+naloxone. Buprenorphine was the most frequently used IV drug for 73% of the respondents. More than 75% said they used IV buprenorphine to self-treat addiction or withdrawal. Most (68%) had tried the buprenorphine+naloxone combination IV, but 80% said they had a "bad" experience. Its street price was less than half that of buprenorphine alone. The buprenorphine+naloxone combination appears to be a feasible tool, along with easier access to addiction treatment, for decreasing IV abuse of buprenorphine.
The Naloxone Component of Buprenorphine/Naloxone: Discouraging Misuse, but at What Cost? [2023]Because opioid overdose deaths in the United States continue to rise, it is critical to increase patient access to buprenorphine, which treats opioid use disorder and reduces mortality. An underrecognized barrier to buprenorphine treatment (both for maintenance and treatment of acute withdrawal) is limited access to buprenorphine monoproduct. In the United States, buprenorphine is primarily prescribed as a combination product also containing naloxone, added to reduce the potential for misuse. Because naloxone has relatively low sublingual bioavailability compared with buprenorphine, adverse effects are generally considered mild and rare. The authors' clinical experience, however, suggests that adverse effects may be less benign than generally accepted and can have negative effects for the patient, the provider-patient relationship, and the health care system as a whole. The insistence on prescribing combination product can foster stigma and mistrust, creating barriers to care and increased risk of overdose and death.
Initial strategies for integrating buprenorphine into HIV care settings in the United States. [2019]The Centers for Disease Control and Prevention's HIV Prevention Strategic Plan Through 2005 advocated for increasing the proportion of persons with human immunodeficiency virus (HIV) infection and in need of substance abuse treatment who are successfully linked to services for these 2 conditions. There is evidence that integrating care for HIV infection and substance abuse optimizes outcomes for patients with both disorders. Buprenorphine, a recently approved medication for the treatment of opioid dependence in physicians' offices, provides the opportunity to integrate the treatment of HIV infection and substance abuse in one clinical setting, yet little information exists on the models of care that will most successfully facilitate this integration. To promote the uptake of this type of integrated care, the current review provides a description of 4 recently implemented models for combining buprenorphine treatment with HIV primary care: (1) an on-site addiction/HIV specialist treatment model; (2) a HIV primary care physician model; (3) a nonphysician health professional model; and (4) a community outreach model.
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]Buprenorphine-naloxone is a medication shown to improve outcomes for individuals seeking treatment for opioid use disorder (OUD); however, outcomes are limited by low medication adherence rates. This is especially true during the early stages of treatment.
A Call to Action: Integration of Buprenorphine Prescribing Into the Care of Persons With Human Immunodeficiency Virus and Opioid Use Disorder. [2022]During the coronavirus disease 2019 (COVID-19) pandemic, we also experienced a worsening opioid overdose epidemic. Untreated opioid use disorder (OUD) in persons with human immunodeficiency virus (HIV) is associated with worse HIV-related outcomes. Buprenorphine is a safe, evidence-based medication for OUD and is effective in reducing opioid craving and overdose and improving outcomes along the HIV care continuum. Despite the longstanding evidence supporting the benefits of buprenorphine, there remains an implementation gap in the uptake of buprenorphine prescribing in HIV care settings. To improve integration of OUD care and HIV primary care, we recommend (1) all HIV clinicians obtain a buprenorphine waiver, (2) teaching on OUD should be integrated into infectious diseases and HIV continuing medical education, and (3) previously validated models of integrated care should be leveraged to urgently expand access to buprenorphine for persons with HIV and OUD.
Training in office-based opioid treatment with buprenorphine in US residency programs: A national survey of residency program directors. [2019]The prevalence of opioid use disorder (OUD) has increased sharply. Office-based opioid treatment with buprenorphine (OBOT) is effective but often underutilized because of physicians' lack of experience prescribing this therapy. Little is known about US residency training programs' provision of OBOT and addiction medicine training.
Increasing Access to Medications for Opioid Use Disorder in Primary Care: Removing the Training Requirement May Not Be Enough. [2021]Substance use disorders, including opioid use disorder (OUD), are understood as chronic diseases with a relapsing and remitting course and no known cure. Medications for OUD (MOUD) are well established with decades of evidence supporting their safety and efficacy; however, treatment access remains poor and inequitable. Buprenorphine is an MOUD that can be prescribed in a primary care outpatient setting, although regulatory and administrative challenges are a barrier to prescribing it. Recent regulatory changes offer an opportunity to expand the number of family doctors who treat OUD.