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Magic mushroom compound tested as opioid addiction aid

NCT ID NCT04161066

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This early-phase study is testing whether adding two doses of psilocybin (the active ingredient in magic mushrooms) to standard buprenorphine/naloxone treatment is safe for adults with opioid use disorder. Ten participants will receive psilocybin along with counseling, while researchers monitor side effects, withdrawal symptoms, and changes in cravings. The goal is to see if psilocybin can safely support existing medication-assisted treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
psilocybin
What this could lead to
If it works, this could point toward a new way to help people with opioid use disorder stay in treatment and reduce cravings.
What could go wrong
This is a very small, early-phase safety study with only 10 participants, so results may not apply widely. Psilocybin can cause intense psychological effects and is not yet proven effective for this condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 (at least 5 of last 30 days if already on buprenorphine/naloxene. See exclusion #1). Misuse will be defined as either: 1. Use of illicit opioids, such as heroin or street fentanyl; or use of a prescription opioid (such as oxycodone, morphine, or hydrocodone) through a route (e.g. nasal, injected) other than FDA approved , and/or 2. Use of a prescription opioid 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 months 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53705, United States

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