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Can a psychedelic inhaler lift depression fast?

NCT ID NCT07562191

Symptom relief Sponsor: Universidade Federal do Rio Grande do Norte 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This study tests whether inhaling DMT, a psychedelic drug, can quickly reduce symptoms of major depression and suicidal thoughts. 140 adults with moderate-to-severe depression will receive either a high or low dose of DMT in two puffs. Those not improved after a week can get an extra high-dose session. Researchers will track mood and safety for up to a year.

What this could mean

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

Active substance
N,N-Dimethyltryptamine (DMT) inhaled via vaporizer
What this could lead to
If it works, this could point toward a fast-acting treatment for major depression and suicidal thoughts.
What could go wrong
This is a mid-stage trial with only 140 people. The high dose may cause intense psychedelic effects, and it's unclear if benefits last or beat existing treatments.

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 140 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 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

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: * 18 years or older, capable of making decisions, and able to provide informed consent. * Major Depressive Disorder (MDD) according to DSM-5 criteria * Current depressive episode of moderate to severe intensity * Episode duration of at least two weeks * Baseline MADRS score ≥ 20 * No treatment changes (including antidepressants) in the 4 weeks prior to the study * Abstain from psychedelics ≥14 days before dosing (D0) Exclusion criteria: * Major cardiac, hepatic, or renal disease; unstable cardiovascular conditions * Uncontrolled hypertension, QTc prolongation, arrhythmias, or valvular disease COPD or asthma * Severe obesity, uncontrolled diabetes, coagulopathy, thyroid disease, or glaucoma * Neurological risk (e.g., aneurysm, ↑ICP, epilepsy/seizures, severe disorders) * MAO deficiency or history of serotonin syndrome * Pregnant, breastfeeding, positive test, or no effective contraception * Secondary depression * Cluster B personality disorders (incl. borderline with ≥2 suicidal behaviors in past 12 months) or poor therapeutic rapport * Psychotic disorders, MDD with psychotic features, or first-degree family history of psychosis/bipolar disorder * Mania/hypomania * OCD, dissociative disorders, active PTSD, or decompensated eating disorders * Moderate-severe use disorder (past 6 months; except nicotine/caffeine) * Lifetime ketamine, PCP, psychedelics, or MDMA use disorder * Current use of MAO inhibitors, unless discontinued at least 14 days prior to dosing * Psychedelic trial participation in past 12 months * Cognitive impairment affecting valid assessment

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Conditions

The condition(s) this trial relates to.

endogenous depression major depressive disorder Suicidal Ideation Suicide

As listed by the trial registrant

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

Major depression Major depressive disorder (MDD) MDD Suicidal ideation Suicide

How to take part

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

  1. The places running it

    5 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

  • Complexo Hospitalar Universitário Professor Edgard Santos, Federal University of Bahia (HUPES-UFBA)

    NOT_YET_RECRUITING

    Salvador, Estado de Bahia, Brazil

  • Hospital Universitário Onofre Lopes - HUOL - UFRN

    RECRUITING

    Natal, Rio Grande do Norte, Brazil

  • Hospital de Saúde Mental Professor Frota Pinto

    NOT_YET_RECRUITING

    Fortaleza, Ceará, Brazil

  • Instituto de Psiquiatria - Hospital das Clínicas - IPq - HC - USP

    NOT_YET_RECRUITING

    São Paulo, São Paulo, Brazil

  • Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro (IPUB-UFRJ)

    NOT_YET_RECRUITING

    Rio de Janeiro, Rio de Janeiro, Brazil

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