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Magic mushroom compound tested for smokers in pain

NCT ID NCT07118332

Symptom relief Sponsor: Yale University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Updated 3 times

Summary

This early-phase study at Yale will test whether a single 25mg dose of psilocybin is safe and well-tolerated in 10 veterans who smoke daily and have chronic pain. Researchers will monitor side effects and explore whether the drug can improve pain and boost motivation to quit smoking. Psilocybin is not yet approved for any medical use in the U.S.

What this could mean

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

Active substance
Psilocybin (the active ingredient in magic mushrooms)
What this could lead to
If it works, this could point toward a new way to ease chronic pain and help people quit smoking at the same time.
What could go wrong
This is a very early, small trial with only 10 people, so results may not apply widely. Psilocybin can cause intense psychological effects and is not yet approved for medical use.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 10 people

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

Started

Jul 2026

Expected to finish

Dec 2027

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: * Veterans aged 21 to 65 years, who have been smoking tobacco cigarettes daily cigarettes for at least a year (confirmed with urine cotinine strips indicating smoking status (28) * not seeking treatment at the time of the study for tobacco use. * endorsement of bothersome or high-impact chronic non-cancer pain per the Graded Pain Scale - Revised (29); * in good health as verified by medical history, screening examination, and screening laboratory tests; and * body mass index (BMI) between 18 to 35 because there is limited information on the safety of psilocybin in individuals outside this range. * for women, not pregnant as determined by pregnancy screening, nor breastfeeding, and using acceptable birth control methods (e.g., oral contraceptives). Exclusion Criteria: * History of major medical disorders (e.g., diabetes, epilepsy, kidney or liver diseases, heart rhythm problems, heart failure, hypertension with BP greater than 140/90mmHg, history of cerebrovascular problems, severe asthma, etc.). * lifetime history of schizophrenia, bipolar disorder, dissociative disorders, or borderline personality disorder, current major depressive episode, or PTSD. * first- or second-degree relatives with a history of bipolar disorder or schizophrenia. * suicide attempt or ideation in the past year. * regular use of certain psychotropic medications (antidepressants, antipsychotics, mood stabilizers or anxiolytics) that are deemed to have the potential for adverse effects or drug reactions with psilocybin including SSRIs and MAO inhibitors. * current untreated moderate or severe substance use disorder for any other recreational or prescription drugs other than nicotine. * known sensitivity or intolerability to psilocybin.

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Conditions

The condition(s) this trial relates to.

chronic pain syndrome nicotine dependence Pain

As listed by the trial registrant

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

Smokers with chronic pain

How to take part

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

  1. The places running it

    2 sites. 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

  • Department of Veterans Affairs

    NOT_YET_RECRUITING

    West Haven, Connecticut, 06516, United States

  • Department of Veterans Affairs

    RECRUITING

    West Haven, Connecticut, 06516, United States

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