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Can a single psilocybin dose help break meth addiction?

NCT ID NCT07774702

Disease control Sponsor: Peter Hendricks Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial investigates whether a single dose of psilocybin, given during a supervised session and paired with brief cognitive behavioral therapy, can help adults with moderate to severe methamphetamine use disorder reduce or stop their use. Participants receive one of two dose levels of psilocybin and are followed for up to six months to track abstinence. The study aims to see if this approach can support long-term recovery from methamphetamine dependence.

What this could mean

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

Active substance
psilocybin (a single oral capsule) combined with cognitive behavioral therapy
What this could lead to
If successful, this could point toward a new treatment option for methamphetamine use disorder, potentially helping people achieve and maintain abstinence.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply broadly. Psilocybin can cause intense psychological effects, and the trial's success depends on careful supervision and follow-up.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 42 people

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

Expected to start

Feb 2027

An estimate. Start dates often move.

Expected to finish

Feb 2032

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

18 years and older

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: * Age 18+ * DSM-5 moderate or severe Methamphetamine Use Disorder * Severity of Dependence Scale score ≥ 4 * Methamphetamine use on more than 7 of the past 30 days and more than one positive urine test before randomization * A goal of complete abstinence on the Thoughts About Abstinence questionnaire * Able to read, write, and speak English * A friend or family member available for post-session release * Good general health by history and physical * Confirmed pre-dose abstinence of at least 24 hours (clinically assessed) Exclusion Criteria: * Pregnancy or breastfeeding, or not using effective contraception * Current psychiatric diagnoses other than a mild substance use disorder or tobacco/nicotine use disorder * Current hypertension (\>140/90 at rest) * Regular use of centrally acting serotonergic medications or MAO inhibitors (washout/re-screen permitted) * Personal history of any psychotic or bipolar I/II disorder, or a first- or second-degree relative with such * Current suicidal or homicidal ideation * Plan to relocate within 6 months * Psychedelic use in the past 3 years, more than 3 lifetime psychedelic occasions, more than 3 lifetime ketamine or MDMA occasions, or any prior 5-MeO-DMT or ibogaine use

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Conditions

The condition(s) this trial relates to.

methamphetamine dependence substance-related disorder

As listed by the trial registrant

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

Methamphetamine use disorder

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 Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

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